Pharmacodynamic study
Conditions
Interventions
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 i
Sponsors
University of Colombo
Eligibility
Inclusion criteria
Inclusion criteria: Healthy human volunteers between 18 – 60 years of age
Exclusion criteria
Exclusion criteria: 1. Alcohol consumption >20 g/day 2. Diagnosed Alcoholic Liver Disease (ALD), 3. Cirrhosis 4. Abnormal baseline liver, renal function tests or other haematological parameters. 5. Any chronic illness. 6. Any long term medication including any nutritional supplements. 7. Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child bearing years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Appetite (using a 5 point visual analogue scale) [At baseline and monthly for a period of 3 months] Diet (using a standardized food frequency questionnaire) [At baseline and monthly for a period of 3 months ] Anthropometric measurements taken: height, weight, BMI, Waist circumference and hip circumference [At baseline and monthly for a period of 3 months ] Serum lipid profile (Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) [At baseline and monthly for a period of 3 months ] Fasting blood glucose [At baseline and monthly for a period of 3 months ] Blood pressure [At baseline and monthly for a period of 3 months ] | — |
Countries
Sri Lanka
Contacts
Public ContactDr Priyadarshani Galapatthy (MBBS, MD, MRCP, FCCP) ,
Senior Lecturer
Outcome results
None listed