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Preclinical Evaluation of Siddha Poly-Herbal Formulation Thirinethira Chooranam for its Possible Impact on Iron Deficiency Anemia through Hematinic, Anti-Oxidant activities and Estimation of Erythrocyte Cholinesterase activity in In vivo and In vitro Studies
No full textIron Deficiency Anemia is an important health issue in the global population, affecting every ethnic group and social strata. The present pre-clinical study was performed to evaluate the safety and efficacy of the Siddha formulation "Thirinethira Chooranam" in treating iron deficiency anaemia through hematinic, antioxidant activities and estimation of erythrocyte cholinesterase activity in in-vivo and in-vitro studies.
◉ The main obstacle in Siddha system of medicine in modern medical practice is the lack of scientific and clinical data and a better understanding of the efficacy and safety of herbal, metal and mineral drugs.
◉ In order to overcome this difficulty a novel attempt has been made to standardize and evaluate the Siddha drug “THIRINETHIRA CHOORANAM” for its Hematinic property by using analytical and preclinical studies.
◉ The drug “THIRINETHIRA CHOORANAM” was selected from the Siddha literature “Koshaye Anuboga Vaithiya Bramma Ragasiyam – part-2”.
◉ The ingredients of the test drug were identified and authenticated by the Botanist and by the Gunapadam experts, GSMC, Chennai. The drug was prepared as per classical Siddha literary procedure and subjected to various studies to reveal the potency and efficacy of the drug.
◉ The procedure of drug preparation and its techniques for standardization revealed GMP. The trial drug THC has satisfied all parameters of testing protocol for Chooranam which was assigned by PLIM.
◉ Various analysis such as Organoleptic character, Physiochemical analysis, Test for Sterility, Specific Pathogen, Pesticide residue, Aflatoxins, Phytochemical, Biochemical analysis, Instrumental analysis were done.
❖ Organoleptic characters:
The organoleptic character of the drug THC showed the solid, pale brownish colour. The fineness of the Chooranam represents easy absorption and better availability of the drug. Particle size determination confirms that the test drug THC is fine powder with average particle size of 30.18 μm. Solubility, processing properties, bioavailability, product uniformity, stability and therapeutic efficiency are affected by particle size.
❖ Solubility:
The physical character of THC is well soluble in major like solvents water, ethanol and DMSO. Thereby it proves its efficiency of solubility and increasing in bio- availability in the stomach indirectly.
❖Physicochemical analysis:
Physicochemical analysis of THC proves that the drug has a longer self- life and the drug is standard and pure.
❖ Phytochemical analysis:
HPTLC finger printing analysis of the sample reveals the presence of seven eminent modes relevant to presence of seven different phytocomponents present with in it. Rf value of the peaks ranges from 0.01 to 0.85.
❖ Biochemical analysis:
Biochemical analysis showed the presence of iron, Magnesium, carbonates, phospates and Sulphides.
❖ Microbial test:
The sterility test showed no growth/colonies were observed in any of the plates inoculates with the test sample THC. This revealed that the drug THC are free from the viable microorganisms and the absence of total bacterial and fungal count which may indicate that the drug THC’s quality and safety.
❖ Specific Pathogen Test:
No growth / colonies were observed in any of the plates of inoculated with the test sample THC indicates that the test drug is sterile and free from E.coli, Salmonella, Staphylococcus Aureus and Staphylococcus Aureus.
❖ Pesticidal Residue Test:
The result showed that there were no traces of pesticides residues such as organochlorine, organophosphorous and pyrethroids in the sample provided for analysis. So the drug THC has no toxicity, slow degradation and bioaccumulation.
❖ Aflatoxins Test:
The result showed that there were no spots being identified in the test sample loaded TLC plates when compare to the standard, so the drug THC is non-toxic and there is no contamination.
❖ Heavy metal analysis:
Results of the present investigation have clearly reveals that the sample THC has only Below Detective Level of heavy metals such as Arsenic, Mercury, Lead and Cadmium and safe for consumption.
