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    A Study on Siddha Diagnostic Methodology of Neerkuri and Neikuri for Various Causes of Aan Maladu (Male Fertility)

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    Aan maladu is classified under the Maladu diseases by Sage Yugimuni in his treatise Yugimuni Sikitchasaaram. Siddha diagnostic approach to Aan maladu patients include Envagai thervu (Eight fold examination), Udalkattugal, Yakkai (body type determination). ❖ The author had screened 40 patients of Aan maladu in the Noi Naadal Department of GSMC&H, Palayamkottai. Among those 40 cases were enrolled in the study based on the selection criteria and the diagnostic parameters were applied and observed. ❖ Majority of diseased cases (62.5%) in the study were of 30-39 yrs. This age group seems to be the period of awakening to infertility to get rid of the disorder seeking medical attention. 20% of cases came under 40-49yrs revealed history of long standing treatment failure, late marriages, failure of assisted reproductive therapies which may be due to age factor of men and his partner. 17.5% of cases came under 21-29yrs. ❖ Most of patients (97.5%) were non vegetarians. Non-vegetarian diet which is considered as thamo gunam food seems to alter the body’s mind and soul. Thamo gunam would alter reproductive ability also. ❖ Among 40 cases, 45% of cases were coolie (farmer, weaver, plumber, construction worker. etc.) 12.5% cases were driver, 12.5% cases were in mechanic, 12.5% cases were in engineer, 5% cases were in teacher, 5% were cases in bank manager, 2.5% case were in police, chef, Beauty parlour worker. Majority of cases were working in hot atmosphere. These are the suitable conditions for derangement of Pitham, which can affect along with Vatham to cause Varicocele, Premature ejaculation and Reduced semen production. ❖ Among 40 patients, 82.5% patients had Premature ejaculation: 30% patients had Erectile dysfunction; two features remained as a significant concomitant reproductive abnormalities in these study group. 22.5% patients had Scrotal pain, 12.5% had lower abdominal pain during sexual intercourse, 12.5% had loss of sexual desire, 7.5% had Nocturnal emission, Retrograde ejaculation and low back pain during sexual intercourse. As per Siddha text, Vali derangement with Azhal results in Premature ejaculation. Hence Vali azhal derangement was seen in 80% of patients. ❖ Association was observed 22.5% patient had Smoking habit, 17.5% patient had Alcoholism, 10% patient had Tobacco chewing. In addition habit of tobacco, alcohol reduces conceptive ability of semen. 2.5% of patients had history of mumps. The observation goes to validate the literary stating about Karumpanisai ammai and Pootuthaal ammai mentioned in Siddha literature which are considered to be viral/pox illnesses notorious to precipitate infertility in men. ❖ Out of 40 cases, 50% of patients had Pitha vatham, 35% had Vatha pitham,7.5% had vathakabam,7.5% had Kaba pitham. From the pulse study it is inferred that majority of cases 50% had Pithavatham. 35% had Vatha pitham. As per sathaga naadi and agathiyar, Male infertility related pulse appraisal were: • Pithavatha Naadi • Vatha Pitha Naadi • Pithathil vayu Naadi • Vatha Naadi. As given in the text majority of aan maladu patients had Pithavatham and Vatha Pitham naadi. ❖ Out of 40 cases, 50% of cases had the disease for 1-2 years, 25% of cases had the disease for 3-4 years and 7.5% of cases had the disease for 5-10years. Majority of the cases suffering from this disease had duration of 1-2 years. 17.5% of case had the disease for more than 10years, revealed history of failure of assisted reproductive therapies, nil sperm count. Azoospermia and oligoasthenospermia seems to be prevalent in this 20% patients. ❖ As per siddha text Kabam Udal people are more prone to (“Inthiriyakuraivullavan; Pillaipaetril Kuraindhavan”) reduced capacity to procreate and Pitham udal are prone to (“Arpa sukkilam”) oligospermia. This is revealed in the study as the most of patients were of Kaba Pitham body type (32.5%). All the cases have affected Sukkilam and Saaram. Majority of cases more than 70% had all that thus affected. According to theraiyar Food nourishes semen on the seventh day after ingestion. The interruption in the nourishment chain of udal thathu in most of patients affected the production of semen. Medicine of selection should enhance the quality of affected udal thathu to get rid of semen abnormalities for these patients. CONCLUSION: The Diagnostic procedures of Siddha may be an age-old method; however, it is time-tested and has been proved successful by the generations of Siddha community. The study revealed that majority of Aan maladu patients had either Vatham (Out of 40 cases, in 95.0% of patients Viyanan get affected. 27.5 % had affected Abanan, 32.5 % had affected Samanan,17.5% had affected Pranan, 7.5 % had affected naahan, 5% had affected Thevathathan) or Pitham (Out of 40 cases, 15% had deranged Analam, 12.5% of cases had deranged Prasagam, 2.5% had deranged Ranjagam, 2.5% of cases had deranged Aalosagam, 100% of cases had deranged Saadhagam) derangement as the primary cause. Pithavatham and Vatha pitham were the Pulse appraisal seen in most of the patients (50% of patients had Pitha vatham, 35% had Vatha pitham, 7.5% had vathakabam, 7.5% had Kaba pitham). Earlier Diagnosis indicated by pacifying the alleviated kutram and strengthening the udal thathukkal, the disease male infertility may be easier one to overcome successfully. Need for further research on a larger group of patients to arrive at more definite conclusions has been felt

