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

Diabetes Mellitus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866539
• Other study ID #: OI - 001 - 2016
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: April 10, 2018
• Start date: December 2016
• Est. completion date: January 15, 2018

Study information

• Verified date: April 2018
• Source: Organic India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 15, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance

Intervention

Drug:
• Polyherbal capsule coccinia, bougainvillea, catharanthus
A unique combination of 3 herbs that lower blood sugars
• Placebo
Similar looking inactive powder

Locations

Country	Name	City	State
India	Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Organic India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of pre-diabetes achieving euglycemic status	measured as A1c < 5.7% and/or fasting plasma glucose <100mg/dl/	6 months