Systemic Lupus Erythematosus
Conditions
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.
Interventions
DRUGCurcumin supplement
Intervention is 2 grams of curcumin supplement per day
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SLEDAI | 90 days | Number of participants with change in SLEDAI by 2 points by Day 90 |
Countries
United States
Outcome results
None listed