    A Toxicity study on Gandhi Mezhugu

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    Gandhi Mezhugu is prepared according to the process found in the text The Siddha Formulary of India Tamil (Part -1). This well known drug is used in Siddha practices, by a large number of siddha physicians. ❖ The aim of this dissertation is to study the acute and chronic toxicity of the drug Gandhi Mezhugu, administered at various presumed moderate dosage, in the experimental animals. ❖ In Review of literature, the ingredients of Gandhi Mezhugu are discussed in depth, with focus of special features and medicinal uses, especially for the diseases such as Meganeer noigal like Vegumoothiram, Sori, Sirangu, Tholnoi, Eruvaimulai noigal. ❖ These minerals are purchased from registered raw material supply shop - Rajendra herbal store. Thuckalay, Kanyakumari District. ❖ The drugs are authenticated by the HOD, Department of Gunapadam, Government Siddha Medical College and Hospital, Palayamkottai, Thirunelveli. ❖ The raw samples were taken for purification and test medicine was prepared, as per the method narrated in the literature. Then the medicine was prepared in GSMC Gunapadam lab as per the literature. ❖ Physiochemical study: Qualitative parameters of GM is Semisolid, Nonsticky, Garlic odour, water soluble, Pungent. ❖ Quantitative parameters of GM: The percentage of loss on drying og GM was1.20±0.540. since the loss on drying of GM is with in the normal limit. So, the stability of the drug is higher. The water soluble and acid soluble extract values provide an indication of the extent of polar and non-polar copmpounds respectively present in GM. The extract values of water in GM is 8.70±0.510. ❖ Biochemical analysis of GM indicated the presence of Sulphate, Chloride, Starch, Ferrous iron, Unsaturated compound, Amino acid. ❖ Biological screening (sterility test, specific pathogen Aflatoxins& Pesticide residue) reveals results of the Gandhi Mezhugu shows the specific pathogen are not detected and AflatoxinsB1, B2, G1, G2 are not detected. And then Organo chlorine pesticide Alpha BHC, Beta BHC, gamma BHC, Delta BHC, DDT and endosulphan are not detected. Organo Phosphorus: Malathion, Dichlorovus and chlorpyriphos are not detected. Oragano carbomates: carbofuran not detected, Pyrethroides: Cypermethrin are not detected. ❖ Instrumental Analysis: ◉ FTIR ANALYSIS: It shows the presence of Alcohol, Amine salt, Carboxyclic acid, Conjugated acid halide, Carboxyclic acid, 1,2,4-Trisubtituted , Alkene, Halo compound, Alkyl & Aryl Halides. ◉ ICP OES results reveal that below detection limit level (BDL) of Aluminium, Arsenic, Calcium, Cadmium, Chloride, Copper, Iron, Mercury, Lead And result indicates the presence of Carbon, phosphorous, sulphur elements in the Gandhi Mezhugu. ◉ SEM: Observed from Scanning Electron Microscope (SEM) photographs that particles were stabilized and have irregular morphology. The particles were distributed in rage 5 microns and the size is below 10 microns. ◉ GCMS Study The phyto chemical analysis by GCMS analysis of the GM revealed the presence of five compounds namely, 4,6 Dimethoxxynaphthalen-1-y)methylene, 4,6,9-Nonadecatrine, Strychane, 1 acetyl-20a –hydroxy-16methylene, Hexadecanoic acid, methyl ester, Dasycarpidan 1-methanol, acetate (ester). ◉ HPTLC finger printing analysis of the of the Gandhi Mezhugu reveals the presence of four prominent peaks corresponds to presence of four versatile phyto components present with in it. Rf value of the peaks ranges from 0.03 to 0.92. ◉ Toxicity study results: In acute oral toxicity was done as per OECD guideline- 423 with levels four different dose (5mg/50mg/300mg/2000mg) of Gandhi Mezhugu were administred stepwise manner. throught out the 14 days of observation period, body weight of animals were recorded once in a week there is no mortality and Daily the animals were observed for clinical signs of toxicity were observed in GM treated groups. The results of the acute oral toxicity study indicate that the LD50 is more than 2000 mg/kgb.wt of the animal. There were no physical and general behavioural changes observed in wistar albino rats. Body weight of all animals did not reveal any significant change as compared to vehicle control group. Food consumption of all group animals were normal. Finally, the Mortality was not observed in all treated groups. The motor activities were normal in all the 5 groups of animals This acute toxicity study results reveals that Gandhi Mezhugu was non toxic upto a dose level of 2000 mg/kg body weight of animal. ◉ Sub acute toxicity study-Repeated oral toxicity study was conducted for 28 days as per the OECD guideline - 407 in 4 doses all animals from control and all the treated dose groups survived throughout the dosing period of 28 days. control group were 1 ml of milk with 1 ml of distilled water. low dose, mid dose, high dose 36 mg/ 180mg/ 360mg respectively, there was no significant change in, water and food intake. there were no significant changes in the haematological and biochemical parameters. Histopathology study shows that organs such as brain, heart, lungs, stomach, liver, spleen, kidney .testes, ovary and uterus was normal in control and high dose groups. The observations included clinical signs of toxicity, food intake, water intake, body weight. No signs of toxicity were observed. There was no significant changes in food intake, water intake and body weight. No mortality occurred till the last day of the study. The blood samples are used to evaluate haematological parameters (like SGOT, SGPT and ALP. Urea, Creatinine, Bilirubin). No changes in haematological parameters and biochemical parameters in low, middle and high dose (36 mg/kg, 180mg/kg, 360mg/kg). On completion of the 28 days of drug administration, wistar albino rats were sacrificed. In macroscopic examination the heart, kidneys, liver, brain and spleen were weighted. The organs were normal when compared with control group. ◉ Histopathological examination does not reveal any abnormalities, in all treated dose group level when compared with control group, reveals the action of drug in every dose level does not damage the organs. there is no pathological changes occur in all group of animals during the study period. These findings were desire the safety of Gandhi Mezhugu used in siddha system of medicines CONCLUSION: Gandhi Mezhugu was studied for its acute and sub-acute toxicity effect using laboratory animals. In acute study GM did not produce any specific toxicity or mortality even at the dose of 2000 mg/kg in wistar albino rats. so no observed adverse effect level (NOAEL) of GM is 2000 mg/kg body weight of animal. In sub-acute toxicity 36mg/kg, 180mg/kg,360 mg/kg of GM was used and it was administered once daily for 28 days through oral route so the result clearly demonstrate the Gandhi Mezhugu can be considered safe, as it did not cause either lethality or adverse changes with general behaeviour of rats and there was no observable detrimental effects (36mg/kg, 180mg/kg.360mg/kg) over the period of 28 days. Haematological and histopathological parameters are normal limits and no significant abnormality present in internal organs. These finding confirm that the therapeutic dose level of 100- 200mg/kg b.w for man which is mentioned in "The Siddha formulary of India part-I (Tamil)" is safe dosage for clinical use. From the biological and pesticide screening, physiochemical analysis, biochemical analysis, instrumental analysis, it is inferred that safety of the drug was once again confirmed. Taken as a whole safety profile of the Gandhi Mezhugu was well established. This is just a preliminary study and it will be useful for further researches

