Clinical study on siddha medicine in the management of Madhumegam (Type II Diabetes Mellitus)

Ravi, K (2015) Clinical study on siddha medicine in the management of Madhumegam (Type II Diabetes Mellitus). Masters thesis, National Institute of Siddha, Chennai.

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Abstract

Herbs and herbal formulations used in traditional medicines in Siddha have been widely accepted in India as good therapeutical agents with lower side effects particularly in the management of Diabetes mellitus, a metabolic disorder which is growing exponentially at an alarming rate. But there exist lacuna in these traditional medicines such as lack of standards for products as well as the processes their safety and efficacy. Hence the need of the hour is to scientifically validate and conduct studies on quality, safety and efficacy of these traditional herbal formulations. With these objectives, in the present dissertation a traditional Siddha formulation Nilavembu Kudineer is selected based on the literature survey and scientifically evaluated for its anti-diabetic efficacy through both preclinical and clinical trial studies. Besides the selected Siddha herbal formulation is also studied from chemical and botanical standardization point of view in order to contribute to the suffering diabetic population a quality standard anti diabetic Siddha herbal drug. Following quality standards were determined for Nilavembu Kudineer Microscopic standards • Wavy epidermal cells. • Sclerenchyma cells with narrow lumen. • Vessels with simple pits and scalariform thickening, parenchyma cells with reticulation. • Tracheids are thick walled. • Fibres with branching and split ends, libriform, thin walled, with tapering end wide lumen. • Polygonal cork cells. • Presence of tricolpate pollen grains and group of fibres and brown content, slightly elongated and beaker shaped stone cells. • Presence of unicellular and short and long uniseriate trichomes with bi and tri cellular, short and long uniseriate multicellular headed glandular trichome. • Presence of stone cells and various shaped and striated sclereids. • Starch grains round to oval calcium oxalate crystals prismatic and acicular. Test for identity, purity and strength 1. pH not more than 7, 2. Loss on drying not more than 6%, 3. Total ash not more than 31% , 4. Acid insoluble ash not more than 2%, 5. Alcohol soluble extractives not less than 4%, 6. Water soluble extractives not less than 81%, MAJOR CHEMICAL CONSTITUENTS: Alkaloids, sterols, terpenoids, saponins, carbohydrates and mucilage 8.3 HPTLC profiles The HPTLC analysis of Nilavembu Kudineer revealed the presence of 11 spots with Rf at 0.31, 0.55, 0.58, 0.65, 0.70, 0.77, 0.82, 0.88, 0.92, 0.95 and 0.97 under 254 and 366 nm. The Rf value 0.70 indicates the presence of Andrographolide, the marker compound. 8.4 Acute oral toxicity studies Data of the results indicated that aqueous extract of Nilavembu Kudineer is non-toxic, and safe up to 2 g/kg, b. wt. through oral route. Anti-diabetic activity In the present study, STZ induced rats showed significant increase in the level of serum urea and creatinine, after treatment with Nilavembu Kudineer in diabetic rats for 28 days elevated serum urea and creatinine levels were found to be decreased significantly. The stabilization of these renal parameters by Nilavembu Kudineer suggests its protection against Diabetic nephropathy, which is one of the diabetic complications observed in chronic diabetic patients. If used as hypoglycemic agents, may also reverse dyslipedemia associated with diabetes and prevent the cardiovascular complications which are very prevalent in diabetic patients. CLINICAL STUDIES: • 6 subjects showed vatha naadi, 38 subjects showed pithta naadi and 4 subjects showed kapha and thontha naadi. • Based on body proportion 22 pitha subjects, 16 kapha subjects and 10 vatha subjects were identified. Among this, pitha and kapha people showed marked improvement whereas vatha people showed only symptomatic improvement. • Disorientation of pitha was found in 38 patients out of which 28 recovered. 2 of the 4 subjects with kapha disorientation, and 3 out of 6 subjects with vatha disorientation also recovered to normal. This indicates that this plant was more effective in treating pitha dominated diabetic complications as compared to vatha and kapha dominated complications. • Significant changes in fasting blood sugar were observed only in 28 patients. • 30 subjects showed significant improvement in post prandial glycemic level after treatment. • Glycated hemoglobin was markedly reduced in 20 patients. • Most of the subjects reported reduction in excessive appetite, which is the most common symptom of Type II Diabetes. RESULTS: The data of the results obtained clearly depict the anti-diabetic efficacy of Nilavembu Kudineer in human subjects. CONCLUSION: To conclude the study drug, Nilavembu Kudineer is proved for its quality, both botanically and chemically and is found to be safe, effective and economical in the management of type 2 Diabetes mellitus and its related complications such as nephropathy.

Item Type: Thesis (Masters)
Uncontrolled Keywords: siddha medicine ; management ; Madhumegam ; Type II Diabetes Mellitus; Clinical study.
Subjects: AYUSH > Maruthuvam
Depositing User: Subramani R
Date Deposited: 19 Aug 2017 10:04
Last Modified: 02 Jan 2019 01:17
URI: http://repository-tnmgrmu.ac.in/id/eprint/2707

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