Effect of Curcumin on Systemic Lupus Erythematosus

Phase 2

Terminated

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Curcumin supplement

• Registration Number: NCT03953261
• Lead Sponsor: Loma Linda University

Brief Summary

The purpose of this investigator initiated study is to determine the efficacy of curcumin on disease activity of subjects with systemic lupus erythematous. Curcumin has been found to have anti-inflammatory effects and has been found to improve disease activity in lupus patients. In addition, subjects with rheumatoid arthritis as well as osteoarthritis have also found benefit for their disease activity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Study Start: 2019-09-01
• Primary Completion: 2022-04-13
• Study Completion: 2022-04-13
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 or older
• Diagnosed with Systemic Lupus Erythematous according to the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria.
• SLEDAI score of 6 or higher
• Ability to take oral medication and be willing to adhere to the study drug regimen

Exclusion Criteria

• Inability to provide written consent for study participation
• Use of curcumin supplements within 30 days of enrollment of study
• Liver function disorders (AST/ALT > 2.5x upper limit of normal)
• Pregnancy or lactation
• Known allergic reactions to turmeric
• Subjects who are admitted for recent hospitalization within past 60 days
• Treatment with another investigational drug or other intervention within past 60 days
• Subjects with end stage renal disease on dialysis
• Subjects who lack the ability to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin	Curcumin supplement	-
Placebo	Curcumin supplement	-

Primary Outcome Measures

Name	Time	Method
Change in SLEDAI	90 days	Number of participants with change in SLEDAI by 2 points by Day 90

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States