    A Toxicity study on Kabangusa Chooranam

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    This research Aim was to Evaluate the Safety Profile of Siddha Drug - “KABANGUSA CHOORANAM” and authenticated siddha referenced medicine obtained from; Chikitsarathina Deepam – part II, First Edition, Vaithiya chindhamani by vaithiya vithvanmani Kannusaami pillai .S, Rathina naayakkar & Son‟s publications (Page No. 166). KBC ingredients were, Purified chukka (35g), Purified Milagu (35g), Purified Thippili (35g), Purified Chittaratai (35g), Purified Akkarakaram (35g), Purified Omam (35g), Purified Desavaram (35g), Purified Kadukkai (35g), Naatu sarkarai (280g). The medicine prepared, as per the method mentioned in the Siddha literature. Indicated for Kapha Rogam (Respiratory diseases). ❖ In review of literature, the ingredients of Kabangusa chooranam were discussed in depth with a special attention paid to their medicinal uses and toxicological aspects. ❖ The prepared medicine KBC characterized as per PLIM guidelines and instrumental analyses. Finally Evaluated the Acute toxic effect of KBC in rats as per OECD 423 guidelines and the Sub-acute toxic effect of KBC in rats as per OECD 407 guidelines. ❖ According to the results and observations of the Acute toxicity study of siddha drug Kabangusa Chooranam (KBC) as LD50 was greater than 2000mg/kg body weight in Wistar Rats. In sub-acute toxicity evaluated Repeated dose 28 days oral toxicity study of Kabangusa Chooranam revealed that the NOAEL (No Observed Adverse Effect Level) of Kabangusa Chooranm should be greater than 1800 mg/Kg b.wt and the drug is safe for human consumption. In Low Dose- 180mg/kg bodyweight was no significant different in any hematological and the gross & histopathology changes therefore clinically safety to oral administration of KBC was (Therapeutic Dose is equal to Low Dose) 180mg/kg body weight in rats in repeated oral dose 28 days period. ❖ KABANGUSA CHOORANAM (KBC) is safety in biological aspect, characteristic way of chemical constituents and toxicological evaluation on Acute & Subacute toxicity study proved as per Siddha Text reference by 180mg/kg body weight as therapeutic dose of mentioned indications. CONCLUSION: From the above discussion following conclusions have been drawn to satisfied the objectives and achieved the research aim through the above results. Kabangusa Chooranam was taken as test drug, prepared using authenticated siddha literature. And it was characterized by Brownish, Very fine, solid state, strongly aromatic, soft, moderately free flowing. The quality parameters and safety profile of the drug were analyzed as per standard protocol. The qualitative and quantitative analysis of Kabangusa chooranam proved the quality and purity of the drug. The quality assessment results will be used as standard for future research on Kabangusa chooranam. According to the Results and observations of toxicity study of Siddha Drug Kabangusa chooranam (KBC), the Acute toxicity study results did not show any mortality, behavioural changes and drug related toxicity. From the Acute toxicity study, it is revealed that KBC is not toxic at a maximum oral dose level of 2000 mg/kg in Wistar rats. So, the median lethal dose (LD50) of KBC is greater than 2000 mg/Kg.b.wt. In Repeated Dose 28 Day oral toxicity study, haematological and biochemical parameters of 1800mg/kg b.wt test drug treated animals were within normal limit and histopathological parameters showed no significant changes in internal organs compared with control group. So, the No Observed Adverse Effect Level (NOAEL) of KBC is greater than 1800mg/kg.b.wt. Hence, the safety of Kabangusa Chooranam is proved through this study. So, the recommended human dose may not produce any ill effects and this must be proved by further clinical trials, Pharmacological studies and efficacy studies. This dissertation work is the first step for continuous research in this title. This research Evaluates the Safety Profile of Siddha Drug “KABANGUSA CHOORANAM” by characterization and toxicological study, which gives preventive, promotive, curative, and rejuvenative health for many diseases in the world

    An open clinical trial on Varma thadaval (Varma manipulation therapy) with Varma vatha ennai in the management of Kumba vatham (Periarthritis shoulder)

