Control of Blood Glucose Fluctuation With Usage of Polyherbal

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus; Drug: Placebo

• Registration Number: NCT03143803
• Lead Sponsor: Composite Interceptive Med Science

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.

Study Timeline

• Study First Submitted: 2017-05-02
• Study Start: 2017-05-05
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-08
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyherbal	Polyherbal capsule coccinia, bougainvillea, catharanthus	Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea.
Placebo	Placebo	Placebo will contain an inert substance

Primary Outcome Measures

Name	Time	Method
Mean amplitude glycemic excursion	14 days	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

Secondary Outcome Measures

Name	Time	Method
Mean estimated glycated hemoglobin	14 days	Mean estimated glycated hemoglobin difference between test and placebo control group
Number of hypoglycemia episodes	14 days	Number of hypoglycemia episodes and duration of hypoglycemia in treatment group

Trial Locations

Locations (1)

Mazumdar Shaw Medical Centre; 🇮🇳 Bangalore, Karnataka, India