Control of Blood Glucose Fluctuation With Usage of Polyherbal

Study Overview
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Brief Summary
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The aim of the study is to get insight into control of glycemic variability 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.

Detailed Description
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The glycemic variability would be obtained at 14 days with the usage of Flash glucose monitoring system manufactured by Abbott and outcomes would be compared at the end of ambulatory glucose profile.

Official Title
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Control of Glycemic Variability Using a Polyherbal: A Randomized Placebo Controlled Study of Whole Herb Formulations

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 ≥18 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria Fasting Plasma Glucose ≥100 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND Glycosylated haemoglobin (A1C) ≥ 6 %. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized within last 3 months. Exclusion Criteria: Any one of the following Patients on Insulin therapy. Any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes. Women in child bearing age unable to practice any form of contraception Patients with diagnosis of Anemia (Hb<11 g/dl in Female and <13 g/dl in Male) Impaired renal function; estimated estimated glomerular filtration rate <60mls/min/1.73m2. Known history of any chronic illness taking regular pharmacological agents. Blood pressure fluctuations exceeding 20 mm of Hg on 2 subsequent clinic visits or known history of hypo tension or bradycardia in last 6 months or taking 3 or more anti-hypertensive medications regularly in the last 6 weeks Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy Current or former employees of organic India or any potential conflict of interest in participation 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: 18 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<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 |
| --- | --- | --- |
| Mean amplitude glycemic excursion | To demonstrate that the difference in mean amplitude glycemic excursions among patients receiving polyherbal medication will be less than 1mmol/dL or 18mg/dL for a sampling frequency: 1 every 15 minutes over 14 days | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean estimated glycated hemoglobin | Mean estimated glycated hemoglobin difference between test and placebo control group | 14 days | 
| Number of hypoglycemia episodes | Number of hypoglycemia episodes and duration of hypoglycemia in treatment group | 14 days |