Trials
Search / Trial NCT06422650

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.

Locations

Dhaka, , Bangladesh

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0