Vidhya, R (2018) Preclinical and open clinical trail of Gandhi Mathirai (Internal Medicine) and Sagala Ranangalukum Kalimbu (External Medicine) in the treatment of Madhumega Viranam (Diabetic Ulcer). Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The raw drugs of GM were identified and authentication certificate was obtained. The physicochemical analysis of the prepared drug revealed that it was in the standard quality. HPTLC were done to identify phyto- chemicals and their Rf values were calculated. The toxic elements like Mercury, Arsenic and Cadmium are not detected. The Lead present in GM is within the WHO permissible limit. The study shows that GM did not produce any toxic effect in repeated oral toxicity study for 90 days. This study has been approved by NIS/IEC/2016/11-15/14.10.2016. The disease diabetic ulcer was taken for the clinical study with Gandhi mathirai andSagala ranagalukum kalimbu 30 cases were selected based on the approved protocol. Animal studies were done after obtaining approval from the Animal Ethical Committee (IAEC). Hence the study was safely executed on patients and there was no adverse drug reactions noted during the study period. The detailed study on diabetic ulcer with reference to its aetiology, pathogenesis, investigations, clinical features, diagnosis and treatment with trial drug was done. According to BJWAT scoring, before treatment 28 patients were score between the no on 27-52 and 2 patients were score between 53-65.After treatment 15 patients was score 13,10 patients were scored 14-26,5 patients were scored 27-52. The results were observed by BJWAT score. Among the 30 cases treated, 15(50%) cases showed Good improvement, 7(23.4%) cases showed Moderate improvement and 8(26.6%) cases showed Poor improvement. The mean± standard error of mean of BJWAT score at before and after treatment were 39.93 ± 8.072 and 18.66±7.288 respectively which is statistically significant (t= 11.9576, p <0.0001). CONCLUSION: The herbo-mineral formulation Gandhi mathirai (GM) exhibited no toxicity on Repeated 90 days toxicity study. The present clinical study confirms the efficacy and safety of the trial drug “Gandhi mathirai” which is Siddha herbo-mineralformulation. It was found to be good resulting on Madhumega viranam patients in reducing clinical signs and symptoms like ulcer with and without pain, oozing present, foul smell, numbness foot, burning sensation. The quantitative outcome of BATES JENSAN WOUND ASSESSMENT score shows there is significant reduction between at the start and end of treatment i.e from 39.93 ± 8.072 and 18.66±7.288. The qualitative outcome shows there is 50% of cases had shown good improvement, 23.4% of cases had shown moderate improvement and remaining 26.6% of cases had shown poor improvement. According to BJWAT scoring, before treatment 28 patients were score between the no on 27-52 and 2 patients were score between 53-65. After treatment 15 patients was score 13,10 patients were scored 14-26,5 patients were scored 27-52. From the above results, the trail drug “Gandhi mathirai” was responded well in the treatment of Madhumega viranam. As a conclusion it can be stated that the Siddha herbo-mineral formulation GM can be used as a safe and efficacious drug towards the management of Madhumega viranam.
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | Preclinical and open clinical trail ; Gandhi Mathirai ; Sagala Ranangalukum Kalimbu ; treatment ; Madhumega Viranam ; Diabetic Ulcer. |
| Subjects: | AYUSH > Sirappu Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 29 Dec 2018 11:11 |
| Last Modified: | 29 Dec 2018 11:11 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/10260 |
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