Effect of Curcumin on Systemic Lupus Erythematosus
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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 : May 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Drug: Curcumin supplement | Phase 2 |
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, 2022 |
Estimated Study Completion Date : | May 1, 2022 |

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 |
- Change in SLEDAI [ Time Frame: 90 days ]Number of participants with change in SLEDAI by 2 points by Day 90

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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
Contact: Vaneet Sandhu, MD | 909.558.4911 | vksandhu@llu.edu | |
Contact: Micah Yu, MD | 909.558.4911 | micyu@llu.edu |
United States, California | |
Loma Linda University | Recruiting |
Loma Linda, California, United States, 92354 |
Responsible Party: | Loma Linda University |
ClinicalTrials.gov Identifier: | NCT03953261 |
Other Study ID Numbers: |
5190041 |
First Posted: | May 16, 2019 Key Record Dates |
Last Update Posted: | May 13, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |