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
The date of last modification
Feb 07, 2025
View original TRDS
Trial Status
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
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
Exclusion criteria
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
2019-10-16
Date of study completion
2022-12-10
Recruitment status
Complete: follow up complete
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
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 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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Yes
Date of posting results
2024-09-01
Date of study completion
2022-12-10
Final sample size
320
Date of first publication
2024-09-01
Link to results
Brief summary of results
Background: Gymnema lactiferum is an edible leafy vegetable plant in the family of Apocynaceae. It has been used to control diabetes in the northern part of Sri Lanka for several decades and used as a leaf vegetable from the ancient period. However, this plant was not clinically tested for its claimed antidiabetic properties. Therefore, this study was conducted in Teaching Hospital Jaffna to establish the efficacy of the plant. Objective: The objective of this parallel arm, double-blind randomised controlled phase III trial is to establish the efficacy and safety of Gymnema lactiferum. Methods: Eligible type 2 diabetes mellitus (T2DM) patients at the Diabetic Centre, Teaching Hospital Jaffna, Sri Lanka were randomly allocated to treatment (n = 160) and control (n = 160) arms. The treatment arm received a tea brew made of G. lactiferum dried leaves (1.5 g in 200 mL of hot water) while the control arm received green tea (1.5 g in 200 mL of hot water) daily for 3 months. The patients in both arms were reviewed at the baseline and the end of 1st, 3rd and 6th months for FPG, HbA1c, blood pressure, body weight and lipid profiles. Results: Statistically significant reductions in HbA1c (treatment arm: -0.47 %, P = 0.0000; control arm -0.26 %, P = 0.0009) and FPG (the control arm: ?0.42 mmol/L, P = 0.0388) from the base values were observed at the end of the 3rd month. In the subgroup analysis that evaluated the participants with poorly controlled glycemia (HbA1c ?8), which accounted for over 52 % of all participants, a clinically significant reduction in HbA1c was observed in the treatment and control arms (-0.90 %; P = 0.0000 and -0.71 %; P = 0.0000). Post-intervention analysis revealed a long-lasting significant reduction in HbA1c in both arms. Further, significant reductions in blood pressure and lipid profile were also noted at the end of the third month and post-intervention period. Conclusion: G. lactiferum tea significantly reduced HbA1c in uncontrolled T2DM patients and the effect observed was superior to green tea. Long-term treatment is needed to determine the clinical implications of the effects on blood pressure, body weight and lipid levels and to confirm the safety.
