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    Phase II Non-Randomised Open Clinical Evaluation of Siddha Medicine Suringiyathi Chooranam for the Management of Azhal Thalai Nokkadu (Sinusitis)

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    An open clinical evaluation of siddha drug Suringiyathi Chooranam in Azhal Thalai Nokkadu (Sinusitis) was conducted from the year 2019 to 2022 in the Post Graduate Department of Maruthuvam in Govt. Siddha Medical College attached with Arignar Anna Govt. Hospital of Indian Medicine, Chennai. • A total of 40 cases were treated in the Outpatient department. The clinical and Pathological assessment was carried out on the basis of Siddha and Modern aspects. • All the patients were treated with 2 gram of Suringiyathi Chooranam with lukewarm water after food twice a day for duration of 48 days. The responses were assessed once in 7 days for all the patients. • The toxicological study revealed no acute and sub acute toxicity in study drug Suringiyathi Chooranam. • The pharmacological study of Suringiyathi Chooranam shows Analgesic activity in Wister rats by using Edd’s hot plate method and tail flick method. • Among 40 patients who participated in the study, 45% were male and 55% were female. • The peak incidence of Azhal Thalai Nokkadu was found in 18 to 30 years age group (42.50%). • The disease is more common in home makers (30%). • It is seen that people from lower middle (63%) income category has higher incidence of sinusitis. • Regarding diet, the disease is more common among mixed diet category (87.50%). • Regarding personal habits 7.50% were smokers, 15% were alcoholics, 10% were both smokers & alcoholics and 67.50% does not have any such habits. • Regarding to aetiological factor 37.5% were husk of grains and dust exposure has higher incidence of sinusitis. • Chronicity of illness showed that most of them suffered from this illness for duration of 2-6 months (32.5%). • Among 40 patients 15% were having positive family history and 85% does not have any positive family history related to Azhal Thalainokkadu. • Regarding Thinai, most of the patients were from Neithal nilam (72.50%) • In accordance with Kaalam, most of the patients belong to Pitha Kaalam(52.50%) • In respect to Paruva Kaalam, 25% of patients reported in Koothir Kaalam and 60% of patients reported in Munpani Kaalam and 15% of patients reported in Pinpani Kaalam. • The disease is more common in Vatha yakkai patients (35%). • In Poriyaal therthal Mookku (80%), Mei (90%) and kan (22.5%) were affected. After treatment with study drug were Mookku, Mei and Kan recovered. • Regarding Kanmenthiriyam, kai (12.5%), kaal (20%) was affected during before treatment and then after treatment recover from kai and kaal. • In Vatham Before treatment Piraanan (80%), Viyaanan (65%), Udhaanan (72.50%), Samaanan (100%), Naagan (22.5%), Koorman (25%) Kirukaran (60%) Devathathan (60%) were affected. After the treatment with study drug 88% improvement seen in Piraanan, 90% improvement seen in Viyaanan, 88% improvement seen in Udhaanan, 83% improvement seen in Samaanan, 80% improvement seen in Naagan, 80% improvement seen in Koorman, 80% improvement seen in Kirukaran, 60% improvement seen in Devathathan respectively. • In Pitham Before treatment Anar Pitham (35%), Ranjaga Pitham (22.50%), Saadhaga Pitham (75%) were affected. After the treatment with study drug 80% improvement seen in Anar Pitham, 65% improvement seen in Ranjaga Pitham, 88% improvement seen in Saadhaga Pitham respectively. • In Kabam Before treatment Avalambagam (100%), Tharpagam (35%) and Santhigam (30%) were affected. After treatment 80% improvent seen in Avalambagam, 80% improvement seen in Tharpagam and 75% improvement seen in Santhigam respectively. • In Ezhu Udal Thathukkal, Before treatment Saaram (97.50%), Senneer (22.50%), Kozhuppu (15%), Enbu (17.50%) were affected. After the treatment with study drug 90% improvement seen in Saaram, 65% improvement seen in Senneer, 65% improvement seen in Kozhuppu, 70% improvement seen in Enbu respectively. • In Envagai Thervugal Sparisam (47.50%) Naa (22.50%), Mozhi (65%), Vizhi (25%) were affected. After the treatment with study drug 80% improvement seen in Sparisam, 65% improvement seen in Naa, 85% improvement seen in Mozhi, 80% improvement seen in Vizhi, 100% respectively. • Regarding Naadi, Before treatment 22.50% had Vatha Pitha Naadi and 52.5% had Pitha Vatha Naadi, 17.5% had Pitha Kaba Naadi and 7.50% had Kaba Pitha Naadi. After treatment 30% had Vatha Pitha Naadi and 60% had Pitha Vatha Naadi, 7.50% had Kaba Vatha Naadi and 2.5% had Kaba Pitha Naadi. • Regarding Neikuri, Before treatment 15% had Vatha Neikuri, 20% had Pitha Neikuri, 10% had Kaba Neikuri, 32.5% had Vatha Pitha Neikuri, 22.5% had Pitha Vatha Neikuri. After treatment, 10% had Vatha Neikuri, 22.50% had Pitha Neikuri, 5% had Kaba Neikuri, 35% had Vatha Pitha Neikuri, 27.50% had Pitha Vatha Neikuri. • Radiological investigation DNS (12.5%), Frontal sinusitis (25%), L.Maxillary sinusitis (25), R.Maxillary sinusitis (30%), Ethmoid sinusitis(7.5%) were affectected). After treatment with study drug 5%, 7.5%, 2.5%, 2.5% were improved respectively. The p value was <0.5. • ESR 35 cases the ESR level was normal and 5 cases was moderately reduced were after treatment.The p value was <0.5. • 9 patients had elevate absolute eosinophil count (AEC) during before treatment. After treatment AEC level was normal in 34 patients and 6 patients was moderately reduced. The p value was <0.5. • Statistical analysis of clinical features revealed that the p - value is <0.05 there is significant difference between the before treatment and after treatment value. • According to Clinical Prognosis in the current study revealed that p – values (<0.001) are significant in all clinical features, that means prognosis are well improved after the administration of the medicine. It shows that the given drug Suringiyathi Chooranam is significant for the treatment of Sinusitis. • The outcome of the study reveals that among 40 participants, 80% had good improvement, 15% had moderate improvement and 5% had mild improvement. CONCLUSION: Azhal Thalai Nokkadu (Sinusitis) is mainly caused due to derangement of Uyir thathu - Vatham (Piraanan, Viyaanan, Udhaanan, Samaanan, Koorman, Kirukaran, Devathathan) along with Pitham (Anar Pitham, Ranjaga Pitham, Saadhaga Pitham). The ingredients present in the Suringiyathi Chooranam have Kaarppu, Kaippu, Thuvarppu Suvai thus it countervailed the deranged Uyir thathukal and provided ease for all the patients with Azhal Thalainokkadu. Also the trial medicine showed good symptomatic improvement in patients with Clinical Symptoms. The preclinical studies revealed no acute and sub acute toxicity which proves that Suringiyathi Chooranam is safe for human administration. Further the pharmacological study shows that the trial drug Suringiyathi Chooranam possess significant analgesic activity. No adverse effects of the trial drug were reported during the course of the study. As the study drug is palatable and cost effective it can be utilized for huge population in public health sector. Based on all the pre-clinical and clinical evidences, the author concludes that the trial medicine Suringiyathi Chooranam is one of the best choice for treating Azhal Thalai Nokkadu (Sinusitis). Further there is a scope for research on this trial drug if it is done on larger sample size with longer duration for the benefit of the society

