Home » Trials » SLCTR/2016/007


Supplement effect of Cherukurinja (Gymnema lactiferum) on glycemic control and on selected biochemical and physiological parameters among patients with type 2 diabetes mellitus.

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SLCTR Registration Number

SLCTR/2016/007


Date of Registration

08 Mar 2016

The date of last modification

Jan 29, 2019


View original TRDS


Trial Status



Application Summary


Scientific Title of Trial

Supplement effect of Cherukurinja (Gymnema lactiferum) on glycemic control and on selected biochemical and physiological parameters among patients with type 2 diabetes mellitus.


Public Title of Trial

Supplement effect of Cherukurinja (Gymnema lactiferum) on glycemic control and on selected biochemical and physiological parameters among patients with type 2 diabetes mellitus.


Disease or Health Condition(s) Studied

Type 2 diabetes mellitus


Scientific Acronym

SEGLDM study ( Supplement effect of Gymnema lactiferum on Diabetes Mellitus)


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1177-0604


Any other number(s) assigned to the trial and issuing authority

ERC (Jaffna): J/ERC/15/66/NDR/0133


Trial Details


What is the research question being addressed?

What is the supplement effect of Cherukurinja (Gymnema lactiferum) on glycemic control and on selected biochemical and physiological parameters such as lipid profile, blood pressure and body weight among patients with type 2 diabetes mellitus?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Active


Assignment

Parallel


Purpose

Basic science


Study Phase

Not Applicable


Intervention(s) planned

The study will be carried out at the Diabetic Centre, Teaching Hospital Jaffna.

The first patient will be selected by lottery from the first four patients according to the clinic numbers and then every fifth patient will be selected for screening. Consenting patients meeting the inclusion/exclusion criteria will be randomized into the intervention and control arms.

Intervention arm: One cup of herbal tea, made from 1.5 gram Cherukurinja dry leaf powder tea bag, once in a day for three months.

Control arm: One cup of green tea, made from 1.5 gram green tea bag, once in a day for three months. Standard anti-diabetic medication will be continued for all patients, in accordance with clinic protocols.

Double blinding will be ensured as the participants will be treatment naive (not exposed to either Cherukurinja or green tea) and the outcomes will be assessed by investigators who will be blind to the treatment status.


Inclusion criteria

  1. Adult patients aged 18 years and above diagnosed with type 2 diabetes (according to WHO criteria)
  2. Controlled on oral anti-diabetic medication

Exclusion criteria

  1. Patients on any medication known to affect glycaemic control (e.g. thiazide diuretics, steroids, oral contraceptive pill, frusemide, beta blockers etc.)
  2. End stage organ failure
  3. Diagnosed psychiatric illness
  4. Pregnancy
  5. Breast feeding
  6. Patients who have already taken either Cherukurinja Herbal Tea or Green Tea or both in the past


Primary outcome(s)

  1. Fasting plasma glucose (FPG)

    [

    FPG: At baseline, end of 1st, 2nd and 3rd months and at the end of 6 months.

    ]
  2. HbA1c

    [

    HbA1c: At baseline, end of 3rd month and end of 6th month.

    ]

Secondary outcome(s)

  1. Lipid profile

    [

    At baseline, end of 3rd and 6th months

    ]
  2. Blood pressure

    [

    At baseline and end of 2nd, 3rd and 6th month.

    ]
  3. Body weight

    [

    At baseline and end of 2nd, 3rd and 6th month.

    ]

Target number/sample size

320 (160 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-09-01


Anticipated end date

2019-10-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None (Investigator funded)


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2016-01-11


Approval number

J/ERC/15/66/NDR/0133 (Last extension: 25.07.2018)


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Jaffna
Institutional Address: ERC Office, Faculty of Medicine, University of Jaffna, Adiyapatham Road, Kokuvil, Jaffna Sri Lanka
Telephone: +94-212222073 (Extension: 342)
Email: ercmedjfn@gmail.com


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Karthigesu Kulanayagam
Medical Officer
Outpatient Department, Teaching Hospital, Jaffna, Sri Lanka.
Tel: 0094 21 222 2301-3
Mob: 0094 77 8052520
Fax: 021 222 2262
kulanayagam@gmail.com

Contact Person for Public Queries

Dr. S. Sivansuthan MBBS (Cey), MD (Cey)
Visiting Physician
Teaching Hospital, Jaffna, Sri Lanka.
Tel: 0094 21 222 2301-3
Mob: 0094 777916231
Fax: 021 222 2262
drsivansuthan@gmail.com


Primary study sponsor/organization

Teaching Hospital Jaffna

Jaffna, Sri Lanka
Tel: 0094 21 222 2301-3
Fax: 021 222 2262

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results