Evaluation of Gamma-oryzanol in Type-2 diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2020/06/026007
- Lead Sponsor
- AP Organics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
i. Type-2 DM <5 years duration
ii. On stable oral hypoglycaemic agents
Metformin ± Sulfonylurea)
iii. No change in anti-diabetic
treatment for the last 3 months.
iv. HbA1c <7.5%
v. Fasting plasma glucose not exceeding 180mg/dL
vi. Patients with Negative Urine sugar
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in fasting and Post Prandial blood glucose levelsTimepoint: Baseline (0-week), 4, 8 and 12 weeks
- Secondary Outcome Measures
Name Time Method Change in insulin resistance (HOMA-IR) in the gamma-oryzanol and placebo groups at 12 weeks. <br/ ><br>Timepoint: 0 and 12 weeks;Change in islet beta cell function (HOMA-β) in the gamma-oryzanol and placebo groups at 12 weeks. <br/ ><br>Timepoint: 0 and 12 weeks;Change in Serum Insulin level and HbA1C level from baseline to 12 weeks in both groups. <br/ ><br> <br/ ><br>Timepoint: 0 and 12 weeks;To assess the adverse drug reactions in both groups.Timepoint: 0 and 12 weeks