Back to resultsEffect of Polyherbal Compound for Control of Blood Sugar in Impaired Glucose Tolerance and Diabetes
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Polyherbal capsule coccinia, bougainvillea, catharanthus
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility 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
- Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
- 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
- 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
- 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
- History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin)
- Any history suggestive of micro vascular or macro vascular disease
- Women in childbearing age unable to practice any form of contraception
- Impaired renal function; estimated glomerular filtration rate(eGFR) <60mls/min/1.73m2.
- Known history of any chronic illness taking regular pharmacological agents.
- 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
- Current or former employees of organic India
- 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.
Sites / Locations
- Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Polyherbal capsule
Placebo
Arm Description
Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea.
Placebo will contain an inert substance
Outcomes
Primary Outcome Measures
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
Number of pre-diabetes achieving euglycemic status
measured as A1c < 5.7% and/or fasting plasma glucose <100mg/dl/
Secondary Outcome Measures
Full Information
NCT ID
NCT02866539
First Posted
August 4, 2016
Last Updated
April 10, 2018
Sponsor
Composite Interceptive Med Science
1. Study Identification
Unique Protocol Identification Number
NCT02866539
Brief Title
Effect of Polyherbal Compound for Control of Blood Sugar in Impaired Glucose Tolerance and Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
January 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Composite Interceptive Med Science
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyherbal capsule
Arm Type
Active Comparator
Arm Description
Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will contain an inert substance
Intervention Type
Drug
Intervention Name(s)
Polyherbal capsule coccinia, bougainvillea, catharanthus
Other Intervention Name(s)
Sugar Balance (SB)
Intervention Description
A unique combination of 3 herbs that lower blood sugars
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Similar looking inactive powder
Primary Outcome Measure Information:
Title
Number of diabetes subjects achieving glycemic control
Description
a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose <180 mg/dl
Time Frame
6 months
Title
Number of pre-diabetes achieving euglycemic status
Description
measured as A1c < 5.7% and/or fasting plasma glucose <100mg/dl/
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
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
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
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
History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin)
Any history suggestive of micro vascular or macro vascular disease
Women in childbearing age unable to practice any form of contraception
Impaired renal function; estimated glomerular filtration rate(eGFR) <60mls/min/1.73m2.
Known history of any chronic illness taking regular pharmacological agents.
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
Current or former employees of organic India
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alben Sigamani, MD
Organizational Affiliation
Narayana Hrudayalaya Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Polyherbal Compound for Control of Blood Sugar in Impaired Glucose Tolerance and Diabetes
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