Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06422650

Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia

Led by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Updated on 2024-05-21

84

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of Nigella Sativa in 84 Hyperlipidaemic patients. Participants will be assessed at baseline and after 8 weeks of intervention. Subjects will be randomized to receive either Nigella Sativa 500 mg capsule daily or placebo capsule identical to Nigella Sativa twice daily for 8 weeks. Evaluation of lipid profile, SGPT, S.Creatinine will be before and after 8 weeks of intervention. Nigella Sativa related adverse events will be identified. Study outcome will establish safety and efficacy of Nigella Sativa in atorvastatin treated hyperlipidaemic patients

CONDITIONS

Official Title

Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed hyperlipidemic patient
  • Male or female patients
  • Patients with hyperlipidemia who also have ischemic heart disease, diabetes mellitus, or hypertension
  • Diagnosed dyslipidemia with any of the following: total cholesterol 200mg/dl or higher, LDL-C 140mg/dl or higher, triglycerides 150mg/dl or higher, or HDL less than 40mg/dl
Not Eligible

You will not qualify if you...

  • Patients with kidney problems or renal impairment
  • Patients with active liver disease
  • Patients with history of hypersensitivity to any statin medication
  • Pregnant women
  • Breastfeeding mothers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

BSMMU

Dhaka, Bangladesh, 1000

Actively Recruiting

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Research Team

F

Farzana Siddiqua, MBBS

CONTACT

A

Adhir K Das

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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