Vignesh Kumar, K (2022) A Randomized Control Trial on the Therapeutic Effect of Siddha Herbo–Mineral Preparation Naaga Chendooram in the Treatment of Madhumega Avathai VII - (Diabetic Peripheral Neuropathy): A Complication of Non-Insulin-Dependent (Type II) Diabetes Mellitus. Masters thesis, National Institute of Siddha, Chennai.
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Abstract
The aim of the study to the therapeutic efficacy of Siddha herbal formulation “Naaga Chendooram” in Madhumega Avathai VII -Diabetic peripheral neuropathy in (Type 2) Diabetes Mellitus patients. ❖ The study protocol was prepared and submitted before the Institutional Ethical Committee (IEC) of the National Institute of Siddha. The date of IEC approval & IEC number is [21-12-2020; NIS/IEC/2020/D8]. ❖ The trial was registered in the Clinical Trial Registry of India with Reg.no CTRI/2021/07/035067 (Registered on date:22 /07/2021). ❖ The raw drug was authenticated by the Botanist, National Institute of Siddha, Chennai -600 047. ❖ The Siddha herbal formulation “Naaga Chendooram’’ was prepared as per the standard operating procedure mentioned in the Gunapadam laboratory, NIS, under the supervision of the guide. ❖ Organoleptic characterization physicochemical Analysis, heavy metal analysis. Scanning Electron Microscopy (SEM) with Energy Dispersive X-ray analysis (EDAX) and Anti-diabetic activity of the trial drug was carried out. ❖ In the cases with the complaints of clinical parameters, the MNSI scale was screening proforma, for Madhumegam Avathai – VII. ❖ Among the 274 cases screened, 151 cases were males and 113 cases were female of which 80 cases of Madhumega Avathai –VII were diagnosed clinically and were Simple Randomization in each group of 40 patients. ❖ In this study the trial drug Naaga Chendooram along with Madumega choronam for a period of 90 days were given to group A. Standard drug(control) Madhumega choronam was alone given to group B the standard drug for period of 90 days in OPD Dept. of Maruthuvam, Ayothidoss Pandithar Hospital, National Institute of Siddha Chennai – 600 047. ❖ There was no serious adverse reaction noted during treatment period in both the treatment groups. ❖ Michigan neuropathy screening instrument (MNSI)–Examination and Questionnaires Routine Hematological, Biochemistry, urine examination and Siddha Systemic Clinical assessments were done before and after treatment. ❖ MNSI -Examination and Questionnaires, HbA1c, Blood sugar (F) and (PP), were done before and after treatment. Statistical Analyses were done after treatment. ❖ This Trial showed that Group A 38 cases (95%) showed good control by a decrease of more than 2% in HbA1c level and 2 cases (5%) showed moderate control. Group B 26 cases (65%) showed good control by a decrease of > 2% in HbA1c level and 14 cases (35%) showed moderate control. ❖ This Trial showed that group A among 40 cases, MNSI Examination score was decreased all the 40 cases (100 %) from its base level score. group B among 40 cases, MNSI Examination score was decreased in 32 cases (80 %) decreased from its base level and it was increased in 2 cases (5%). There was No change from its base level in 6 cases (15 %). ❖ This Trial showed that group A among 40 cases, MNSI Questionnaires score was decreased in all 40 cases (100 %) from its base level score. group B among 40 cases, MNSI Questionnaires score was decreased 36 cases (90 %) from its base level and it was increased in 1 case (2.5%) from its base level score. There No change from its base level in 3 cases (7.5 %). ❖ The clinical and laboratory observations and statistical analysis in the Madhumega Avathai – VII, cases treated with the trial drug Group A showed significant control in their blood glucose level and other parameters improvement in their general health compared to Group B patients. ❖ There is a statistically significant (p < 0.05) difference between the median values in HbA1c, MNSI – Examination score, MNSI –Questionnaires, Blood Sugar Fasting and Postprandial. On different treatment (Group A & Group B) methods. ❖ Therefore, comparing the average of both groups Group, A has an extremely significant reduction in mean compared to Group B thus Group A was extremely significant compared to group B. CONCLUSION: This Clinical trial revealed that the trial drug had good control in Group A 38 cases (95%) showed good control by a decrease of more than 2% in HbA1c level and 2 cases (5%) showed moderate control. In Group B Group B 26 cases (65%) showed good control by a decrease of > 2% in HbA1c level and 14 cases (35%) showed moderate control. In group A, among 40 cases, MNSI Examination score was decreased in all the 40 cases (100 %) from its base level score.In group B, among 40 cases, MNSI Examination score was decreased in 32 cases (80 %) decreased from its base level and it was increased in 2 cases (5%). There was No change from its base level in 6 cases (15 %). In group A, among 40 cases, MNSI Questionnaires score was decreased in all the 40 cases (100 %) from its base level score.In group B, among 40 cases, MNSI Questionnaires score was decreased in 36 cases (90 %) from its base level and it was increased in 1 case (2.5%) from its base level score. There No change from its base level in 3 cases (7.5 %). The average HbA1c for Group A at the start of treatment was 9.60 and 6.85 (p<0.001**) at end of treatment, in Group B the average was 9.95 and 7.87 (p<0.001**). It found that group A was highly significant compared to group B. The average MNSI examination score for group A before treatment was 3.03 and 2.08 (p<0.001**) at end of treatment, in group B the average was 3.36 and 2.57(p<0.001**). It was found that group A was highly significant compared to group B. The average MNSI Questionnaires score for group A before treatment was 10.77 and 5.859(p<0.001**) at end of treatment, in group B the average was 11.3 and 7.45 (p<0.001**). It was found that group A was highly significant compared to group B, by comparing the moderate reduction of MNSI - examination and questionaries’ score group A shows a significant reduction compared to group B. It is concluded by this randomized clinical trial that Naaga Chendooram is safe, efficacious, cost-effective and a potent Siddha Herbo -Mineral formulation for the long-term treatment of diabetic peripheral neuropathy of Madumega Avathai - VII. The hopeful results of the clinical trial in both clinical and laboratory investigations covered the way for future double-blinded multicenter studies.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg.No.321911208 |
| Uncontrolled Keywords: | Randomized Control Trial, Therapeutic Effect, Siddha Herbo–Mineral Preparation, Naaga Chendooram, Treatment, Madhumega Avathai VII, Diabetic Peripheral Neuropathy, Non-Insulin-Dependent (Type II) Diabetes Mellitus. |
| Subjects: | AYUSH > Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 07:46 |
| Last Modified: | 14 Feb 2024 01:55 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21145 |
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