Control of Blood Glucose Fluctuation With Usage of Polyherbal

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143803
• Other study ID #: OI-005-2017
• Status: Completed
• Phase: N/A
• First received: May 2, 2017
• Last updated: September 1, 2017
• Start date: May 5, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: September 2017
• Source: Organic India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 30, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Polyherbal capsule coccinia, bougainvillea, catharanthus
A unique combination of 3 herbs that lower blood sugars
• Placebo
Similar looking inactive powder

Locations

Country	Name	City	State
India	Mazumdar Shaw Medical Centre	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Organic India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean estimated glycated hemoglobin	Mean estimated glycated hemoglobin difference between test and placebo control group	14 days
Secondary	Number of hypoglycemia episodes	Number of hypoglycemia episodes and duration of hypoglycemia in treatment group	14 days