❖ FT-IR:
The result reveals the sample drug THC constitutes Amide, aldehyde, carboxylic acid, nitrile group, nitroso, alkyl and methylene groups as functional groups. So, confirming the presence of active molecules responsible for the therapeutic activity of the drug.
❖ SEM:
Scanning Electron Microscopy determines the elements present in THC that are Carbon, Oxygen, Iron, Sodium, Magnesium, Silicon, Chloride, Potassium and calcium and reveals the average particle size as 30.18 μm.
❖ Toxicity studies:
From the acute toxicity study as per OECD guideline 423, it was concluded that the test drug Thirinethira Chooranam is a safest drug. No mortality was obtained.
Toxicological study of both acute and sub-acute toxicity study was carried out in animal model Wistar rat according to the OECD guidelines. The test drug showed no acute toxicity as there was no mortality seen. The sub-acute toxicity after the repeated dose of 28 days was done. The mortality, functional observations, haematological and biochemical investigations were made. There was no significant change seen in the normal values. Thus, the toxicological study of the test drug greatly establishes the safety and gives the justification for long time administration.
❖ Pharmacological activities:
The pharmacological study was carried out in the animal model rats and in vitro.
1. Hematinic activity against Desferrioxamine induced Iron Deficiency anemia,
2. Anti-oxidant activity –DPPH Assay,
3. Erythrocyte Cholinesterase Activity.
1. Hematinic Activity:
Desferrioxamine treated negative control group haemoglobin level is 8.9g/dl and the high dose (400mg) test drug treated group haemoglobin level is 16.6 g/dl. Hence there is a significant raise in the haemoglobin level in test drug treated group when compared with negative control group.
2. Anti-oxidant activity:
It is revealed the significant DPPH radical scavenging activity was observed at the concentration 200, 400 and 600μg/ml. Lower dose of drug concentration such as 50 and 100μg/ml did not show any significant change inhibition. THC extract has significant level of anti-oxidant activity at higher concentrations.
3. Erythrocyte Cholinesterase Activity
THC administrated both groups 200mg, 400mg shows enhanced RBC ChE Activity which an indicator of erythropoiesis. The increase in RBC ChE activity to above normal level following therapy as many new cells are released into the circulation, shifting the cell population to predominantly younger erythrocytes.
Thus by scrutinizing all the above mentioned factors it is concluded that the trial drug Thirinethira Chooranam is a safe, potent Hematinic and Antioxidant.
CONCLUSION:
Today scientific world focused on herbal preparation for various ailments because of its synergistic effects, less adverse reaction and anti-oxidant properties. Although Siddha Medicines are traditionally used by people for its potential therapeutic values, data on drug’s safety and efficacy is necessary to recognize Siddha medicines as evidence based by modern scientific world. Hence this study is aimed to ensure safety and efficacy of Thirinethira Chooranam through modern pharamaceutical analytical techniques and pharmacological studies. The study it is concluded that trial drug Siddha Poly-herbal formulation “Thirinethira Chooranam” is potent hematinic and anti-oxidant. It is safe and efficacious in treating Paandu (Iron Deficiency Anemia) and it would be a great drug of choice. Drug and food interaction studies and clinical trials have to be carried to elaborately understand pharmacokinetics and pharmacodynamics of Thirinethira Chooranam.
Oral iron preparations have side effects like metallic taste, temporary staining of teeth enamel as well as gastrointestinal symptoms such as nausea, vomiting, abdominal pain, flatulence, constipation, and dark stools. But Thirinethira Chooranam has no side effects and so it would be a best drug of choice without side effects
Clinical Evaluation of the Effect of Akkara Nei for the treatment of Vaai Akkaram
Get PDFVAAI AKKARAM is the most common oral diseases in pediatrics. The signs and symptoms of the akkaram may be correlated with the stomatitis in modern system of medicine. It is inflammation of the mucosa of the oral cavity, usually don't need treatment and will clear up within a week. If not treated it may leads to serious illness such as anaemia, dermatitis and diarrhea etc. Stomatitis is a condition with presenting symptoms of swelling and redness inside the mouth, or individual painful sores that make uncomfortable for a person to eat, Fever, swelling and ulceration over the oral cavity, or blister in the mouth, Dysgeusia. In this study, 22 cases were treated in the outpatient department and 18 cases were treated in the inpatient department and treated with AKKARA NEI which has been mentioned in the siddha literature PARARASASEEGARAM. The ingredients of this medicine are purely herbal as it is safe and have good efficacy in treating Vaai akkaram in children.The diagnosis is based on clinical observation and laboratory investigations. Under the diagnostic criteria the patients are treated with the drug AKKARA NEI and the efficacy of the drugs and the improvements of the patients are clearly observed.