    The Effects of Gastrohepatic Pack on Liver Funtions in Subjects with Type II Diabetes Mellitus

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    BACKGROUND: Nature cure is the system of healing based on constructive principles of nature which focuses on health rather than diseases. Disease is nothing but nature’s violation that results in morbid deposition, abnormal composition of body fluid and lowered vitality and health is the result of morbid eliminations, restoring composition of body fluid into normal and promoting vitality. Nature cure uses elements of nature –water, earth, air, fire and space and hydrotherapy is the remedy for many diseases. Gastro hepatic pack (GHP) is hydrotherapeutic methods that influence the functioning of stomach and liver. GHP is recommended for many digestive and metabolic disorders especially type 2 diabetes mellitus. OBJECTIVE: To assess the impacts of gastro hepatic pack on liver functions in patients with type 2 diabetes mellitus. MATERIALS AND METHODS: The hot water bag (98 to 104 degree F) is kept on the abdominal region, covering the epigastric region, left and right hypo gastric region, left and right lumbar region and umbilical region. The ice bag (55 TO 65 degree F) covers the region of lumbar vertebrae L1, L2, L3 and L5.The treatment is administered in supine lying position, where the hot fomentation bag is kept over the abdominal region and then ice bag on the lower back region. The patients are then covered with cotton cloth and wrapped with woolen blanket. STUDY DESIGN: Randomized Controlled Trial with sample size of 40 (20 subjects in each) were recruited in study and control group. Study group was given with 20 minutes of GHP for a duration of seven days. Control group were administered with routine Naturopathy & Yoga treatments other than GHP. RESULT & CONCLUSION: The result shows significant changes in plasma ALP, in study group than control group. GHP can be suggested for promoting liver functions in subjects with type 2 diabetes mellitus when comparing to set of other naturopathy treatments. GHP gives positive changes in plasma ALP

