Effect of Curcumin on Systemic Lupus Erythematosus

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.

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Curcumin supplement

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Curcumin supplement; Intervention is 2 grams of curcumin supplement per day
Experimental: Curcumin	Drug: Curcumin supplement; Intervention is 2 grams of curcumin supplement per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SLEDAI	Number of participants with change in SLEDAI by 2 points by Day 90	90 days

Collaborators and Investigators

• Sponsor: Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): April 13, 2022
• Study Completion (Actual): April 13, 2022

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 5190041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No