Effect of Curcumin on Systemic Lupus Erythematosus | NCT03953261

Studies
Effect of Curcumin on Systemic Lupus Erythematosus

NCT03953261

Sponsor

Loma Linda University

Status

Terminated

Last Update Posted

Aug 5, 2022Actual

Enrollment

23Actual

Phase

Phase 2

Conditions

Systemic Lupus Erythematosus

Interventions

Curcumin supplement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID and lack of support staff 2. lack of support staff to conduct the study

Expanded Access Info

Not provided

Start Date

Sep 1, 2019Actual

Primary Completion Date

Apr 13, 2022Actual

Completion Date

Apr 13, 2022Actual

First Submitted Date

May 14, 2019

First Submission Date that Met QC Criteria

May 14, 2019

First Posted Date

May 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2022

Last Update Posted Date

Aug 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Curcumin	Experimental		Drug: Curcumin supplement
Placebo	Placebo Comparator		Drug: Curcumin supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Curcumin supplement	Drug	Intervention is 2 grams of curcumin supplement per day	Curcumin Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in SLEDAI	Number of participants with change in SLEDAI by 2 points by Day 90	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University		Loma Linda	California	92354	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 13, 2023			May 4, 2023	8

Condition Browse Module

MeSH Terms

ID	Term
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided