Effect of Polyherbal Compound for Control of Blood Sugar in Impaired Glucose Tolerance and Diabetes

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

NCT02866539

OI - 001 - 2016

Details and patient eligibility

About

The aim of the study is to control blood sugar 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.

Enrollment

122 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult males and non-pregnant females aged ≥30 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) and a diabetes and a meeting one of the following criteria
1. Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
2. 2-h Post load Glucose ≥140 mg/dL during an Oral Glucose Tolerance Test (OGTT). The test should be performed as described by the World Health Organisation(WHO), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. OR
3. Glycosylated haemoglobin (A1C) ≥5.7%. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized. OR
4. In a patient with classic symptoms of hyperglycaemia or hyperglycaemic crisis, a random plasma glucose ≥200 mg/dL in the last 12 months.

Exclusion criteria

Any one of the following
1. History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin)
2. Any history suggestive of micro vascular or macro vascular disease
3. Women in childbearing age unable to practice any form of contraception
4. Impaired renal function; estimated glomerular filtration rate(eGFR) <60mls/min/1.73m2.
5. Known history of any chronic illness taking regular pharmacological agents.
6. Blood pressure fluctuations exceeding 10 mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 2 or more antihypertensive medications regularly in the last 6 weeks
7. Current or former employees of organic India
8. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
9. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.