Randomized, double blinded placebo-controlled trial to determine the effect of Cinnamon extract on serum cholesterol levels in people with serum LDL level between 100 mg/dL – 190 mg/dL (100 mg/dL<LDL<190 mg/dL).
- Conditions
- Serum LDL level between 100 mg/dL – 190 mg/dL (100 mg/dL<LDL<190 mg/dL)
- Registration Number
- SLCTR/2021/011
- Lead Sponsor
- SDS Spices (PVT) LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
* Age between 18-70 years
* Both male and female
* LDL level; between 100 and 190 mg/dL (100 mg/dL < LDL < 190mg/dL)
• Participants with an allergy to cinnamon
• Already on cinnamon or any other nutritional / herbal / ayurvedic supplements.
• Lactation, pregnancy or unwillingness to use an effective form of birth control for women of childbearing years
• Any form of malignancy at present or in the past
• Blood dyscrasias
• Estimated Glomerular Filtration Rate (eGFR) <30ml/min
• Patients with diagnosed alcoholic liver disease (ALD), decompensated cirrhosis or abnormal baseline liver function tests (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) - Above three times the upper limit of normal)
• Patients with cardiac, liver, renal or respiratory failure
• Patients with Atherosclerotic Cardiovascular Disease (ASCVD) or any other major critical illnesses.
- This may include any illness, which is certified by the investigator to be a serious illness. For
example
a. Chronic lung disease
b. Severe psychiatric or mental illness
c. Severe blood disorders
• Any condition that, in the opinion of the primary investigator, would contraindicate the patient’s participation.
• Currently on statins or any other lipid lowering drug or if investigator decides that the participant is in need of an immediate lipid lowering therapy (statin) based on clinical judgement.
• Participant with triglycerides level >300 mg/dL
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in low density lipo-protein (LDL) levels from baseline to final follow-up at three months post randomization. [end of 3 months ]<br>
- Secondary Outcome Measures
Name Time Method