The drugs which are mentioned in the siddha literature for the management of Vaai akkaram were selected and the study is conducted after the proposal was screened by the Screening committee. The clinical study has been approved by IEC approval(……..). The trial is registered in clinical trial Registry of India with Reg.No.CTRI /2020/12/038740.The authentication of ingredients of the trial drug was obtained from Department of Gunapadam, GSMC, Palayamkottai.
The drugs which are mentioned in the siddha literature for the management of Vaai akkaram were selected and the study is conducted after the proposal was screened by the Screening committee. The clinical study has been approved by IEC approval(……..). The trial is registered in clinical trial Registry of india with Reg.No.CTRI /2020/12/038740.The authentication of ingredients of the trial drug was obtained from Department of Gunapadam, GSMC, Palayamkottai.
Physicochemical evaluation of the trial dug was done as a preliminary analysis. The refractive index is a measure of purity of a sample. It is a ratio of velocity of light in vacuum.If any adulteration present in the sample the refractive index will increase or decrease, helpful in determination of unsaturation.Since the refractive index is 1.88, it interprets that there is no adulteration and degree of unsaturation is low. Iodine value, Saponification value were used to measure the relative degree of unsaturated fatty acid in the sample.The saponification value indicates the mean molecular weight of fatty acid of triglycerides comprising of fat. The iodine value (mg12/g) is 76.84 and saponification value (mg of KOH to saponify 1 gm of fat) is
177.63. The observation shows medium chain fatty acid or triglyceride as the main component.
The trial drug also free from Heavy metals, Aflatoxin, Microbial contamination and pesticide residues. So it is safely administered to paediatric cases.
The phytochemical of the trial drug consists of Sulphate, Chloride, Starch, Tannic acid, Unsaturated compounds, Aminoacid.
Animal studies were carried out after obtaining proper permission from the Institutional Animal Ethical Committee (IAEC).The Institutional Animal Ethical Committee Approval No was SARPC/IAEC/27/2021. The Anti inflammatory and Anti pyretic activity of the trial drug akkara nei was carried out in S.A.Raja's Pharmacy College, Vadakangulam, Nagarkovil.
In clinical studies the patient were recruited for the trial based on inclusion and exclusion criteria and after getting the consent form from the patient.40 patients were included in the study. 22 patients were treated as Out patient department and 18 cases were treated as Inpatient ward of GSMC,Palayamkottai. Sepaerate proforma was maintained for every patient.
The patients were treated with trial drug Akkara nei for 10 days. Patients were instructed to take the medicines regularly and advised to follow up.The results observed during the study period were discussed below. This study elicies the efficacy of Akkara nei in relieving the symptoms of Vaai akkaram.
CONCLUSION:
In the present study the trial drug AKKARA NEI was treated to the children of age group 3 to 12 years. 22 patients from OPD and 18 patients from IPD were treated with Akkara Nei for 10 days twice a day with a disease vaai akkaram. The ingredients of the trial drug are easily available and very much Affordable to all people.
