Home » Trials » SLCTR/2015/011
The efficacy of Costus speciosus leaves on the postprandial glucose surge in healthy subjects; a clinical trial
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SLCTR Registration Number
SLCTR/2015/011
Date of Registration
The date of last modification
Jul 09, 2019
Scientific Title of Trial
The efficacy of Costus speciosus leaves on the postprandial glucose surge in healthy subjects; a clinical trial
Public Title of Trial
The efficacy of Costus speciosus (Thebu) leaves to reduce postprandial blood glucose in healthy subjects.
Disease or Health Condition(s) Studied
Blood glucose response to commonly consumed herb
Scientific Acronym
None
Public Acronym
None
Brief title
Costus speciosus and blood glucose
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
2014/EC/64 (University of Peradeniya)
What is the research question being addressed?
Does the commonly consumed herb Costus speciosus (Thebu) in its usually consumed manner lower the blood glucose levels following ingestion?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Placebo
Assignment
Parallel
Purpose
Basic science
Study Phase
Phase 1
Intervention(s) planned
The subjects will be recruited from the staff of the University of Peradeniya. The Principle investigator will approach eligible subjects and inform and screen them. Subjects will be randomized using computer generated numbers to control or trial arms with concealed allocation.
20g of measured Costus leaves will be given in a salad preparation and the quantity served will be standardized and uniform.
The controls will receive a meal in similar calorie content and will contain the placebo in the form of “ Kathuru murunga” (Sesbania grandiflora) leaves
The meals will be supervised by the Nutritionist at the Teaching Hospital Peradeniya. A plasma glucose measurement will be taken prior to administration of the meal.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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1.
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[
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Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
50
Countries of recruitment
Sri Lanka
Anticipated start date
2015-06-01
Anticipated end date
2015-08-15
Date of first enrollment
Date of study completion
Recruitment status
Withdrawn
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2014-11-13
Approval number
2014/EC/64
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Arjuna Medagama
Senior Lecturer in Medicine
Department of Medicine
Faculty of Medicine
University of Peradeniya
Sri Lanka
+94812396470
arjunam@pdn.ac.lk
Contact Person for Public Queries
Arjuna
Medagama
Department of Medicine
Faculty of Medicine
University of Peradeniya
Sri Lanka
+94812396470
arjunam@pdn.ac.lk
Primary study sponsor/organization
Department of Medicine
Faculty of Medicine
University of Peradeniya
Sri Lanka
Tel: 081-2388840
Fax: 081-2389106
arjunam@pdn.ac.lk
http://www.pdn.ac.lk/med/departments/ medicine/index.html
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
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
