Clinical trial NCT02866539: Effect of Polyherbal Compound for Control of Blood Sugar in Impaired Glucose Tolerance and Diabetes
Official title: A Polyherbal for Control of Blood Sugar in Subjects With Impaired Glucose Tolerance and/or Early Type 2 Diabetes. A Randomized Placebo Controlled Study of a Polyherbal (Whole Herb Formulation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
First posted: 2016-08-15
Enrollment: 122
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of diabetes subjects achieving glycemic control
timeFrame: 6 months
measure: Number of pre-diabetes achieving euglycemic status
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital
state: Karnataka
Study officials:
affiliation: Narayana Hrudayalaya Hospital
name: Alben Sigamani, MD
role: PRINCIPAL_INVESTIGATOR
References: