Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02866539
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus Drug: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : December 2016
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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 Name: Sugar Balance (SB)

Placebo Comparator: Placebo
Placebo will contain an inert substance
Drug: Placebo
Similar looking inactive powder




Primary Outcome Measures :
  1. Number of diabetes subjects achieving glycemic control [ Time Frame: 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

  2. Number of pre-diabetes achieving euglycemic status [ Time Frame: 6 months ]
    measured as A1c < 5.7% and/or fasting plasma glucose <100mg/dl/



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866539


Locations
Layout table for location information
India
Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital
Bangalore, Karnataka, India, 560099
Sponsors and Collaborators
Composite Interceptive Med Science
Investigators
Layout table for investigator information
Principal Investigator: Alben Sigamani, MD Narayana Hrudayalaya Hospital

Layout table for additonal information
Responsible Party: Composite Interceptive Med Science
ClinicalTrials.gov Identifier: NCT02866539     History of Changes
Other Study ID Numbers: OI - 001 - 2016
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia