Evaluation of Efficacy and Safety of Ceylon cinnamon in healthy adults
Phase 1
- Conditions
- Pharmacodynamic study
- Registration Number
- SLCTR/2013/001
- Lead Sponsor
- niversity of Colombo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Healthy human volunteers between 18 – 60 years of age
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Side effects and toxicity of Ceylon cinnamon<br><br>The following investigations would be performed for safety assessment;<br>Full Blood Count (FBC)<br>Renal function test (serum creatinine)<br>Liver function test (AST/ALT and bilirubin) and PT/INR <br>Urinalysis (UFR) [At baseline and monthly for a period of 3 months]<br>
- Secondary Outcome Measures
Name Time Method Appetite (using a 5 point visual analogue scale) [At baseline and monthly for a period of 3 months]<br> Diet (using a standardized food frequency questionnaire) [At baseline and monthly for a period of 3 months ]<br>Anthropometric measurements taken: height, weight, BMI, Waist circumference and hip circumference [At baseline and monthly for a period of 3 months ]<br>Serum lipid profile (Total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) [At baseline and monthly for a period of 3 months ]<br>Fasting blood glucose [At baseline and monthly for a period of 3 months ]<br>Blood pressure<br> [At baseline and monthly for a period of 3 months ]<br>