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SLCTR Registration Number
SLCTR/2013/001
Date of Registration
The date of last modification
Jul 22, 2015
View original TRDS
Trial Status
Scientific Title of Trial
Evaluation of Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for Diabetes Mellitus
Public Title of Trial
Effect of Ceylon Cinnamon on diabetes
Disease or Health Condition(s) Studied
Type 2 Diabetes Mellites
Scientific Acronym
None
Public Acronym
None
Brief title
Using Ceylon cinnamon in Diabetes Mellitus
Universal Trial Number
UTN: U1111-1138-4119
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 1-2
Intervention(s) planned
Inclusion criteria
Stage I 1.Age 18 years – 60 years 2. Diagnosed type 2 diabetes mellitus for less than 5 years on not more than two oral hypoglycemic agents Stage II Healthy adults between 18 – 50 years of age
Exclusion criteria
Stage I a. Alcohol consumption > 20 g/day, patients with Alcoholic Liver Disease (ALD), patients with cirrhosis and abnormal baseline liver function tests. b. Patients with raised baseline serum creatinine level. c. Patients on insulin therapy at baseline. d. Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child bearing years
Stage II a. Alcohol consumption >20 g/day, patients with Alcoholic Liver Disease (ALD), b. Patients with cirrhosis and abnormal baseline liver, renal function tests or blood counts. c. Patient with any chronic illness. d.Patient on any long term medication including any nutritional supplements. e.Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child bearing years
Primary outcome(s)
|
1.
Stage I - Fasting blood glucose, OGTT, serum insulin, serum HbA1c Stage II - Toxic effect of Ceylon cinnamon.- Liver profile, renal profile |
[ Stage I - at baseline and at 12 months Stage II - at baseline and at 3 months ] |
Secondary outcome(s)
|
1.
Stage I 1. Serum lipid profile 2. Blood pressure 3. Appetite, diet and anthropometric measurements 4. Liver profile and renal profile 5. Physical activity Stage II 1. Appetite, diet and anthropometric measurements 2. Serum lipid profile 3. Fasting blood glucose 4. Blood pressure |
[ Stage I - 0,1,3,6 and 12 months Stage II - monthly ] |
|
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
Stage I - 240, Stage II - 30
Countries of recruitment
Sri Lanka
Anticipated start date
2013-01-01
Anticipated end date
2014-06-30
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
University of Colombo
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
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
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