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    The study was conducted after approved by the Institutional Ethical Committee (NIS/IEC/2020/D-9) and the trial also registered in Clinical trial registry of India (CTRI/2021/07/035149). Hence the study is safely executed on patients and there were no adverse drug reactions noted during the study period. ❖ The Trial drug Varma vatha ennai was prepared in the Gunapadam practical laboratory of National Institute of Siddha, after getting proper authentication of raw drugs from the Medicinal botany department at National Institute of Siddha, Chennai-47. The trial drug was prepared by the standard operating procedure as mentioned in the protocol under the supervision of faculty members of department of Varma Maruthuvam. ❖ The detailed study on Kumba vatham (Periarthritis Shoulder) with reference to its aetiology, pathogenesis, investigations, clinical features, diagnosis and treatment with trial drugs was done. All the details about the study and Varmathadaval procedure were explained to the patients in their language, dietary regimen and information sheet were given to them and signed consent forms were received. ❖ The clinical Trial on Varma thadaval (Varma manipulation technique) with Varma vatha ennai in the management of Kumba vatham (periarthritis shoulder) were conducted at the Department of Varma Maruthuvam, Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai-47. ❖ 30 cases of both the sexes with the clinical features of Kumba Vatham (Periarthritis Shoulder) were selected in the age group within 30 to 60 for the study. For all the 30 patients, Varma thadaval with Varma vatha ennai was given weekly once andVarma vatha ennai (External) was given continuously over the study period. In every visit the clinical assessment is done and prognosis is noted in the prescribed proformas. Outcome was assessed using SPADI Score. The results are compared at the end of the study. ❖ The prognosis was noted in the proforma and OPD book at every week visit. Radiological investigations was done before treatment to exclude other shoulder pathologies. No adverse effects and any other systemic problems were noted during the treatment period. ❖ The study result was done in all the 30 patients participated in the trial using the SPADI Score.The mean ± standard deviation of SPADI score at before and after treatment were 69.67± 8.68 and 26.67 ±16.366 respectively which is statistically considered as significant (p<0.0001). It shows that the Varmathadaval with Varma vatha ennai given significant results in Kumbavatham. CONCLUSION: The clinical trial attests the effectiveness of Varma thadaval (Varma manipulation therapy) with Varma vatha ennai in the management of Kumbavatham (periarthritis shoulder) ❖ The trial medicines were prepared from easily available ingredients. The mode of treatment is non-invasive and cost effective. Hence such treatment is recommended for Kumba vatham (Periarthritis shoulder). ❖ SPADI Score shows significant reduction in between at the start and end of treatment i.e from 69.67 ± 8.68 to 27.67 ± 16.36. The outcome of this study was observed by SPADI Score, which showed encouraging results of very good improvement in 14 (46.6%) cases, Good improvement in 8 (26.7%) cases, Moderate improvement in 5 (16.7%) cases and mild improvement in 3(10%) cases. ❖ However further work with large number of samples should be carried out towards finding the ideal response

    An Open Labeled Double Arm Non Randomized Phase II Clinical Trial to Evaluate the Efficacy of Siddhar Yoga Maruthuva Muraigal and Siddha Medicine Kandankathiri Samoola Chooranam in the Management of Peenisam (Sinusitis)

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    A collective study of the disease Peenisam is made covering the all aspect of the disease enclosing siddha and modern aspect. Study during drug standardised are botanical, biochemical, these are supportive of trial drug for our peenisam. ❖ 40 cases with peenisam were diagnosed clinically, every 20 patients have received Siddhar yogam therapy alone (Pranayamam, Trikonasanam, Bhujanasanam and savasana) and another 20 patients have received Siddha internal medicine Kandankathiri samoola chooranam and all the patients observed for clinical diagnosis, laboratory investigations and treating of trial medicine. ❖ The peak age incidence of peenisam 30-55 years age group. Clinical diagnosis of the above disease was done on the basis of clinical features described in Siddha maruthuvam. Before admission for study their careful detailed history of the sufferings, duration, their occupation, nativity etc, are elicited for the 40 patients. ❖ Biochemical analysis of Kandankathiri samoola chooranam shows that the presence of Chloride, Sulphate, Amino acid, Ferrous Iron and unsaturated compound in it. ❖ During treatment all the patients keep under pathiyam and a specific dietary regiment, It has been clearly mentioned in review of siddha literature. Daily improvement was observed to assess the efficacy. ❖ The result obtained were found to be Siddhar yoga therapy is effective. No adverse reactions were found, Hence the trial drug was found to safe and effective. CONCLUSION: 40 patients (Both OPD and IPD with as comparative study with trial medicine) were treated for this dissertation work . Siddhar yogam therapy alone for 20 patients and Kandankathiri samoola chooranam (Int) for 20 patients. ❖ The clinical study shows significant decrease in the symptoms of the disease. The Siddhar yoga therapy gives a good confidence in the management of Peenisam and economically very low cost. No contra indication was noted in the course of treatment. ❖ Finally concluded that the trial medicine Siddhar yogam therapy is effective than Kandankathiri Samoola Chooranam in the treatment of Peenisam

    Phase II Non-Randomized Comparative Open Clinical Evaluation on “Thandagavadham” (Lumbar Spondylosis) treated with “Siddhar Yoga Therapy” and Internal “Chukku Karpam”

