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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: SLCTR
Last refreshed on: 27 April 2013
Main ID:  SLCTR/2009/004
Date of registration: 15/05/2009
Primary sponsor: Dr. Aruna Munasinghe
Public title: Effect of a herbal compound on blood sugar level
Scientific title: A clinical trial to assess the efficacy of coccinia grandis (kem) leaves as a hypoglycaemic agent in healthy individuals
Date of first enrolment: 1/5/2009
Target sample size: 200
Recruitment status: Completed
URL:  http://www.slctr.lk/trial_details.asp?reg_id={5CBADBAE-83AC-4D05-A5D9-B6A44A8C2DA5}
Study type:  Interventional
Study design:  Double blind phase 11 clinical trial  
Countries of recruitment
Sri Lanka
Contacts
Name: Dr. Aruna Munasinghe 
Address:  General Hospital, Matara
Telephone: 0777481296
Email: draruna@hotmail.com
Affiliation:  Consultant Physician
Name: Dr. Aruna Munasinghe 
Address:  General Hospital, Matara
Telephone: 0777481296
Email: draruna@hotmail.com
Affiliation:  Consultant Physician
Key inclusion & exclusion criteria
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


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Diabetes mellitus
Intervention(s)
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.
Primary Outcome(s)
Blood sugar levels after one hour and two hours of administration and 75 grams of glucose
Secondary Outcome(s)
Reporting side effects
Secondary ID(s)
None
Source(s) of Monetary Support
Self
Secondary Sponsor(s)
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