Home » Trials » SLCTR/2009/004
A clinical trial to assess the efficacy of Coccinia grandis (kem) leaves as a hypoglycaemic agent in healthy individuals
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SLCTR Registration Number
SLCTR/2009/004
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A clinical trial to assess the efficacy of Coccinia grandis (kem) leaves as a hypoglycaemic agent in healthy individuals
Public Title of Trial
Effect of a herbal compound on blood sugar level
Disease or Health Condition(s) Studied
Diabetes Mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P11/03/2009 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Is Coccinia grandis has a effect on lowering blood sugar level?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Double blinded
Control
Uncontrolled
Assignment
Single
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
20 grams of Coccinia grandis (kem) is mixed with measured amounts of scraped coconut and table salts. Each sample is prepared in a similar manner.Coccinia grandis is a commonly used and available herbal plant and people consume it as a component and no known adverse reactions were reported.
Inclusion criteria
All the healthy volunteers who are having their fasting blood sugar level within the normal range according to WHO criteria between 18-55
Exclusion criteria
Participants outside the above range, Pregnant mothers
Primary outcome(s)
|
1.
Blood sugar levels after one hour and two hours of administration and 75 grams of glucose |
[ After one hour and two hours ] |
Secondary outcome(s)
|
1.
Reporting side effects |
[] |
Target number/sample size
200
Countries of recruitment
Sri Lanka
Anticipated start date
2009-05-01
Anticipated end date
2009-09-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2009-03-03
Approval number
P11/03/2009
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Aruna Munasinghe
Consultant Physician
General Hospital, Matara
0777481296
draruna@hotmail.com
Contact Person for Public Queries
Dr. Aruna Munasinghe
Consultant Physician
General Hospital, Matara
0777481296
draruna@hotmail.com
Primary study sponsor/organization
Dr. Aruna Munasinghe
General Hospital, Matara
0777481296
draruna@hotmail.com
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