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    The 40 cases of Thandagavatham were diagnosed clinically. Among 40 patients, 20 patients were treated with Siddhar Yoga Theraphy treatment along with the Internal trial drugs and the rest 20 patients underwent Siddhar Yoga Theraphy in both inpatient & outpatient wards for 48 days ie. followed up by a visit for once a week prior to a time period of 7 weeks in Department of Siddhar Yoga Maruthuvam of the Government Siddha Medical College, Chennai – 106. The Study Protocol was approved by Institutional Ethics committee (GSMC-CH-3401/ME- 2/024/2019). Before initiating the clinical trial, it was registered in Clinical Trials Registry of India and the registration number Ref No Is: CTRI/2021/07/035190. ❖ The distinct Siddha methods of examination for the disease were carried out and the data were recorded in the prescribed Proforma for the 40 selected cases. ❖ During the period of treatment all the patients were instructed for Pathiyam (specific dietary regimen chart for the disease given to each patient). ❖ Laboratory investigations are done periodically for all the cases before and after treatment and radiological investigations are done for all the cases before treatment. ❖ The observations made during the clinical study showed that internal trial drug & Siddhar Yoga Theraphy are effective in relieving the pain in Thandagavatham patients. During the study period, there was no adverse event reported. As per the Siddha Literature and recent research articles, the ingredients of the trial drug was found to have anti inflammatory, immunomodulator ,anti- oxidant, analgesic properties owing to the disease manifestations. ❖ The mean pain score before treatment was 7.6, after treatment it was reduced to 3.65. Hence, this study reveals that patients treated with Internal trial drugs and Siddhar Yoga Theraphy showed good enhancement when compared to those who are treated only with Siddhar Yoga Theraphy. Statistical analysis showed significant reduction in the pain score and in the related questionnaire before and after treatment. The outcome of the trial medicine & Siddhar Yoga Theraphy was assessed by grading method and the results were as follows: Good improvement - patients (60%), Moderate improvement - patients (27.5%), Mild improvement - patients (12.5%). CONCLUSION: ❖ Low back ache is a prevailing problem and has a ubiquitous distribution. Among the expansive causative factors both spinal and extra spinal, the frequent cause of low backache seems to be the lumbar disc disease. Bad posture plays a very significant role in the genesis of this disease. ❖ Thandagavatham is mainly due to derangements of Vadha humour in the body. ❖ The Chukku Karpam revealed no toxicity in the preclinical studies and hence proved to be safe for human administration. ❖ The clinical trial proves the efficacy of the trail drug by reducing the clinical signs and symptoms like radiating pain, numbness, restricted movements and provides better improvement. The study results show that of 12.5 % of them had mild improvement, 27.5% of them had moderate improvement and 60% of them had good improvement after treatment. Thus these results revealed good relief from the disease after treatment. ❖ The preparation of trial medicine is economical. The trial Medicine were formulated from easily available ingredients and the palatability of medicine is better and the dosage is also convenient. Patients treated with internal trial drug and Siddhar Yoga Theraphy showed good enhancement when compared to those who were treated only with Siddhar Yoga Theraphy . When these affected individuals get a better management with this trial drug and Siddhar Yoga Theraphy, it would be a great handy medication. ❖ In the present study , there was no dreadful effect were reported in clinical trial. Hence the drug were proven for their safety. The clinical trial conducted in selected patients was up to scratch. Further studies may be taken up to establish the efficacy of the drug. ❖ Therefore, the author concluded that the trial medicine “CHUKKU KARPAM (INTERNAL) “along with “SIDDHAR YOGA THERAPHY” can give better upshot for Thandagavatham (Lumbar Spondylosis)

    An Observational study to Compare the Pattern of Recovery of Corneal Sensations following Two Types of Cataract Surgeries, using the Cochet-Bonnet Aesthesiometer and Its Correlation to Ocular Surface Symptoms

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    AIM: To study the pattern of recovery of corneal sensations following two types of cataract surgeries i.e., Phacoemulsification Cataract Surgery (PCS) and Manual Small Incision Cataract Surgery measured (MSICS) using Cochet-Bonnet aesthesiometer and its association to the ocular surface symptoms. OBJECTIVES: To quantify change in ocular surface symptoms, dry eye parameters and corneal sensations following cataract surgery and analyse pattern of recovery, on follow up. To find the correlation between the ocular surface symptoms, dry eye parameters and change in corneal sensations during the post-operative visits, following the two methods of cataract surgeries. METHODS: In this study, all patients aged 40 years and above, who were undergoing cataract surgery, fulfilling the inclusion criteria and willing to participate in the study, were considered and the first 100 patients undergoing each type of cataract surgery (PCS or MSICS) were recruited for the study. In these patients, pre-operative baseline assessment of ocular symptoms by Modified SPEED Questionnaire, measurement of corneal sensations using Cochet-Bonnet aesthesiometer and assessment of dry eye parameters with Schirmer’s test I (for aqueous deficiency) and Tear film breakup time (TBUT) (for evaporative dry eye) was done. After the patients underwent their respective planned surgeries, they were followed up at 7 to 10 days, at 6 weeks (± 1 week), at 3 months (± 2 weeks) and at 6 months (± 1 month) from the date of surgery and all parameters, including the questionnaire and corneal sensations were measured at each of the follow up visits. These parameters were compared, to analyse the trend of recovery and also to determine their correlation with the recovery of corneal sensations. RESULTS: The ocular surface symptoms, Schirmer’s test I, TBUT and corneal sensitivity were more adversely affected in the MSICS Group than in the PCS Group, in the immediate post operative period; the difference between the two groups being statistically significant. In the PCS Group, the parameters reached closer to the pre-operative baseline by the 3-month post-operative visit itself and mostly completing recovery by the 6-month follow up visit; whereas, in the MSICS Group, the parameters were seen to be lagging behind, with the ocular surface symptoms and dry eye parameters still yet to reach the pre-operative baseline even at the 6-month follow up visit. Both types of surgeries also showed a strong linear correlation between the parameters measured in the early post-operative period. The corneal sensitivity showed a strong positive linear correlation with the Schirmer’s Test I and TBUT whereas, an inverse linear correlation was seen with the ocular surface symptoms (Modified SPEED score). As the patients in both groups were followed up, the strength of correlation gradually became weaker, and became mostly negligible by the 3-month follow up visit itself in the PCS Group, whereas there was still a persisting weak association in the MSICS Group, indicating that recovery was slower and still ongoing in the MSICS Group. CONCLUSION: PCS inflicts lesser damage on the corneal nerves as compared to MSICS, thus inducing lesser ocular surface changes. It provides a quicker recovery of the corneal nerve function which is paramount in maintaining a healthy ocular surface. It is important for clinicians to be aware of these changes and counsel patients undergoing surgery, to address their expectations, leading a better post operative experience for the patient

    An Observational Cross Sectional study to Analyze Changes in the Foveal Avascular Zone in Myopes In Comparison with Emmetropes using Optical Coherence Tomography Angiography and Optical Coherence Tomography