    Pre-clinical Evaluation of “Saaranai Ver Chooranam” for its anti-ulcer, Anti-secretory and Antacid activities: In-Vitro & In-Vivo studies

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    The drug Saaranai Ver Chooranam was selected to evaluate the safety and its efficacy for Anti-ulcer activity in animal model [Wistar albino rats]. The ingredients of the drug of Saaranai Ver Chooranam were identified and authenticated by Botanist & Gunapadam experts. The drug was prepared as per classical Siddha literary procedure and subjected to various studies to reveal the potency and efficacy of the drug. ❖ From the above studies, the Saaranai Ver Chooranamwas standardized as per PLIM guidelines. Organoleptic characters and Physico-chemical studies: The organoleptic characters and physico-chemical studies were made to standardization of the drug Saaranai Ver Chooranam reveals that ❖ Physicochemical results LOD 6.533±1.007, total ash (%) 5.067±2.055, acid insoluble ash (%) 0.05±0.0167, water soluble extractive(%) 20.47±3.356, alcohol soluble extractive (%) 8.233±1.531. solubility nature shows soluble in ethanol, water & DSMO. ❖ Phyto chemicals reported are Alkaloids, flavonoids, steroids, Coumarins, phenol, Tannin, Saponin & sugar, Heavy metal analysis falls out within BDL, There were free from viable microorganisms in Sterility test, seldom microbial growth were seen in Specific pathogen test, Pesticide residue of Organochlorine, Organophosphorous, Organocarabamates, Pyrethroids on below quantification limit, Aflatoxins are not detected. ❖ Bio-chemical test Acid radicals found are Carbonates & Chlorides and Basic radicals found are Zinc & Iron. ❖ Instrumental Analysis: FT-IR: The results reveals the sample drug SVC constitutes. It confirms that Saaranai ver chooranam constitutes Alcohols, Alkane, Aromatic Oxides, Allene, Aldehyde, Imine / oxime, Aromatic, Diaryl esters, Amine, 1-3-trisubstituted, Halo compounds functional groups.So, confirming the presence of active molecules responsible for the therapeutic activity of the drug. ❖ SEM-EDX analysis confirm the presence of Carbon, Oxygen, Chloride, Potassium, Calcium and Nickel containing compounds present in the SVC shows most of the particle present in the sample are nano size, particle size is 5 μm. The sample drug SVC proved the nano particles enhances the bio-absorbtion and bio-availability used to improve drug delivery system. The table represents the weight and atomic percentage of sample. The quantitative estimation of Carbon, Oxygen, Chloride, Potassium, Calcium and Nickel 49.49 Wt%, 44.91 Wt%, 0.31 Wt%, 2.18 Wt%, 1.30 Wt%, 1.82 Wt% respectively ❖ Toxicity studies: Toxicity studies revealed about the acute and sub-acute toxicity effect of the Saaranai Ver Chooranamin rat models. According to OECD guidelines, the haematological, biochemical parameters were investigated. Conclusively, the toxicity results revealed that the drug SVC has no signs of toxicity at 2000 mg/kg body weight of rats orally; sub-chronically. It can be concluded that the dose level of 2 gram mentioned in Siddha literature is the safety dose for human consumption. So, the drug SVC is safe and has anti - ulcer activity. ❖ Pharmacological studies: Pharmacological activity explained the efficacy of the drug and the studies were done on the rat models for Anti - ulcer, Anti – secretory and Antacid activities of the drug Saaranai ver chooranam. ❖ Anti-ulcer activity: The SVC was found to be an effective anti ulcerogenic agent, whose activity can well be compared with that of ranitidine hydrochloride. The results of this study suggest that Saaranai ver chooranam causes an inhibitory effect on release of gastric hydrochloric acid and protects gastric mucosal damage. ❖ Anti-secretory activity: The SVC showed a good anti-secretory activity in this study, which could have been due to the variations in the quality of the SVC or the use of the raw drug in this study, unlike in the other study. In Siddha, a raw drug (without extraction) is said to contain various components which work synergistically and give good effects with low side effects. ❖ Antacid activity: The duration of neutralization was found to be highest for SVC when compared to both the standards as well as Pantoprazole. This reveals that SVC is able to neutralize the acid secreted for longer time depicted its potent antacid nature. CONCLUSION: This Preclinical study was performed in In vitro & In vivo models to obtain basic information about the safety and biological efficacy of a drug “SAARANAI VER CHOORANAM” for its Anti-Ulcer, Anti-Secretory and Antacid activities. This study was performed in compliance with GLP/GSP guidelines (good laboratory practice and good scientific practices) to ensure reliability and reproducibility of result of Gastro-protective effect of SVC. An ideal anti-ulcer drug is one which not only checks acid secretion (aggressive factors) and improves mucosal resistance (cytoprotection / defensive factors) but also should promote cell regeneration (ulcer healing). All these findings of the present study indicate that SVC may offer another approach to the therapy of Peptic ulcer (acute and chronic), but extensive clinical trial could be conducted further to establish its potency in human beings. The FDA/EMA requires supporting basic preclinical data to IND application especially on toxic effects, safety profile, pharmacokinetics, and pharmacodynamics. Hence, these data prevailing from this preclinical trial- Saaranai Ver Chooranam can be accurate, reliable, and based on the best suitable and comparable model available to the target population. It is concluded that the benefits of animal research is worth to manage public health and medical research. Subsequently, animal studies are justifiable if done in a way to minimize pain in animal models and wherever applicable alternative methods are explored and avoiding unnecessary cruel treatment to animals. The guidelines to conduct quality research with respect to animal utilization criteria are clearly being demonstrated in the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Central Drugs standard Control Organization (Schedule Y), The Organization for Economic Co-operation and Development (OECD). These guidelines have been promoted to improve the standards of well-being of people around the world. So, The Preclinical research in Siddha is a Rise and daw

