Control of Blood Glucose Fluctuation With Usage of Polyherbal

NCT ID: NCT03143803

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-05
• Study Completion Date: 2017-08-30

Brief Summary

The aim of the study is to get insight into control of glycemic variability 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

The glycemic variability would be obtained at 14 days with the usage of Flash glucose monitoring system manufactured by Abbott and outcomes would be compared at the end of ambulatory glucose profile.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Polyherbal

Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea.

Group Type: ACTIVE_COMPARATOR

Polyherbal capsule coccinia, bougainvillea, catharanthus

Intervention Type: DRUG

A unique combination of 3 herbs that lower blood sugars

Placebo

Placebo will contain an inert substance

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Similar looking inactive powder

Interventions

Polyherbal capsule coccinia, bougainvillea, catharanthus

A unique combination of 3 herbs that lower blood sugars

Intervention Type: DRUG

Placebo

Similar looking inactive powder

Intervention Type: DRUG

Other Intervention Names

Sugar Balance (SB)

Eligibility Criteria

Inclusion Criteria

Adult males and non-pregnant females aged ≥18 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria

1. Fasting Plasma Glucose ≥100 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND

2. Glycosylated haemoglobin (A1C) ≥ 6 %. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized within last 3 months.

Exclusion Criteria

Any one of the following

1. Patients on Insulin therapy.

2. Any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes.

3. Women in child bearing age unable to practice any form of contraception

4. Patients with diagnosis of Anemia (Hb<11 g/dl in Female and <13 g/dl in Male)

5. Impaired renal function; estimated estimated glomerular filtration rate <60mls/min/1.73m2.

6. Known history of any chronic illness taking regular pharmacological agents.

7. Blood pressure fluctuations exceeding 20 mm of Hg on 2 subsequent clinic visits or known history of hypo tension or bradycardia in last 6 months or taking 3 or more anti-hypertensive medications regularly in the last 6 weeks

8. Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy

9. Current or former employees of organic India or any potential conflict of interest in participation

10. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.

11. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Composite Interceptive Med Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alben Sigamani

Role: PRINCIPAL_INVESTIGATOR

Narayana Hrudayalaya Hospital

Locations

Mazumdar Shaw Medical Centre

Bangalore, Karnataka, India

Countries

India

Other Identifiers

OI-005-2017

Identifier Type: -

Identifier Source: org_study_id