Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Ministry of AYUSH Govt of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex, 18-70 years 2. Freshly diagnosed or known diabetic subjects with HbA1c of 7-9% (both values included). 3. Subjects who are drug naive or on any OHA 4. Subjects who agree to participate in the study and submit a written informed consent form
Exclusion criteria
Exclusion criteria: 1. Subject diagnosed with type 1 Diabetes Mellitus. 2. Subjects who are on Insulin therapy 3. Subjects with Haemoglobin percentage 4. Subjects with uncontrolled hypertension (with or without medication systolic >150 and/or diastolic >100 mmHg after 10 minutes of rest) 5. Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease. 6. Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) 7. Renal Dysfunction (defined as Egfr 8. Uncontrolled acute Pulmonary Dysfunction requiring inhalation or systemic steroids. 9. 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. 10. Pregnant / Lactating women. 11. Subject on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy. 12. Subjects with current diagnosis of malignancy or in last five years. 13. Subjects suffering from major systemic illness necessitating long term drug treatment (defined as more than 3 months). 14. Subjects who have completed participation in any other clinical trial during the past three months. 15. Any other condition which the Investigator thinks may jeopardize the safety of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Glycosylated Hemoglobin (HbA1c)Timepoint: Baseline and at 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Fasting blood sugar (min 8 hrs after dinner)Timepoint: Baseline, 4th, 8th, 12th week;2. Change in Post prandial blood sugar (2 hours after breakfast)Timepoint: Baseline, 4th, 8th, 12th week;3.Change in Lipid profileTimepoint: Baseline and 12th week;4.Change in BMI and Waist circumferenceTimepoint: Baseline 4th,8th,12th week;5. Change in Symptoms - Diabetes Symptoms Questionnaire (DSQ)Timepoint: Baseline, 4th, 8th, 12th week;6. Change in Symptoms - Ayurveda Symptoms Questionnaire (ASQ)Timepoint: Baseline and at 12th week;7. Any SAE /ADR or change in laboratory parametersTimepoint: 4th, 8th, 12th week | — |
Countries
India
Contacts
Public ContactDr Kavya N
Central Ayurveda Research Institute, Bengaluru
Outcome results
None listed