The trial medicine has many phytoconstituents and phytochemicals to relieve the signs and symptoms of the disease. The trial drug possess Anti inflammatory and Anti pyretic activity. Clinical results were found to be Significantly good improvement in 65% of cases, moderately in 27.5% of cases. During the course of treatment, no adverse effects were observed
Phase II Non Randomized Clinical study on Kana Mantham (Gastroenteritis) with the Evaluation of Siddha Trial Drug “Kana Mantha Mathirai” in Children
No full textClinical Evaluation and Therapeutic Management of Manthasanni (Autism Spectrum Disorder) by Uthaamani Nei (Internal) along with Nellikkai Thylam (External)
No full textA Prospective Open Labelled Non Randomized Phase II Clinical Trial on Mavilingapattai Kudineer in the Management of Thandagavatham (Lumbar Spondylosis)
No full textSiddha is a Tamil word derived from “Siddhi”, attaining perfection in life or heavenly bliss. It is exclusively linked with Tamil culture and civilization. The Siddha medicine system diet and lifestyle play a major role in health and curing disease. The Siddha system is one of the oldest medicinal system which is primarily give importance in treating disease with natural medicines. Also, the concept of treatment of disease using simple herbal medicines at first and if the disease is not get cured physician can opt higher metalic and mineral medicine. And takings this concept into consideration I had selected the trial drug Mavilingapattai kudineer for treating Thandagavatham. As per Yugi munivar, thandagavatham is one of the 80 types of vatham. The disease Thandavatham can be correlated in modern medicine with lumbar spondylosis Lumbar spondylosis is a degenerative disease affecting the intervertebral discs, vertebral bodies and assiociated joints of lumbar spine. Bad posture plays a very significant role in the genesis of the disease. Aim of the study is to evaluvating the therapeutic efficacy of “Mavilingapattai kudineer” in the management of “Thandagavatham”. The study is conducted at Government siddha medical college Palyamkottai for 18 months. Study is conducted strictly according to the instructions of guide & supervisior. The raw drug is identified and authenticate before the pre clinical study. The instutional ethical committee approval has obtained prior to the study. The patients allotted according to inclusion and exclusion criteria.
In this preclinical study analysis the biochemical cibstituents and phyto constituents present in the mavilingapatti kudineer are identified.The pharamacological and toxicity study were also done, studies are conducted. After the approval of institutional animal ethical committee. The biiochemical analysis shows the presence of constitents like starch, calcium,chloride etc, and phytochemical studies proofed the presence of alkaloids, terpenoids, phenols. Pharmacological and toxicity tells about the trial medicine “Mavilingapattai kudineer” as a good anti inflammatory, analgesic and no adverse effect recorded. The toxicological study of this trial drug establish the safety of the drug. These findings will give valuable information for the future studies
Preclinical Safety Evaluation of Vajrakandi Mathirai
No full textThe test drug Vajrakandi mathirai consists of Lingam, Rasa chenduram, Veeram, Pooram and extract of Lime and Ginger which was adopted from the text Anuboga vaithiya Navaneetham Part 5. The aim of the research work was to study the safety of Vajrakandi mathirai by acute and Repeated dose 28 days’ oral toxicity study in the wistar rat as per OECD Guidelines
❖ The Standardization procedures such as organoleptic characters, Physicochemical analysis and biochemical analysis were analyzed primarily.
❖ The physicochemical analysis of the test drug showed the increased bioavailability and purity of the drug.
❖ The disintegration time of Vajrakandi mathirai is 33 minutes (Normal range is below12 minutes). As per results the disintegration time is high but it become not significant when it is taken as powder form along with honey.
❖ Qualitative analysis showed the presence of Calcium, Phosphate, Chloride, sulphate, iron in Vajrakandi mathirai. ❖ Result of HR-SEM showed , Most of the particles were very tiny, unarranged and irregular in shape with amorphous in nature.
❖ The SEM with EDAX report showed the presence of Carbon, Oxygen, Sulphur, Chlorine, Mercury, in different proportions
❖ ICP-OES result showed that the presence of 21.02 μg/g of Copper, 2.48 μg/g of Manganese, 153.3 μg/g of Ferrous iron, 774.8 μg/g of Potassium,80 μg/g of Lead, 83.9 μg/g of Magnesium, 1.99 %w/w of Mercury, 1.36%w/w of Arsenic in Vajrakandi mathirai
❖ Acute toxicity study of Vajrakandi mathirai showed no abnormal signs at the dose level of 2000 mg / Kg b.wt. No mortality, morbidity and pathological changes have been seen in internal organs of treated groups during the study period.
❖ Repeated dose 28 days’ oral toxicity study results did not reveal any behavioral changes, mortality and morbidity. The body weight, feed intake and water intake of all the animals were gradually increased during the study period.
