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Effect of Curcumin on Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Curcumin supplement
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curcumin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 14, 2019
Last Updated
August 3, 2022
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT03953261
Brief Title
Effect of Curcumin on Systemic Lupus Erythematosus
Official Title
Effect of Curcumin on Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID and lack of support staff 2. lack of support staff to conduct the study
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
April 13, 2022 (Actual)
Study Completion Date
April 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Curcumin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Curcumin supplement
Intervention Description
Intervention is 2 grams of curcumin supplement per day
Primary Outcome Measure Information:
Title
Change in SLEDAI
Description
Number of participants with change in SLEDAI by 2 points by Day 90
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Curcumin on Systemic Lupus Erythematosus

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