Home » Trials » SLCTR/2013/001
Evaluation of pharmacodynamic properties and the safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults
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SLCTR Registration Number
SLCTR/2013/001
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Evaluation of pharmacodynamic properties and the safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults
Public Title of Trial
Evaluation of Efficacy and Safety of Ceylon cinnamon in healthy adults
Disease or Health Condition(s) Studied
Pharmacodynamic study
Scientific Acronym
None
Public Acronym
None
Brief title
Studying efficacy and safety of Ceylon cinnamon
Universal Trial Number
UTN: U1111-1138-4119
Any other number(s) assigned to the trial and issuing authority
EC-12-157 (Ethics Review Committee, Faculty of Medicine, University of Colombo)
What is the research question being addressed?
What are the potential toxic effects and safety concerns of Cinnamomum zeylanicum (Ceylon cinnamon) in escalating doses when given to healthy volunteers?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Other
Study Phase
Phase 1
Intervention(s) planned
Study setting: Department of Pharmacology, Faculty of Medicine, University of Colombo Details of the interventional product: Oral capsules containing cinnamon (85,250, 500mg) once daily for 3 months in monthly escalating doses as given below 85mg 1st month 250mg 2nd month 500mg 3rd month
Inclusion criteria
Healthy human volunteers between 18 – 60 years of age
Exclusion criteria
Primary outcome(s)
|
1.
Side effects and toxicity of Ceylon cinnamon The following investigations would be performed for safety assessment; Full Blood Count (FBC) Renal function test (serum creatinine) Liver function test (AST/ALT and bilirubin) and PT/INR Urinalysis (UFR) |
[ At baseline and monthly for a period of 3 months ] |
Secondary outcome(s)
|
1.
Appetite (using a 5 point visual analogue scale) |
[ At baseline and monthly for a period of 3 months ] |
|
2.
Diet (using a standardized food frequency questionnaire) |
[ At baseline and monthly for a period of 3 months ] |
|
3.
Anthropometric measurements taken: height, weight, BMI, Waist circumference and hip circumference |
[ At baseline and monthly for a period of 3 months ] |
|
4.
Serum lipid profile (Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) |
[ At baseline and monthly for a period of 3 months ] |
|
5.
Fasting blood glucose |
[ At baseline and monthly for a period of 3 months ] |
|
6.
Blood pressure |
[ At baseline and monthly for a period of 3 months ] |
Target number/sample size
30
Countries of recruitment
Sri Lanka
Anticipated start date
2013-01-01
Anticipated end date
2015-12-31
Date of first enrollment
2014-01-26
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
University of Colombo
Regulatory approvals
Status
Approved
Date of Approval
2012-11-15
Approval number
EC-12-157
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Priyadarshani Galapatthy (MBBS, MD, MRCP, FCCP) ,
Senior Lecturer
Department of Pharmacology, Faculty of Medicine, University of Colombo
0112695300 ext. 195
0718655651
priyadarshani1232000@yahoo.com
Contact Person for Public Queries
Dr Priyanga Ranasinghe
Lecturer
Department of Pharmacology, Faculty of Medicine, University of Colombo
0714-039413
priyanga.ranasinghe@gmail.com
Primary study sponsor/organization
University of Colombo
University of Colombo, Colombo 07
0112581835
acpbuoc@gmail.com
http://www.cmb.ac.lk
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
