Crucumin Effects on the Immune System in Osteoarthritis P... | NCT03715140

Studies
Crucumin Effects on the Immune System in Osteoarthritis Patients

NCT03715140

Sponsor

Mashhad University of Medical Sciences

Status

Unknown status

Last Update Posted

Feb 19, 2020Actual

Enrollment

30Estimated

Phase

Phase 3

Conditions

Osteoarthritis

Interventions

Crucumin
Placebo

Countries

Iran

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Sep 21, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Oct 15, 2018

First Submission Date that Met QC Criteria

Oct 22, 2018

First Posted Date

Oct 23, 2018Actual

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

Feb 18, 2020

Last Update Posted Date

Feb 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Mojgan Mohammadi, Associate Professor, Mashhad University of Medical SciencesPrincipal Investigator

Lead Sponsor

Mashhad University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

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

In this study, the effects of crucumin on cellular and humoral immune system in patients with osteoarthritis will be investigated. Concentration of CXCL8, April, CX3CL1 and IL-17 will be evaluated with ELISA. TH-1, TH-17, TReg and Ly.B cells count will be measured by Flowcytometry. MicroRNA-720, MicroRNA-155, MicroRNA-16 and MicroRNA-146a gene expression will be measured with Real Time PCR technique.

Detailed Description

The purpose of this study was to evaluate the effect of the active ingredient of crucumin on the reduction of symptoms of osteoarthritis. Of the 30 patients participating in this study, a blood sample will be taken at the beginning of the study, and then after three months of taking the crucumin. To evaluate the response to treatment, after each person sampling, we will analyze cell count for Th-1, Th-17, TReg and Ly.B by flowcytomtry method. Also we will measure cytokines level of IL-17, CXCL8, CX3CL1 and April by ELISA method. Finally we evaluate the gene expression of MicroRNA-720, MicroRNA-155, MicroRNA-146a and MicroRNA-16 by Real Time PCR technique.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients who will recieve crucumin	Experimental	patients who prescribing crucumin 80 mg daily for three months will be evaluated. A sample will be taken before taking the drug.	Drug: Crucumin
Patients who will receive placebo	Placebo Comparator	Patients who prescribing placebo daily for three months will be evaluated. A sample will be taken before taking the placebo.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Crucumin	Drug	Evaluation of the effect of Crucumin in patients with osteoarthritis	Patients who will recieve crucumin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IL-17	Cytokine level	Baseline

Secondary Outcomes

Measure	Description	Time Frame
IL-17	Cytokine level	Baseline and three months
TH-1	Cell counting	Baseline and three months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Osteoarthritis patients who have been diagnosed with a rheumatologist physician based on clinical examinations and laboratory tests

Exclusion Criteria:

Affected by any other acute or chronic underlying disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mojgan Mohammadi, Ph.D	Contact	0098 51 38012762		mozhganmohammadi69@yahoo.co.uk
Mahdi Atabaki, Student	Contact	0098 51 38012762		atabaki80@gmail.com

Overall Officials

Name	Affiliation	Role
Mojgan Mohammadi, Ph.D	Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mahdi Atabaki	Recruiting	Mashhad		9188815435	Iran

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Preferring the data to remain confidential

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided