Effect of Curcumin on Systemic Lupus Erythematosus

NCT03953261 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 5190041
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Change in SLEDAI

  Number of participants with change in SLEDAI by 2 points by Day 90

  90 days

Study Arms (2)

Curcumin

EXPERIMENTAL

Drug: Curcumin supplement

Placebo

PLACEBO COMPARATOR

Drug: Curcumin supplement

Interventions

Curcumin supplement DRUG

Intervention is 2 grams of curcumin supplement per day

Curcumin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: September 1, 2019
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)