Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Ayurswasthya Yojana, Ministry of Ayush, Govt of India
Eligibility
Inclusion criteria
Inclusion criteria: I. Subjects of either sex, 18-60 years. II. Known diabetic subjects with fasting blood glucose between 150mg/dL-200mg/dL(both values included) and/or post prandial blood glucose between 180mg/dL -300mg/dL (both values included) III. Subjects who are on stable dose of any OHA (Oral hypoglycemic agent). IV. Subjects who agree to participate in the study and submit a written informed consent form.
Exclusion criteria
Exclusion criteria: I. Subject diagnosed with type 1 Diabetes Mellitus. II. Subjects who are on Insulin therapy. III. Patients with confirmed diagnosis of diabetic complications like diabetic retinopathy, neuropathy, nephropathy, non-healing wounds, gangrene/ amputed limbs/toes. IV. Subjects with Haemoglobin percentage less than 8 g/dl. V. Subjects with uncontrolled hypertension (with or without medication systolic more than 150 and/or diastolic more than 100 mmHg after 10 minutes of rest) VI. Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease. VII. Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT more than 3 times of the upper normal limit) VIII. Subjects with Renal Dysfunction (defined as eGFR less than 60 ml/min. ) IX. Subjects with Uncontrolled acute Pulmonary Dysfunction requiring inhalation or systemic steroids. X. Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy. XI. Pregnant / Lactating women. XII. Subjects on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy. XIII. Subjects with current diagnosis of malignancy or in last five years. XIV. Subjects who have completed participation in any other interventional clinical trial during the past three months. XV. Any other condition which the Investigator thinks may jeopardize the safety of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Fasting blood glucose (minimum 8 hrs after dinner), Post prandial blood sugar (2 hours after breakfast), Plasma Insulin and HOMA-IRTimepoint: Baseline and 42nd day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in BMI and waist circumferenceTimepoint: Baseline and 42nd day;2. Change in Lipid profileTimepoint: Baseline and 42nd day;3. Change in renal function, liver function, hematology, urine analysisTimepoint: Baseline and 42nd day;4. Any SAE /ADR or change in laboratory parametersTimepoint: Baseline and 42nd day;5. Change in Symptoms ââ?¬â?? Diabetes Symptom questionnaire (DSQ)Timepoint: Baseline and 42nd day;6. Change in Symptoms - Simplified nutritional appetite questionnaire (SNAQTimepoint: Baseline and 42nd day;7. Change in Agni - Agni assessment tool developed by CCRASTimepoint: Baseline and 42nd day;8. Acceptability of the ready-to-cook dietary supplementTimepoint: 21st day | — |
Countries
India
Contacts
Public ContactDr Vrinda
Central Ayurveda Research Institute
Outcome results
None listed