Control of Blood Glucose Fluctuation With Usage of Polyherbal

Composite Interceptive Med Science

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus

Study type: Interventional

Funder types: Industry

Identifiers

NCT03143803

OI-005-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Polyherbal

Active Comparator group

Description:

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

Treatment:

Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus

Placebo

Placebo Comparator group

Description:

Placebo will contain an inert substance

Treatment:

Drug: Placebo