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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Bangladesh
BSMMU
RECRUITING
Dhaka
Contact Information
Primary
Farzana Siddiqua, MBBS
farzanamony12@gmail.com
01842378736
Backup
Adhir K Das
01711961097
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2024-08-31
Participants
Target number of participants: 84
Treatments
Experimental: Nigella Sativa
Patients will receive Nigella Sativa (500mg) capsule twice daily for 8 weeks.
Placebo_comparator: Control
Patients will receive capsules of placebo twice daily for 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

This content was sourced from clinicaltrials.gov

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