Effect of poly herbal compound for control of blood sugar in impaired glucose tolerance and early type 2 diabetes
- Conditions
- Health Condition 1: null- Type 2 Diabetes
- Registration Number
- CTRI/2016/11/007435
- Lead Sponsor
- Organic India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 122
Adult males and non-pregnant females aged >=30 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria
1.Fasting Plasma Glucose >=100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
2.2-h Post load Glucose >=140 mg/dL during an OGTT. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. OR
3.Glycosylated haemoglobin (A1C) >=5.7%. The test should be performed in a laboratory using a method that is NABL certified and standardized. OR
4.In a patient with classic symptoms of hyperglycaemia or hyperglycaemic crisis, a random plasma glucose >=200 mg/dL in the last 12 months.
Any one of the following
1.History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin) or Insulin.
2.Any history suggestive of micro vascular or macro vascular disease
3.Women in child bearing age unable to practice any form of contraception
4.Impaired renal function; eGFR <60mls/min/1.73m2.
5.Known history of any chronic illness taking regular pharmacological agents.
6.Blood pressure fluctuations exceeding 10mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 2 or more antihypertensive medications regularly in the last 6 weeks
7.Current or former employees of organic India
8.Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
9.Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective at 6 months is as follows <br/ ><br>1.In patients with diabetes; a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose 180 mg/dl <br/ ><br>2.In those with pre-diabetes it will be achieving eugylcemic status measured as A1c 5.7% and/or fasting plasma glucose 100 mg/dl/ <br/ ><br>Timepoint: The primary objective at 6 months is as follows <br/ ><br>1.In patients with diabetes; a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose 180 mg/dl <br/ ><br>2.In those with pre-diabetes it will be achieving eugylcemic status measured as A1c 5.7% and/or fasting plasma glucose 100 mg/dl/ <br/ ><br>
- Secondary Outcome Measures
Name Time Method umber of diabetes patients with hypoglycemia as adverse eventsTimepoint: 1 months