Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Gamma Oryzanol Capsule: Capsule Gamma-Oryzanol (150 mg) twice daily orally along with Standard treatment for type-2 diabetes
Control Intervention1: Matched Placebo: Matched Placebo twic
Sponsors
AP Organics
Eligibility
Inclusion criteria
Inclusion criteria: i. Type-2 DM ii. On stable oral hypoglycaemic agents Metformin ± Sulfonylurea) iii. No change in anti-diabetic treatment for the last 3 months. iv. HbA1c v. Fasting plasma glucose not exceeding 180mg/dL vi. Patients with Negative Urine sugar
Exclusion criteria
Exclusion criteria: i. Diabetes other than type 2 diabetes mellitus ii. Evidence of renal disease (S. Creatinine > 1.5mg/ml) iii. Evidence of liver disease (AST/ALT >3 times of normal) iv. Pregnant and lactating mothers and women intending pregnancy v. Participation in any other clinical trial with in the last 30 days vi. History of any hemoglobinopathy that may affect determination of Glycosylated Haemoglobin vii. Treatment with oral anti-diabetic agents (other than Metformin or SU) during the 12 weeks before baseline visit. viii. History of intolerance or hypersensitivity to sulfonylurea or Metformin or Gamma-oryzanol. ix. Any condition which in the opinion of the PI that is significant and can make the patient unsuitable for study or can place it under additional risk, such as intolerance, allergy to Gamma-oryzanol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in fasting and Post Prandial blood glucose levelsTimepoint: Baseline (0-week), 4, 8 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in insulin resistance (HOMA-IR) in the gamma-oryzanol and placebo groups at 12 weeks. Timepoint: 0 and 12 weeks;Change in islet beta cell function (HOMA-β) in the gamma-oryzanol and placebo groups at 12 weeks. Timepoint: 0 and 12 weeks;Change in Serum Insulin level and HbA1C level from baseline to 12 weeks in both groups. Timepoint: 0 and 12 weeks;To assess the adverse drug reactions in both groups.Timepoint: 0 and 12 weeks | — |
Countries
India
Contacts
Public ContactDebasish Hota
AIIMS Bhubabeswar
Outcome results
None listed