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Effect of Curcumin on Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03953261
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Vaneet Sandhu, Loma Linda University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Curcumin supplement Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Curcumin on Systemic Lupus Erythematosus
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Curcumin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Curcumin Drug: Curcumin supplement
Intervention is 2 grams of curcumin supplement per day
Placebo Comparator: Placebo Drug: Curcumin supplement
Intervention is 2 grams of curcumin supplement per day


Outcome Measures
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Primary Outcome Measures :
  1. Change in SLEDAI [ Time Frame: 90 days ]
    Number of participants with change in SLEDAI by 2 points by Day 90


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953261


Contacts
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Contact: Vaneet Sandhu, MD 909.558.4911 vksandhu@llu.edu
Contact: Micah Yu, MD 909.558.4911 micyu@llu.edu

Locations
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United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
More Information
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Responsible Party: Vaneet Sandhu, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT03953261    
Other Study ID Numbers: 5190041
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action