Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia
Launched by BANGABANDHU SHEIKH MUJIB MEDICAL UNIVERSITY, DHAKA, BANGLADESH · May 20, 2024
Trial Information
Current as of February 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a natural supplement called Nigella Sativa in patients who have high cholesterol levels (a condition known as hyperlipidemia) and are already taking a medication called atorvastatin. The study will last for 8 weeks and will involve 84 participants. Half of the participants will receive daily capsules of Nigella Sativa, while the other half will receive a placebo, which looks the same but contains no active ingredients. Researchers will check the participants' cholesterol and liver function before and after the trial to see if Nigella Sativa is safe and effective for these patients.
To be eligible for this trial, participants must be newly diagnosed with hyperlipidemia and can include both men and women aged between 65 and 74 years. They should also have conditions like heart disease, diabetes, or high blood pressure. However, those with kidney or liver problems, a history of allergic reactions to statins, pregnant women, or nursing mothers cannot participate. Participants can expect to have their health monitored during the study and will play a vital role in helping researchers understand if Nigella Sativa can benefit people with high cholesterol.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Newly diagnosed hyperlipidaemic patient.
- • 2. Both male and female
- • 3. Hyperlipidemic patients suffering from ischemic heart disease, diabetes mellitus, hypertension
- • 4. Diagnostic criteria for dyslipidemic patients
- • 1. Total cholesterol 200mg/dl
- • 2. LDL-C 140mg/dl
- • 3. Triglyceride 150mg/dl
- • 4. HDL \<40mg/dl
- Exclusion Criteria:
- • 1. Patients with renal impairment
- • 2. Patients with active liver disease
- • 3. Patients having history of hypersensitivity on any member of statins
- • 4. Pregnant woman.
- • 5. lactating mother
Trial Officials
Farzana Siddiqua, MBBS
Principal Investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka, Bangladesh, is a premier institution dedicated to advancing medical education, research, and healthcare services. As a leading clinical trial sponsor, BSMMU is committed to fostering innovative research initiatives that enhance patient care and contribute to the global medical community. The university boasts a multidisciplinary team of experts and state-of-the-art facilities, enabling the conduct of rigorous clinical trials across various therapeutic areas. With a focus on ethical standards and patient safety, BSMMU aims to facilitate the development of new treatments and improve health outcomes both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dhaka, , Bangladesh
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0