    A Prospective Open Labelled Non Randomized Phase II Clinical Trial on Uthiravatha Suronitham with Trial Drug Seenthil Chooranam

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    A prospective open labeled Phase II, Non- Randomized clinical trial to evaluate the efficacy of the Seenthil Choornam in treating the UTHIRAVATHA SURONITHAM. The study was conducted at Govt.Siddha Medical College & Hospital, Palayamkottai, Tirunelveli. UTHIRAVATHASURONITHAM is one among the 80 Vatha diseases according to Yugi Vaidya Chinthamani-800. It is characterized by bilateral simultaneous involvement of smaller joints of hands and feet, elbow joint, knee and ankle joints and other joints with pain and swelling, in chronic conditions resulting in deformities. There are multisystem involvements, Loco motor system gastrointestinal tract, circulatory system along with psychological disturbances also. Uthiravatha suronitham is compared to Rheumatoid arthritis in modern medicine. Seenthil Choornam is a herbo – animal drug contains, Seenthil, Karisalai and Poonagam and it is mentioned in Siddha literature Agathiyar Paripooranam -400. The collected raw drugs were purified powdered and combined as per the literature. The preclinical evaluations of Seenthil Choornam were conducted- Physicochemical evaluation, Phytochemical evaluation, Anti-oxidant activity evaluation and Antimicrobial activity evaluation. Pharmacological and Toxicity studies were included in the study. The following data were obtained from above study. The females were more prone to this diseases and the age group is mostly between 30 to 50 years i.e. during the Pitha kalam. During Pinpani kalam, Koothir Kalam and Elavenil Kaalam most of the patients have more symptoms. So the drug was administered according to their body constitution and climatic changes for getting better results. The Biochemical evaluation showed the presence of Sulphates, Chlorides and Amino acids. The Phytochemical evaluation showed the presence of Carbohydrates, Proteins, Alkaloids, Flavonoids and Saponin. The Anti-microbial activity study showed that the Aq. Extract of sample –SEC is active against both Gram positive and Gram negative bacteria- Staphylococcusaureus, Enterococcus feacalis, Bacillus Subtilis,Klebsiella Pneumonia, Pseudomonas aeruginosa and fungi-Aspergillus flavus. Anti-oxidant activity assay showed that the drug had very effective free effective free radical scavenging activity against DPPH and thus it has good Anti-oxidant property. The Pharmacological study showed that the drug have very effective Anti-inflammatory, Analgesic and Immunomodulatory activity without making any other ill effects. The toxicity study revealed that the drug dose not producesany toxic effects even in its maximum dose of 2000mg/kg body weight of animal. So it is safe for human administration. The statistical analysis showed that the P Value is less than .5, so, that the Seenthil Choornam have good efficacy in treating Seenthil Choornam

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