NCT02866539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

August 4, 2016

Last Update Submit

April 10, 2018

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Number of diabetes subjects achieving glycemic control

    a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose \<180 mg/dl

    6 months

  • Number of pre-diabetes achieving euglycemic status

    measured as A1c \< 5.7% and/or fasting plasma glucose \<100mg/dl/

    6 months

Study Arms (2)

Polyherbal capsule

ACTIVE COMPARATOR

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

Drug: Polyherbal capsule coccinia, bougainvillea, catharanthus

Placebo

PLACEBO COMPARATOR

Placebo will contain an inert substance

Drug: Placebo

Interventions

Polyherbal capsule coccinia, bougainvillea, catharanthusDRUG

A unique combination of 3 herbs that lower blood sugars

Also known as: Sugar Balance (SB)
Polyherbal capsule
PlaceboDRUG

Similar looking inactive powder

Placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
  • 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
  • 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
  • In a patient with classic symptoms of hyperglycaemia or hyperglycaemic crisis, a random plasma glucose ≥200 mg/dL in the last 12 months.

You may not qualify if:

  • Any one of the following
  • History of diabetes onset \>12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin)
  • Any history suggestive of micro vascular or macro vascular disease
  • Women in childbearing age unable to practice any form of contraception
  • Impaired renal function; estimated glomerular filtration rate(eGFR) \<60mls/min/1.73m2.
  • Known history of any chronic illness taking regular pharmacological agents.
  • 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
  • Current or former employees of organic India
  • Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
  • Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital

Bangalore, Karnataka, 560099, India

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alben Sigamani, MD

    Narayana Hrudayalaya Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 15, 2016

Study Start

December 1, 2016

Primary Completion

December 15, 2017

Study Completion

January 15, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

IN(1)