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Original TRDS for trail "Effect of Cherukurinja (Gymnema sylvestre, sin: masbedda) on glycemic control and on selected biochemical and physiological parameters among patients with type 2 diabetes mellitus." created on Mar 08, 2016


SLCTR Registration Number

SLCTR/2016/007

Date of Registration

08 Mar 2016

The date of last modification

Mar 08, 2016

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Application Summary

Scientific Title of Trial

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

Public Title of Trial

Effect of Cherukurinja (Gymnema sylvestre, sin: masbedda) 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

EGSDM study (Effect of Gymnema sylvestre 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 effect of Cherukurinja (Gymnema sylvester) 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

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 five 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.
  1. Fasting plasma glucose (FPG)
  2. HbA1c
 [
  1. FPG: At baseline, end of 1st, 2nd and 3rd months and at the end of 6 months.
  2. HbA1c: At baseline, end of 3rd month and end of 6th month.
]
2.

HbA1c

 [

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

]

Secondary outcome(s)

1.
  1. Lipid profile
  2. Blood pressure
  3. Body weight
 [
  1. Lipid profile: at baseline, end of 3rd and 6th months
  2. Body weight and blood pressure: at baseline and end of 2nd, 3rd and 6th month.
]
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

2016-04-01

Anticipated end date

2017-03-31

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

None

Regulatory approvals


State of Ethics Review Approval

Status

Date of Approval

Approval number

Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:

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
siventhan99@sltnet.lk

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

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results