NCT03143803

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable diabetes-mellitus

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

May 2, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2017

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

September 5, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

May 2, 2017

Last Update Submit

September 1, 2017

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mean estimated glycated hemoglobin

    14 days

  • Number of hypoglycemia episodes

    14 days

Study Arms (2)

Polyherbal

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
PlaceboDRUG

Similar looking inactive powder

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Fasting Plasma Glucose ≥100 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND
  • 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.

You may not qualify if:

  • Any one of the following
  • Patients on Insulin therapy.
  • Any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes.
  • Women in child bearing age unable to practice any form of contraception
  • Patients with diagnosis of Anemia (Hb\<11 g/dl in Female and \<13 g/dl in Male)
  • Impaired renal function; estimated estimated glomerular filtration rate \<60mls/min/1.73m2.
  • Known history of any chronic illness taking regular pharmacological agents.
  • 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
  • Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy
  • Current or former employees of organic India or any potential conflict of interest in participation
  • 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)

Mazumdar Shaw Medical Centre

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

    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

May 2, 2017

First Posted

May 8, 2017

Study Start

May 5, 2017

Primary Completion

August 14, 2017

Study Completion

August 30, 2017

Last Updated

September 5, 2017

Record last verified: 2017-09

Locations

IN(1)