❖ Hematological parameters of all the test animals were normal and did not show any changes when compared with control group. Bio-chemical analysis of all animals were normal.
❖ Histopathological examination of internal organs did not show any abnormalities in all test drug treated animals.
❖ So, it is observed that the test drug does not cause any damage to the tissues and thus the safety of drug is proved.
CONCLUSION:
Vajrakandi mathirai was taken as a test drug, the quality parameters and safety profile of the drug were analyzed as per standard protocol. The qualitative and quantitative analysis of Vajrakandi mathirai proved the quality and purity of the drug. The quality assessment results will be used as standard for future research on Vajrakandi mathirai. The Acute toxicity study results did not show any mortality, behavioral changes and drug related toxicity. From the Acute toxicity study, it is revealed that Vajrakandi mathirai is not toxic at a maximum oral dose level of 2000 mg/kg in Wistar rats. So, the maximum tolerable dose (MTD) of Vajrakandi mathirai is greater than 2000 mg / Kg b.wt. In Repeated Dose 28 Days oral toxicity study, haematological and biochemical parameters of 250mg/kg b.wt test drug treated animals were within normal limit and histopathological parameters showed no significant changes in internal organs compared with the control group. So, the No Observed Adverse Effect Level (NOAEL) of Vajrakandi mathirai is greater than 250mg/kg.b.wt. Hence, the safety of Vajrakandi mathirai is proved through this study. From the study results, it is concluded that the therapeutic dose of Vajrakandi mathirai 130-195mg (1- 1 1/2 Kundri) is safe for human consumption. Further clinical trials, Pharmacological studies and efficacy studies will be carried out on Vajrakandi mathirai to prove the efficacy of drug
A Clinical Study to Evaluate the Efficacy of Ilaikkalli Ilai Pugai in the treatment of Pura Moolam
No full text40 cases with pura moolam was diagnosed clinically based on yugi 800 and admitted in the inpatient ward and outpatient ward of post graduate department of Pura maruthuvam, Government Siddha Medical College & Hospital, Palayamkottai and treated by the trial medicines.
➢ Laboratory diagnosis of pura moolam was done by siddha diagnostic principles and endorsed by modern methods of investigations.
➢ The various siddha aspects of examination of the disease were carried out and were recorded in the proforma.
➢ The trial medicine ILAIKALLI ILAI PUGAI chosen for EXTERNAL THERAPY.
➢ Before starting the treatment careful detailed history was carried out and recorded for the forty selected cases.
➢ During the period of treatment all the patients were put under pathiyam (A specific dietary regimen).
➢ A periodical laboratory investigation was made for all the cases.
➢ The observations made during the clinical study shows that the ilaikalli ilai pugai is clinically effective.
CONCLUSION
The disease puramoolam was taken for the clinical study with reference in yugi Vaidhya Chinthamani – 800.
The aetiology, pathology, pathogenesis, clinical features and prognosis of the disease were collected from a number of literatures both in siddha system as well as in modern system of medicine.
All 40 patients were treated for this dissertation work in ilaikalli ilai pugai (External Therapy).
The overall effects of the External Therapy are
Marked effect - 30%,
Moderate effect - 37.5%,
Mild effect - 27.5%,
No improvement - 5%.
The result of the clinical trial illustrates the marked effect of the external therapy.
The clinical study shows significant decrease in the symptoms of the disease. The trial drug ilaikalli ilai pugai (external therapy) gives a good confidence in the management of puramoolam and economically very low cost.
Along with the trial drug supportive therapies like diet and lifestyle changes may control the disease.
No adverse effects were noticed during the treatment period.
Finally concluded that the external therapy (pugai) is effective treatment for puramoolam.
