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Effect of Curcumin on Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT03953261
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
Change in SLEDAI [ Time Frame: 90 days ]
Number of participants with change in SLEDAI by 2 points by Day 90
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
Decrease in SLEDAI [ Time Frame: 90 days ]
Decrease in SLEDAI by 2 points by Day 90
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Curcumin on Systemic Lupus Erythematosus
Official Title  ICMJE Effect of Curcumin on Systemic Lupus Erythematosus
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Drug: Curcumin supplement
Intervention is 2 grams of curcumin supplement per day
Study Arms  ICMJE
  • Experimental: Curcumin
    Intervention: Drug: Curcumin supplement
  • Placebo Comparator: Placebo
    Intervention: Drug: Curcumin supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
68
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2022
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vaneet Sandhu, MD 909.558.4911 vksandhu@llu.edu
Contact: Micah Yu, MD 909.558.4911 micyu@llu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953261
Other Study ID Numbers  ICMJE 5190041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Loma Linda University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP