Health Condition 1: null- Type 2 Diabetes mellitus
Conditions
Interventions
Intervention1: GycaCare II: To be administered orally b.i.d. Tablets to be administered morning and night 20 minutes before food for a period of 120 days + 3 days
Control Intervention1: Glycirite: To
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 30 and 65 years. 2. Ability to comply to the study protocol 3. Willing to give the written informed consent Arm A: 4. Pre diabetic patients without allopathic medications treatment. 5. HbA1c of (5.6% - 6.4% (both inclusive)). Arm B: 6. Newly diagnosed type II diabetic patients with allopathic medications treatment. 7. HbA1c of (6.5% - 7.5% (both inclusive)).
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactating 2. History of acute or chronic illness (such as cancer or arthritis rheumatoid). 3. Patients with type 1 diabetes, hypo and hyper thyroidism and hyperlipidemia. 4. Patients with the history of serious Hepatic Dysfunction or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients). 5. Patient with poorly controlled Hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Change in HbA1C values 2 Change in fasting and postprandial blood glucoseTimepoint: 1 HbA1C values-Screening and Day 120 2 Fasting and postprandial blood glucose-Screening,Day0,20,40,60,80,100 and 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Changes in biochemical parameters-Total serum Cholesterol, Triglyceride, LDL-Cholesterol, HDL-Cholesterol, VLDL, Aspartate transaminase, Alanine transaminase, Serum Creatinine, Uric acid 2 Assessment of adverse eventsTimepoint: 1 Biochemical Parameters-Screening and Day 120 2 Adverse events-Day20,40,60,80,100,120 and follow up | — |
Countries
India
Contacts
Public ContactMr Subramanian Jagadeesan
ClinWorld(P)Limited
Outcome results
None listed