Control of Blood Glucose Fluctuation With Usage of Polyherbal

Control of Glycemic Variability Using a Polyherbal: A Randomized Placebo Controlled Study of Whole Herb Formulations

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Mazumdar Shaw Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo will contain an inert substance	Drug: Placebo; Similar looking inactive powder
Active Comparator: Polyherbal; 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 Names: Sugar Balance (SB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean amplitude glycemic excursion	To demonstrate that the difference in mean amplitude glycemic excursions among patients receiving polyherbal medication will be less than 1mmol/dL or 18mg/dL for a sampling frequency: 1 every 15 minutes over 14 days	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean estimated glycated hemoglobin	Mean estimated glycated hemoglobin difference between test and placebo control group	14 days
Number of hypoglycemia episodes	Number of hypoglycemia episodes and duration of hypoglycemia in treatment group	14 days

Collaborators and Investigators

• Sponsor: Composite Interceptive Med Science
• Investigators: Principal Investigator: Alben Sigamani, Narayana Hrudayalaya Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): August 14, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: OI-005-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No