External therapies can be done in major measure with locally available resources and therefore is accessible and affordable to the entire society. It is the emblem of our siddha system. There are occasions where the administration of oral drug impossible and hence to review the patients administration of drugs and manipulate through the external therapies. Another researches must be done to list out various goodness of the external therapies in our siddha system
A Cross Sectional study on Changes in the Iris of the Patients with Uterine Fibroids
Get PDFBACKGROUND:
Uterine fibroids (myomas or leiomyomas) [UF] are benign, monoclonal tumors of the uterine smooth muscle cells. Abnormal bleeding, pelvic masses, pelvic pain, infertility, bulk symptoms, and obstetric complications are some of the clinical manifestations. Due to symptoms, nearly one-third of women with leiomyomas will seek treatment. Rates of inpatient hospitalization for UF in the United States increased steadily by age from 1998 to 2005, peaking among women aged 45–49 years (6.3 per 1,000 person-years). People today require preventative health care and less difficult techniques for assessing their health. Iridology is a noninvasive, painless, and cost-effective method of checking into the body that can be used in conjunction with any other diagnostic technique. However, no known study has reported changes in the iris in uterine fibroid patients.
METHODS:
This observational cross-sectional study was carried out among 60 females aged 30 to 55 years. An interactive introductory lecture about the purpose of the study was explained to the subjects. After obtaining the written consent, they were subjected to detailed history taking, and their iris images were captured and documented using a 12 MP iridology camera with pro-iris software.
RESULTS AND CONCLUSION:
This study revealed that the iris changes in the uterine area of the right iris is about 83.33% and left iris is 60%, concluding that iris diagnosis can be a pre-diagnostic tool in the diagnosis of uterine fibroids
Immediate Effects of Trataka on Autonomic Function in Healthy Volunteers: A Randomized Controlled study
Get PDFBACKGROUND: Glaucoma is the leading cause of irreversible blindness in many countries and can affect the quality of life with moderate to severe loss. This study is to evaluate the effect of selected Yogasanas on Intraocular pressure (IOP).
METHODS: A total of 100 subjects aged 21.20±2.69 years were randomly assigned into 5 asana group after satisfying inclusion and exclusion criteria. Ushtrasana (n=20), Sedhubandhasana (n=20), Dhanurasana (n=20), Shalabhasana (n=20), & Ardha Chakrasana (n=20). All 5 asana group assessed at baseline IOP, then given intervention for 30 seconds, post IOP taken with immediately after intervention and followup IOP after 2min relaxation are taken for analysis. The tonometer used to assess IOP in this study is Topcon CT-80 non-contact tonometer.All the 100 subjects completed the study successfully.
RESULTS: The study showed no significant changes between the group Analysis. However significant reduction of IOP in left eye was seen in Dhanurasana and Sedhubandhasana immediately after the practice, Ushtrasana showed significant reduction of IOP in left eye after 2 minutes of practice and ardha chakrasana showed significant reduction of IOP in right eye after 2 minutes of practice.
CONCLUSION: Among selected 5 asana practice Dhanurasana, Sedubandasana, Ushtrasana and Ardha chakrasana showed significant reduction in IOP. Whereas there is no significant changes observed in Shalabhasana
The Immediate Effect of Parivrtta Trikonansana on Blood Glucose Level in Type II Diabetics
Get PDFBACKGROUND: Diabetes mellitus is a group of metabolic disorders characterized by hyperglycemia resulting from defects in insulin secretions, insulin action, or both. There are reports as regards to the influence of group of asana on blood glucose levels. However, to the best of our knowledge there are no studies evaluated the effects of single asana i.e. Parivrtta trikonasana on blood glucose levels in type 2 diabetes mellitus (T2DM). Thus, the present study was conducted to evaluate the effect of Parivrtta trikonasana on random blood glucose (RBG) levels in patients with T2DM.
METHODS: A total of 100 subject with T2DM were included in the study. All the subjects underwent a single session of intervention. The Yoga Group (YG) underwent Parivrtta trikonasana and Control Group (CG) under simple sitting for 05 mins. Baseline and post-test assessments of RBG levels were measured just before and immediately after each intervention. Statistical analysis was performed using statistical package for the social sciences, version 16. P value <0.05 was considered as significant.
RESULTS: There is a significant reduction in RBG levels in the YG compared with the CG.
CONCLUSION: The Results of the present study demonstrated that the practice of Parivrtta trikonasana is effective in reducing the blood glucose levels in patients with T2DM