Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: AYUSH D: Metformin tablets upto 1.5 g per day and 2 tablets of AYUSH D, 1 gm each g x 3 times /day
Control Intervention1: placebo: Metformin tablets upto 1.5 g per day and 2 tablets o
Sponsors
Incharge
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged between 18 to 70 years. 2. Diagnosed patient of Type 2 Diabetes having Glycosylated Haemoglobin (HbA1c) between 7% - 9% 3. Willing to participate and able to provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Subject of type 1 DM or type 2 DM on insulin/OHAâ??s other than metformin/any other AYUSH medication for glucose control. 2. Subjects suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, nephropathy, retinopathy, etc. which require an urgent treatment. 3. Subjects with uncontrolled hypertension (with or without medication >140/90mmHg after 5 mins of rest) 4. Subjects with established diagnosis of CAD requiring any procedure in next 6 months â?? angioplasty on bypass surgery or subjects with New York Heart Association (NYHA) Classification Category III and IV cardiac insufficiency, or any other clinically significant cardiovascular disease. 5. Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > greater than ULL),uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects) 6. Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy. 7. Pregnant / Lactating women. 8. Subject on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy. 9. Subjects who have a recent history or who are currently known to abuse alcohol or drugs. 10. Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years). 11. Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 12. Subjects who have completed participation in any other clinical trial during the past three months. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glycosylated hemoglobin (HbA1c %) at base line, 12 weeks and end of 24 weeks.Timepoint: Change in Glycosylated hemoglobin (HbA1c %) at base line, 12 weeks and end of 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FBS, PPBS, plasma Insulin, HOMA-IR, lipid profile, waist circumference and BMI, in SF-36 (RAND) Health Survey Score, Diabetes Symptoms Questionnaire (DSQ), SAE /ADR :at base line, at the end of 12 week, 24 weeksTimepoint: at base line, at the end of 12 week, 24 weeks | — |
Countries
India
Contacts
Public ContactDr Kishore Kumar R
Regional Ayurveda Research Institute for Metabolic Disorders (CCRAS, New Delhi)
Outcome results
None listed