Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia

NCT06422650 | Recruiting Phase 2

• 1 other identifier: BSMMU/2023/11004
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Change in blood lipids

  84 atorvastatin treated hyperlipidaemic patients will randomly receive 8 weeks oral twice daily course of either Nigella Sativa 500 mg capsule or placebo.Change in blood lipids will be measured by spectrophotometer.

  8 weeks

Study Arms (2)

Nigella Sativa

EXPERIMENTAL

Patients will receive Nigella Sativa (500mg) capsule twice daily for 8 weeks.

Drug: Nigella Sativa capsule 500mg

Control

PLACEBO COMPARATOR

Patients will receive capsules of placebo twice daily for 8 weeks.

Drug: Placebo

Interventions

Nigella Sativa capsule 500mg DRUG

Nigella Sativa capsule 500mg twice daily for 8 weeks

Also known as: Black seed oil

Nigella Sativa

Placebo DRUG

Oral placebo identical to astaxanthin

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Farzana Siddiqua, MBBS

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farzana Siddiqua, MBBS

CONTACT

01842378736; farzanamony12@gmail.com

Adhir K Das

CONTACT

01711961097

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, MD, Pharmacology

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: August 24, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)