Home » Trials » SLCTR/2017/010
Effectiveness of Cinnamomum zeylanicum (Ceylon cinnamon) in lowering blood glucose in type 2 diabetes mellitus: a Randomized Double Blind Placebo Controlled Clinical Trial
-
SLCTR Registration Number
SLCTR/2017/010
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effectiveness of Cinnamomum zeylanicum (Ceylon cinnamon) in lowering blood glucose in type 2 diabetes mellitus: a Randomized Double Blind Placebo Controlled Clinical Trial
Public Title of Trial
Effect of Ceylon cinnamon in lowering blood glucose for type 2 diabetes mellitus
Disease or Health Condition(s) Studied
Type 2 Diabetes Mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
Ceylon cinnamon in type 2 diabetes
Universal Trial Number
U1111-1194-6431
Any other number(s) assigned to the trial and issuing authority
EC-16-197 (ERC: Colombo)
What is the research question being addressed?
Does Ceylon cinnamon lower blood glucose in patients with type 2 Diabetes Mellitus?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
The study will be carried out at Medical Clinics of the University Medical Unit, National Hospital of Sri Lanka.
Consenting participants meeting inclusion/exclusion criteria will be randomized into 3 arms using stratified block randomization.
Arm 1 (intervention arm) will receive a capsule containing 250mg Cinnamomum zeylanicum extract as the active ingredient, to be taken orally once daily before breakfast for a period of 4 months.
Arm 2 (intervention arm) will receive a capsule containing 500mg Cinnamomum zeylanicum extract as the active ingredient, to be taken orally once daily before breakfast for a period of 4 months.
Arm 3 (control arm) will receive an identical matching placebo. The placebo will be manufactured to have a similar appearance, shape, weight, and color as the cinnamon capsules
The investigators and patients would be blind to the treatment allocations.
Standard management will continue for participants in all 3 arms.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change in HbA1c from baseline in treatment and placebo arms |
[ At baseline and monthly for a period of four months. ] |
|
2.
Change in Fasting Blood Glucose (FBG) from baseline in treatment and placebo arms |
[ At baseline and monthly for a period of four months. ] |
Secondary outcome(s)
|
1.
Percentage of patients with HbA1c <7.0% |
[ At baseline and monthly for a period of four months. ] |
|
2.
Percentage of patients with FBG < 126 mg/dl |
[ At baseline and monthly for a period of four months. ] |
|
3.
Change in insulin resistance and Beta-cell function from baseline (measured by the Homeostasis Model of Assessment (HOMA) calculations based on fasting blood glucose and fasting serum insulin). |
[ At baseline and monthly for a period of four months. ] |
|
4.
Change in BMI and other anthropometric parameters (weight, waist circumference, hip circumference, waist:hip ratio) from baseline |
[ At baseline and monthly for a period of four months. ] |
|
5.
Change in Blood Pressure (systolic and diastolic) from baseline |
[ At baseline and monthly for a period of four months. ] |
|
6.
Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline |
[ At baseline and monthly for a period of four months. ] |
Target number/sample size
210 (70 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-05-01
Anticipated end date
2017-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University of Colombo (Grant ref. no. AP/03/2012/CG/08)
Regulatory approvals
Status
Approved
Date of Approval
2017-03-23
Approval number
EC-16-197
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
Prof. Priyadarshani Galappatthy
Professor in Pharmacology
Department of Pharmacology,
Faculty of Medicine,
University of Colombo,
No 25, Kynsey Road,
Colombo 08, Sri Lanka
Tel: 0112695300
Mob: 0718655651
p.galappatthy@pharm.cmb.ac.lk
http://med.cmb.ac.lk/index.php/department-of-parmacol-staff?id=264
Contact Person for Public Queries
Dr. Priyanga Ranasinghe
Lecturer
Department of Pharmacology,
Faculty of Medicine,
University of Colombo,
No 25, Kynsey Road,
Colombo 08, Sri Lanka
Tel: 0112695300
Mob: 0772770202
priyanga@pharm.cmb.ac.lk
http://med.cmb.ac.lk/index.php/department-of-parmacol-staff?id=269
Primary study sponsor/organization
University of Colombo
Kumaratunga Munidasa Mawatha,
Colombo 03
Sri Lanka
Tel: 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
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
