Suresh, K (2016) Evaluation of Safety and Efficacy of Thaalisaathi Chooranam (TSC): A Siddha Formulation in Experimental Animal Models. Doctoral thesis, The Tamilnadu Dr. M.G.R. Medical University, Chennai.
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Abstract
Thaalisaathi chooranam (TSC) is a poly herbal formulation mentioned in Sasthric Siddha text Siddha Vaidhya Thirattu, which is very popular medicine and prescribed by every Siddha physican for Common respiratory problems of children and adults. • From extensive literature review and survey, TSC has been selected as a research subject by getting research guidance from the Guide. • Ingredients of the study drugs were procured from reputed shops available in the city and all of them were authenticated by Medicinal botanist of , National Institute of Siddha by evaluating the organoleptic characters of every ingredients (28 totally). • Physico chemical analysis was done as recommended by guidelines “Testing protocols for ASU Medicine”, PLIM Ghaziabad. • Preliminary phytochemical screening was done on TSC and showen that the presence of Alkaloids, Flavonoids, Essential oils, Steroids, Cardiac glycosides and tannins. Athraquinone glycosides are not present in TSC. • Identification marker tests like TLC/HPTLC studies were done showed presence of Alkaloid, Flavonoids and essential oils in this study drug TSC. • X.R.F. analysis showed that, Thaalisaathi chooranam (TSC) having important elements oxide forms like Ca (97.39%), Si(0.94%) and Oxides like CaO(95.62%) and SiO(2.02%) in major concentrations and elements like Na, Sr, Fe, Cl, Al, S, mg are present in minor concentrations • The toxic/heavy metals like Lead, Arsenic, Cadmium are not detectable in ICP-OES analysis and Mercury particles found below the WHO permissible limit. • Test for Microbial load has revealed that Total bacterial count and Total fungal count of Thaalisaathi chooranam (TSC) is below the AYUSH guidelines. There is no evidence of contamination of specific pathogen like E. Coli, Salmonella, Staph. aureus, Pseudomonas auruginosa. • Limit test for pesticides reveals that there is no evidence of Organochlorine, Organophosphorus and Pyrethroids contamination in this study drug TSC. • Test for Aflatoxins like B1, B2, G1, G2 have been done and this drug and it is free from such type of carcinogenic toxins. • FTIR instrumental analysis was done to identity the spectrum peaks of the molecules. Thaalisaathi chooranam (TSC) showed 14 peaks. Among them, 8 peaks were medium in nature. Six peaks were very strong and sharp viz… Primary amine or amide (N-H group) at wave number 3321.78 cm-1, with doublet peak. Carboxylic acid (O-H group) at wave number 2824.52 cm-1. Amides, Ketones, Aldehydes, Carboxylic acid and esters (C=O goup) at wave number 1708.62 cm-1, Alkene, Aromatic ring (C=C group) at wave number 1618.95 cm- 1, Alkulhallides (Haloalkanes) (C-F group) at wave number 1044.26 cm-1, Alken (=C-H group) with strong peak at wave number 994.125 cm-1. • Acute toxicity study of TSC with O.E.C.D. TG 423 it was observed that administration of Thaalisaathi chooranam (TSC) at a dose of 2000 mg/kg body weight to the rats do not produce any drug-related toxicity and mortality. Mortality was not observed in any treatment groups. So No-Observed-Adverse-Effect- Level (NOAEL) of Thaalisaathi chooranam (TSC) is 2000 mg/kg. • Sub acute toxicity study (28 days) of TSC was done as per O.E.C.D. 407 TG, its found that signs of toxicity were observed in animals from different dose groups during the dosing period of 28 days. Animals from all the treated dose groups exhibited comparable body weight gain with that of controls throughout the dosing period of 28 days. Haematological analysis conducted at the end of the dosing period on day 29, revealed no abnormalities attributable to the treatment. Organ weight data was ibtained by sacrificed at the end of the dosing period and was found to be comparable with that of respective controls. Histopathological examination revealed normal architecture in comparison with control and treated animalover a period of 28 days. The study results have demonstrated that the TSC is relatively safe from the dose level of 72 to 720 mg/kg body weight when administered orally in rats. • Efficacy studies related with common respiratory problems showed that TSC having good Anti allergic as evidenced by the inhibition of milk induced leucocytosis in mice and histamine induced bronchospasm in guinea pigs. TSC also having good Bronchodialator, Anti inflammatory, Immuno modulatory, Anti pyretic activity in experimental animal models. • Anti microbial studies showd that, ethanol extracts of Thaalisaathi chooranam (TSC) having significant anti-microbial activity against Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and B. subtilis. The safety and efficacy studies of Thaalisaathi chooranam (TSC) revealed that, the study drug was found to be safe and possess efficacy against symptoms of common respiratory problems. Hence this poly herbal Siddha formulation will be very useful in the treatment of frequently affecting Respiratory problems like common cold, bronchitis, childhood asthma and fever in Children. Therefore this formulation will be a worthy entity to take up for its clinical efficacy in human subjects by a randomized clinical trial. RECOMMENDATIONS: As concluded by the results of this research work entitled “Evaluation of Safety and Efficacy of Thaalisaathi chooranam (TSC), A Siddha formulation in experimental animal models”, the author recommends that, this study drug can be taken for clinical trial in human subject to establish further add on to this wonderful formulation.
| Item Type: | Thesis (Doctoral) |
|---|---|
| Uncontrolled Keywords: | Evaluation, Safety, Efficacy, Thaalisaathi Chooranam (TSC), Siddha Formulation, Experimental Animal Models. |
| Subjects: | AYUSH > Kuzhanthai Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 22 Jan 2022 06:10 |
| Last Modified: | 22 Jan 2022 06:10 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/19052 |
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