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

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)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

  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 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
  3. 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
  4. 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

  1. History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin)
  2. Any history suggestive of micro vascular or macro vascular disease
  3. Women in childbearing age unable to practice any form of contraception
  4. Impaired renal function; estimated glomerular filtration rate(eGFR) <60mls/min/1.73m2.
  5. Known history of any chronic illness taking regular pharmacological agents.
  6. 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
  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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Composite Interceptive Med Science
• Investigators: Principal Investigator: Alben Sigamani, MD, Narayana Hrudayalaya Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Glucose Intolerance
• Other Study ID Numbers: OI - 001 - 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No