Effect of Curcumin on Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Effect of Curcumin on Systemic Lupus Erythematosus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03953261
• Other study ID #: 5190041
• Status: Terminated
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: April 13, 2022

Study information

• Verified date: August 2022
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: April 13, 2022
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Curcumin supplement
Intervention is 2 grams of curcumin supplement per day

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in SLEDAI	Number of participants with change in SLEDAI by 2 points by Day 90	90 days