RecruitingPhase 2NCT06422650

Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia

Effect of Nigella Sativa on Blood Lipids as an add-on Therapy in Atorvastatin Treated Hyperlipidaemic Patients. A Randomized Controlled Trial


Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Enrollment

84 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

  • Newly diagnosed hyperlipidaemic patient.
  • Both male and female
  • Hyperlipidemic patients suffering from ischemic heart disease, diabetes mellitus, hypertension
  • Diagnostic criteria for dyslipidemic patients
  • Total cholesterol 200mg/dl
  • LDL-C 140mg/dl
  • Triglyceride 150mg/dl
  • HDL <40mg/dl

Exclusion Criteria5

  • Patients with renal impairment
  • Patients with active liver disease
  • Patients having history of hypersensitivity on any member of statins
  • Pregnant woman.
  • lactating mother

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Interventions

DRUGNigella Sativa capsule 500mg

Nigella Sativa capsule 500mg twice daily for 8 weeks

DRUGPlacebo

Oral placebo identical to astaxanthin


Locations(1)

BSMMU

Dhaka, Bangladesh

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NCT06422650


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