The beneficial effects of Cinnamon in controlling the blood glucose levels in diabetic patients

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2012/007
• Date of registration: 27/06/2012
• Primary sponsor: Mr. Mahinda Sakalasooriya
• Public title: The beneficial effects of Cinnamon in controlling the blood glucose levels in diabetic patients
• Scientific title: The effect of less thani>Cinnamomum zeylanicumless than/i> on Glycosylated Haemoglobin as an add-on therapy for diabetic patients
• Date of first enrolment: 1/8/2012
• Target sample size: 300 (150 for each arm)
• Recruitment status: Pending
• URL: http://www.slctr.lk/trial_details.asp?reg_id={FFC54768-3B77-4A87-8F3E-FEB3BCD37362}
• Study type: Interventional
• Study design: Diabetic patients who fulfil the selection criteria, from the diabetic clinic, Teaching Hospital, Peradeniya will be selected for the study.; 1.1. The dose finding study/pilot study; Patients will be given less thani>Cinnamomum zeylanicumless than/i> 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 less thani>Cinnamomum zeylanicumless than/i> 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).

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. Arjuna Medagama
• Affiliation: Consultant Physician and Senior Lecturer

• Name: Dr. A.M. Panduka Mahamithawa
• Affiliation: Probationary Lecturer

Key inclusion & exclusion criteria

Inclusion criteria: All patients with diabetes (International Classification of Diseases, 9th revision, code for diabetes) with a HbA1c of and#8805;7.0% on a laboratory blood draw during the last 6 months.
Exclusion criteria: Age less than18 yrs

Pregnancy

Known allergy to cinnamon

End stage renal disease

Cirrhosis



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Patients will be randomized to receive either the capsule containing the powdered less thani>Cinnamomum zeylanicumless than/i> or the placebo capsule in addition to current diabetic medication. Dose to be determined following the dose finding study.

Primary Outcome(s)

Change in HbA1c levels

Secondary Outcome(s)

1. Lipid profile

2. Urinary Micro albumin level

3. Liver Function test (SGOT,SGPT)

4. Renal function tests (serum creatinine, BU)

5. Blood glucose levels (Fasting Blood Glucose)

6. Baseline blood pressure

7. Clinical assessment of exercise tolerance (history and ECG)

Secondary ID(s)

None

Source(s) of Monetary Support

Ministry of Agriculture in their project of "Api Wawamu Rata Nagamu”