Effect of Polyherbal Compound for Control of Blood Sugar in Impaired Glucose Tolerance and Diabetes

Study Overview
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Brief Summary
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The aim of the study is to control blood sugar with Sugar Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.

Official Title
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A Polyherbal for Control of Blood Sugar in Subjects With Impaired Glucose Tolerance and/or Early Type 2 Diabetes. A Randomized Placebo Controlled Study of a Polyherbal (Whole Herb Formulation)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult males and non-pregnant females aged ≥30 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) and a diabetes and a meeting one of the following criteria Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR 2-h Post load Glucose ≥140 mg/dL during an Oral Glucose Tolerance Test (OGTT). The test should be performed as described by the World Health Organisation(WHO), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. OR Glycosylated haemoglobin (A1C) ≥5.7%. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized. OR In a patient with classic symptoms of hyperglycaemia or hyperglycaemic crisis, a random plasma glucose ≥200 mg/dL in the last 12 months. Exclusion Criteria: Any one of the following History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin) Any history suggestive of micro vascular or macro vascular disease Women in childbearing age unable to practice any form of contraception Impaired renal function; estimated glomerular filtration rate(eGFR) <60mls/min/1.73m2. Known history of any chronic illness taking regular pharmacological agents. Blood pressure fluctuations exceeding 10 mmHg 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 Current or former employees of organic India Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polyherbal capsule<br>Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea. | Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus<br>* A unique combination of 3 herbs that lower blood sugars<br>* Other names: Sugar Balance (SB);|
| Placebo Comparator: Placebo<br>Placebo will contain an inert substance | Drug: Placebo<br>* Similar looking inactive powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of diabetes subjects achieving glycemic control | a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose <180 mg/dl | 6 months | 
| Number of pre-diabetes achieving euglycemic status | measured as A1c < 5.7% and/or fasting plasma glucose <100mg/dl/ | 6 months |