Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Valyou products private limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female patients aged 30-65 years 2. Diabetic patients on OHA. 3. Patients whose HbA1C is > 8.0% and 120 mg/dL to 170 mg/dL and 2-hr PP >= 200 mg/dL. 4. Able to do moderate intensity physical exercise and life style modification 5. Patients ready to give written informed consent and willing to comply the study protocol
Exclusion criteria
Exclusion criteria: 1. Antiplatelet, ACE Inhibitors, ARBs, Lipid lowering drug. 2. NASIDS (prolonged use for more than 10 days). 3. Any herbal supplement/ drug. 4. Blood pressure: BP >160/100 mmHg. 5. Any clinical history of cardiovascular disease, Liver, hormonal disorder or treatment or kidney disease. 6. History of peptic ulcer disease and/or GI. bleeding/perforation 7. History of cancer. 8. History or presence of proliferative retinopathy, severe non￾proliferative retinopathy, macular edema or presence of untreated diabetic eye disease. 9. History of treated peripheral or autonomic neuropathy. 10. Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential. 11. Presence of any severe medical or psychological condition or chronic condition/inflammation/infection that in the opinion of the investigator would compromise the patientâ??s safety or successful participation in the study. 12. Participation in any other clinical study within 30 days of screening. 13. Systemic long-acting corticosteroids (prolonged use for more than 10 days) or immunosuppressants. 14. History of allergy to any of the drugs / investigational products. 15. History of chronic alcoholism. 16. Planned surgical intervention during the expected study duration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels at the end of 12 weeks and 24 weeks in the groups from screening.Timepoint: Screening Week 12 Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FBS levels Change in PPBS levels Change in Lipid profile levelsTimepoint: Screening Week 12 Week 24 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Valyou Products Private Limited
Outcome results
None listed