Clinical trial on Madhumeha (Type-2 Diabetes mellitus) with Mamajjaka ghanavati
- Conditions
- Health Condition 1: null- Diabetics aged between 35 to 65 years.
- Registration Number
- CTRI/2017/09/009887
- Lead Sponsor
- Central Council of Research in Ayurvedic Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
1.Diabetics aged between 35 to 65 years.
2.Patients who are diagnosed to be Type II Diabetics by having Glycosylated Haemoglobin (HbA1c) between 6.5% - 9% or BS-F between 126 mg% - 200 mg% or BS-PP / Random between 200 mg% - 250 mg%.
3. Willing to participate and able to provide signed informed consent.
1. Patients suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.
2. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
3.Hypertensive patients ( > 140 / 90 mm Hg).
Symptomatic patient with clinical evidence of Heart failure.
4.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
5. Pregnant / Lactating women.
6. Patient on steroids, oral contraceptive pills or estrogens replacement therapy.
7. Alcoholics and/or drug abusers.
8.Patients with evidence of malignancy
9.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
10.H/o hypersensitivity to any of the trial drugs or their ingredients.
11.Patients who have completed participation in any other clinical trial during the past six (06) months.
12.Any other condition which the Investigator thinks may jeopardize the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Glycosylated haemoglobin (HbA1c%)Timepoint: 0 day(Baseline) and 84th day
- Secondary Outcome Measures
Name Time Method 1.Change in Blood sugar Fasting (10-12 hrs after dinner) and Post - Prandial. (100-120 minutes after breakfast) <br/ ><br>2.Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ) <br/ ><br>3.Changes in the quality of life of the patients by using SF-36 (RAND) Health related QoL Survey questionnaireTimepoint: 1. and 2. - At base line, at the end of 4 weeks, 8 weeks & 12 weeks. <br/ ><br>3.At baseline and at the end of 12 weeks.