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    OBJECTIVE: 1. To study the changes in the Foveal avascular zone of the retina in patients with mild and moderate myopia. 2. To study Retinal and Choroidal changes in myopes 3. To compare the superficial and deep FAZ and Superficial retinal vessel density (SRVD) between myopes and emmetropic controls. 4. To compare the foveal, parafoveal thickness of the retina and sub foveal choroidal thickness between myopes and emmetropes METHODS: A hospital based cross-sectional observational study of patients, with myopia between the age group 18 and 45 years, attending the outpatient services fulfilling the eligibility criteria and age matched controls were recruited for the study after obtaining informed consent. Myopia was defined according to World Health Organisation, 2015 guidelines. Hence the study population was divided into 2 groups, namely Group1: Myopes, Group 2: Emmetropes. The study was conducted in the Department of Ophthalmology, Christian Medical College Vellore, which is a tertiary care teaching centre in South India, from July 2020 to November 2021. Those willing then underwent a detailed eye examination with their respective doctors and then they were referred to the Primary investigator (PI) for this study. An informed consent was then got from the participant by the PI. PI assessed the eligibility of the patient to be recruited in the study, based on the inclusion and exclusion criteria as mentioned below. Informed consent in Tamil or English were taken based on the language they could understand. As mentioned earlier, a complete ophthalmic examination was done for these patients too to make sure they fulfil the eligibility criteria. Demographic details such as Name, age, gender, address, and phone number were asked to patients and entered in the proforma. Systemic history of the patient which included their systemic co-morbidities such as Diabetes mellitus was noted, as it was an exclusion criterion. Ocular history such as, history of glaucoma, previous intra-ocular surgery, history of uveitis, history of taking oral medications like Chloroquine, Hydroxychloroquine, history of using any topical eye medications were all enquired in specific, as all these were part of the exclusion criteria. The optometrist assessed and recorded the Best Corrected Visual Acuity (BCVA) for all the subjects, using Snellen’s chart. Following this, all the subjects underwent a complete ophthalmologic examination, by the treating ophthalmologist including anterior segment examination, measurement of intraocular pressure using Goldmann Applanation tonometry and binocular slit lamp fundus examination using a 78D or 90D lens. After a complete ophthalmological examination, all subjects who fulfilled the inclusion criteria were directed to the principal investigator for an informed consent, review of investigation and further evaluation. The principal investigator then assesses the subjects’ refractive error status and divides them into two groups – myopes and emmetropic controls. The grouping into myopes and emmetropic controls, were done based on the definitions given by World Health Organisation, WHO 2015 guidelines. - Mild and moderate myopia - Mean Spherical Equivalent: < -0.50D up to -6D and astigmatism within ± 1.50) [WORLD HEALTH ORGANISATION, 2015]. - Emmetropic controls – Mean Spherical Equivalent: +0.50D TO -0.50D). Age matched healthy emmetropic controls, with no history of diabetes, and fulfilling the inclusion criteria, were recruited as healthy controls in the study. All the patients in the control group were also recruited in a similar manner after obtaining informed consent. They underwent a detailed ophthalmological examination, as done for the subjects in the myopia arm, including BCVA, anterior segment examination, IOP measurement and posterior segment examination. In the study subjects – myopes and emmetropic controls, mean spherical equivalent was calculated based on their refraction. They then underwent Optical coherence tomography (OCT) testing, from which the foveal, parafoveal retinal thickness and sub foveal choroidal thickness was measured. This was done using the Swept – Source Optical Coherence Tomography (TOPCON DRI TRITON Plus SSOCT) that uses a wavelength of 1050 nm light source and scanning speed of 100,000 