Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Central Council of Research in Ayurvedic Sciences (CCRAS) Ministry of Ayush, Govt. of India)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex and age between 18 to 65 years. 2. Subjects of BMI more than 18.5 to 34.9 kg/m2 (Normal, Overweight & Obesity class- 1). 3. Diagnosed subjects of DM type 2 on Oral Hypoglycemic Agents. 4. Subjects having Glycated haemoglobin (HbA1c) 8 to 10 percent. 5. Willing to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. DM Type 2 subjects using insulin with OHA. 2. Participants diagnosed with DM Type 2 who have a baseline HbA1c more than 10 percent or who, in the opinion of the investigator, require initiation of insulin therapy for glycemic control. 3. Patients with poorly controlled Hypertension (BP more than 160/100 mm Hg). 4. Major surgery in the last 3 months. 5. Haematological disease that interferes with HbA1c determination. 6. Presence of any chronic or such other diseased condition, current or anticipated, that limits participation in the study or has the potential to affect the outcomes. 7. Patients who are on corticosteroids, anti-psychotics, anti-depressants, anti-cholinergic, anti-epileptics, immune-suppressants, Hormonal replacement therapy or any other drugs that may influence outcome of the study. 8. Participation in another clinical trial in last 06 months will be excluded. 9. Patients with a H/O significant systemic illness which might interfere with the compliance of the trial drug (Rheumatoid arthritis, Tuberculosis, Inflammatory Bowel Disease, etc.). 10. Patients who have a history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke, or other cardiac illnesses that warrant treatment. 11. Known cases of HIV and AIDS & Patients suffering from malignancy. 12. Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and,or Alanine Amino Transferase (ALT) more than 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine more than 1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and,or Chronic Obstructive Pulmonary Disease (COPD). 13. Women who are planning for conception, pregnant or lactating. 14. History of hypersensitivity to any of the trial drugs or their ingredients. 15. Any other condition that the Investigator thinks may jeopardize the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Changes in fasting C-peptide and fasting Insulin levelsTimepoint: Baseline, 03 months and 06 months;Proportion of participants achieving optimal glycemic control (optimal control defined as HbA1c less or equal to 7 percent)Timepoint: Baseline, 03 months and 06 months;Changes in Fasting Blood Glucose (FBG) & Post-Prandial Blood Glucose (PPBG)Timepoint: Baseline, 01 month, 02 months, 03 months, 04 months, 05 months and 06 months;Changes in Anthropometric parameters like weight, BMI and waist circumferenceTimepoint: Baseline, 01 month, 02 months, 03 months, 04 months, 05 months and 06 months;Changes in Lipid Profile, LFT and KFT parametersTimepoint: Baseline, 03 months and 06 months;Incidence of any AE/ADRTimepoint: Baseline, 01 month, 02 months, 03 months, 04 months, 05 months and 06 months;Changes in Quality-of-Life parameters through WHO-QOL Bref and Diabetes Distress - Screening Scale (DDS17)Timepoint: Baseline, 01 month, 02 months, 03 months, 04 months, 05 months and 06 months | — |
Primary
| Measure | Time frame |
|---|---|
| Change in mean HbA1c Timepoint: Baseline, 03 months and 06 months | — |
Countries
India
Contacts
Public ContactDr Jeuti Rani Das
Central Ayurveda Research Institute, CCRAS, Guwahati
Outcome results
None listed