Unhealthy diet and sedentary lifestyle as a cause in the development of Diabetes Mellitus and its treatment with some ayurvedic drugs

Phase 3

Completed

Brief Summary: A Randomised clinical trial has been designed to assess the efficacy of â€˜NyagrodhÄdi Vaá¹Ä«â€™ and â€˜Mehamudgara Vaá¹Ä«â€™ in the management of Madhumeha (Type-2 Diabetes Mellitus). Total 120 patients of Madhumeha (Type-2 Diabetes Mellitus) will be selected from Diabetic O.P.D. and O.P.D. of Roganidana Evam Vikrti Vijnana department of N.I.A. and randomly divided in 2 groups having 60 patients each. **Group A** (60 Patients) will be received NyagrodhÄdi Vaá¹Ä« , 6 gm /day in 3 divided doses (4 Vaá¹Ä« TDS, each Vaá¹Ä« of 500mg) for 6 weeks. **Group B** (60 Patients) will be received Mehamudgara Vaá¹Ä« , 1 gm /day in 2 divided doses (2 Vaá¹Ä« BD, each Vaá¹Ä« of 250mg) for 6 weeks. Patients will be reviewed on 15th, 30th and 45th day after their inclusion in trial. Assessment of effects of the therapy will be done on the basis of various subjective and objective criteria. Any change in sign and symptom will be noted. Laboratory investigation will be repeated after the completion of the trial and the result will be documented. Data will be analyzed using appropriate statistical tests.

Recruitment & Eligibility

Inclusion Criteria

Patients of type-2 diabetes fulfilling the criteria of American Diabetes Association (ADA) for Diabetes Mellitus.
Patients of age group 30 years â€“ 70 years of either gender.
Patients who shows clinical signs and symptoms of Madhumeha (type- 2 DM).

Exclusion Criteria

Patient of IDDM (type-1 D.M.) Complicated cases of Diabetes Mellitus.
Type-2 Diabetes patient on insulin therapy.
Patients with Gestational Diabetes Mellitus and lactating mother etc.
Patients with Fasting blood sugar more than 200 mg/dl and post prandial blood sugar more than 300 mg/dl.
Diabetic patients with severe complications like cardiovascular diseases, Nephropathy, Retinopathy, Diabetic foot etc.
Diabetes due to endocrinopathies e.g. Phaeochromocytoma, Acromegaly, Cushingâ€™s syndrome, Hyperthyroidism etc.
Patients with genetic syndromes associated with D.M. like Downâ€™s syndrome,Klinefelterâ€™s syndrome, Turnerâ€™s syndrome.

Primary Outcome Measures

Name	Time	Method
Developed low cost management in Madhumeha (Diabetes) for symptomatic relief in Madhumehi (Diabetic) patients.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Devoloped awareness about Santarpana Hetu(Unhealthy diet and Sedentary lifestyle) in Diabetic patients.	6 weeks

Locations (1): National Institute of Ayurveda, Jaipur
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
Dr Talekar Manisha Tatobaji
Principal investigator
8824854303
dr.mani21jan@gmail.com