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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus

• Registration Number: NCT02866539
• Lead Sponsor: Composite Interceptive Med Science

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Study Start: 2016-12
• Primary Completion: 2017-12-15
• Study Completion: 2018-01-15
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will contain an inert substance
Polyherbal capsule	Polyherbal capsule coccinia, bougainvillea, catharanthus	Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital; 🇮🇳 Bangalore, Karnataka, India