Home » Trials » SLCTR/2012/007
The effect of Cinnamomum zeylanicum on Glycosylated Haemoglobin as an add-on therapy for diabetic patients
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SLCTR Registration Number
SLCTR/2012/007
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
The effect of Cinnamomum zeylanicum on Glycosylated Haemoglobin as an add-on therapy for diabetic patients
Public Title of Trial
The beneficial effects of Cinnamon in controlling the blood glucose levels in diabetic patient
Disease or Health Condition(s) Studied
Diabetes Mellites
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
2011/EC/38 (Ethics Review Committee of Faculty of Medicine, University of Peradeniya)
What is the research question being addressed?
Does ingestion of Cinnamomum zeylanicum as an add-on therapy to the current drug regime reduce HbA 1c in diabetic patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 1-2
Intervention(s) planned
1.1. The dose finding study/pilot study Patients will be given Cinnamomum zeylanicum dry powder orally as a capsule in addition to their current treatment. The most effective dose with minimum adverse effects will be determined by a dose finding study, which the patients will receive 300 mg, 750 mg and 1 g of powdered Cinnamomum zeylanicum in three groups. Patients will be monitored for a maximum duration of two weeks and blood samples will be analysed in every 6 hours’ time. The number of patients for each group will be around 6 to 10.
1.2. Randomized controlled clinical trial The study will be an open label randomized controlled clinical trial (RCT).Patients will be randomized to receive either the capsule containing the powdered Cinnamomum zeylanicum or the placebo capsule in addition to current diabetic medication. Dose to be determined following the dose finding study.
Inclusion criteria
All patients with diabetes (International Classification of Diseases, 9th revision, code for diabetes) with a HbA1c of =/>7.0% on a laboratory blood draw during the last 6 months.
Exclusion criteria
Age <18 yrs Pregnancy Known allergy to cinnamon End stage renal disease Cirrhosis
Primary outcome(s)
|
1.
Change in HbA1c level |
[ At baseline and every 3 months for a total of 15 months per patient ] |
Secondary outcome(s)
|
1.
Lipid profile |
[ At baseline and every 3 months ] |
|
2.
Urinary Micro albumin level |
[ At baseline and every 6 months ] |
|
3.
Liver Function test (SGOT,SGPT) |
[ At baseline and every 3 months ] |
|
4.
Renal function tests (serum creatinine, BU) |
[ At baseline and every 3 months ] |
|
5.
Blood glucose levels (Fasting Blood Glucose) |
[ At baseline and monthly (For a total of 15 months) ] |
|
6.
Baseline blood pressure |
[ At baseline and monthly (For a total of 15 months) ] |
|
7.
Clinical assessment of exercise tolerance (history and ECG) |
[ At baseline and monthly (For a total of 15 months) ] |
Target number/sample size
300 (150 for each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2012-08-01
Anticipated end date
2015-07-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Ministry of Agriculture in their project of "Api Wawamu Rata Nagamu”
Regulatory approvals
Status
Approved
Date of Approval
2012-03-15
Approval number
2011/EC/38
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
Dr. A.M. Panduka Mahamithawa
Probationary lecturer
Department of Pharmacology, Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka,Saliyapura, Anuradhapura
+94-81-4479822
+94-718-099711
mahamithawa2000@yahoo.com
Contact Person for Public Queries
Dr. Arjuna Medagama
Consultant Physician and Senior Lecturer
Department of Medicine Faculty of Medicine, University of Peradeniya
+94-81-2396470 +94-81-2389106
arjuna.medagam@gmail.com
Primary study sponsor/organization
Mr. Mahinda Sakalasooriya
Project Coordinator & Research Officer, Sri Lanka Council for Agriculture Research Policy
114/9, Wijerama Mawatha, Colombo 07.
011-2697103, 0715676016 011-2682951
mahindass@gmail.com
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