A scans/sec. This information was saved in computer using the hospital number of each patient. The scanning protocol used was as follows – • OCT – Macula Radial Scan Protocol (9mm) and Horizontal Macula Line Scan Protocol (6 mm line). • Through the Radial scan – Foveal and Parafoveal retinal thickness was measured - Foveal thickness from the fixation point, at the central 1mm of the ETDRS grid and parafoveal thickness at 3mm on superior, inferior, nasal and temporal to the fixation point of the ETDRS grid – the average of which was calculated. • Horizontal 6 mm Macular line scan is taken through the fovea up to the disc. The horizontal line scan is used to measure the sub-foveal choroidal thickness. All OCT and OCT-A scans were done between 9am and 3pm. All the measurements were done by the machine’s software, except sub-foveal choroidal thickness, which was manually measured. The study subjects also underwent Optical coherence tomography Angiography (OCT-A) testing for the measurement of FAZ area. OCTA was performed using a commercially available Swept Source Optical Coherence Tomography Angiography (SS-OCTA), TOPCON DRI TRITON Plus SSOCT, with 3 mm x 3 mm images of the macula, that were centred on the foveola. The FAZ area was measured automatically by the machine along the default referral line cross. The centre of the cross was made sure to be positioned at the centre of the FAZ before noting down the measurement. The vessel density in the superficial retinal layer and in the fovea were separately measured by the machine and measurements were documented. The vasculature was segmented between 2.6 μm from ILM to 15.6 μm below IPL for superficial layer (inner vascular capillary plexus), which was the machine default setting. RESULTS: A total of 165 patients were studied. Of this 63 (38.20%) were males and 102 were females (61.80%). The number of patients were 82 in the emmetrope arm and 83 in the myopia arm, almost equally distributed. Myopia was found to be more prevalent in females than in males, which was statistically significant (p<0.006) The Best corrected visual acuity, near vision, intra-ocular pressures and fundus were also analysed between the two study groups and was found that they did not vary between the two groups. There was a statistically significant difference in the SRVD in the superior and nasal quadrants in the right eye. There was a statistically significant difference in the SRVD in the nasal and inferior quadrants in the left eye. SRVD was measured in mm2 The total SRVD was found to be statistically significant in both the eyes. The variation in the FAZ area did not seem to be statistically significant across the two groups, in both the eyes. FAZ was measured in mm2 In myopes, it was found that the FAZ area was larger in females compared to males and was statistically significant (p<0.046). The variation of Foveal thickness was found to be statistically significant (p<0.000) across the two groups, in both the eyes. All the three parameters, FT, PFT and Sub-foveal CT were measured in μm. SRVD – Superficial retinal vessel density FAZ – Foveal avascular zone FT – Foveal thickness PFT – Parafoveal thickness Sub-foveal CT – Sub-foveal choroidal thickness CONCLUSION: 1. In the evaluation of patients with myopia, early changes in the retina and choroid can be effectively detected using the TRITON swept source OCT. 2. FAZ area did not show statistically significant variation between myopes and emmetropes in our study, this may be attributed to the difference in software used in our study, compared to multiple other literatures published. 3. FAZ area in females was enlarged in myopes, compared to males. 4. Superficial Retinal vessel density was significantly reduced in myopes, and shows a further reduction with progressing myopia, especially in the nasal and inferior quadrants – which correlates with the peripapillary RNFL thickness. This may facilitate the understanding of glaucomatous optic nerve damage associated with high myopia, through further research studies. 5. Our study showed a significant reduction in Foveal thickness in myopes compared to emmetropes. However, we did not find a statistically significant variation in the parafoveal thickness and sub-foveal choroidal thickness between the two groups

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