Effect of Polyherbal Compound for Control of Blood Sugar... | NCT02866539

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

NCT02866539

Sponsor

Composite Interceptive Med Science

Status

Completed

Last Update Posted

Apr 11, 2018Actual

Enrollment

122Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus

Interventions

Polyherbal capsule coccinia, bougainvillea, catharanthus
Placebo

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 15, 2017Actual

Completion Date

Jan 15, 2018Actual

First Submitted Date

Aug 4, 2016

First Submission Date that Met QC Criteria

Aug 10, 2016

First Posted Date

Aug 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2018

Last Update Posted Date

Apr 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Polyherbal capsule	Active Comparator	Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea.	Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus
Placebo	Placebo Comparator	Placebo will contain an inert substance	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polyherbal capsule coccinia, bougainvillea, catharanthus	Drug	A unique combination of 3 herbs that lower blood sugars	Polyherbal capsule

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases