Health Condition 1: null- Diabetics aged between 35 to 65 years.
Conditions
Interventions
Intervention1: Mamajjaka Ghana Vati: Dose-2tablets(500mg each) bd
Dosage form- Tablet
Route and time of administration-Oral, 8am & 8pm
Vehicle-Lukewarm water
Duration of administration- 3 months
Contr
Sponsors
Central Council of Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glycosylated haemoglobin (HbA1c%)Timepoint: 0 day(Baseline) and 84th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in Blood sugar Fasting (10-12 hrs after dinner) and Post - Prandial. (100-120 minutes after breakfast) 2.Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ) 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. 3.At baseline and at the end of 12 weeks. | — |
Countries
India
Contacts
Public ContactDrShubhashree MN
Regional Ayurveda Research Institute for Metabolic disorders
Outcome results
None listed