Crucumin Effects on the Immune System in Osteoarthritis Patients

NCT ID: NCT03715140

Last Updated: 2020-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Patients who will recieve crucumin

patients who prescribing crucumin 80 mg daily for three months will be evaluated. A sample will be taken before taking the drug.

Group Type EXPERIMENTAL

Crucumin

Intervention Type DRUG

Evaluation of the effect of Crucumin in patients with osteoarthritis

Patients who will receive placebo

Patients who prescribing placebo daily for three months will be evaluated. A sample will be taken before taking the placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Crucumin

Evaluation of the effect of Crucumin in patients with osteoarthritis

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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nanocrucumin Crucumin placebo

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr. Mojgan Mohammadi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mojgan Mohammadi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

Locations

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Mahdi Atabaki

Mashhad, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mojgan Mohammadi, Ph.D

Role: CONTACT

0098 51 38012762

Mahdi Atabaki, Student

Role: CONTACT

0098 51 38012762

Facility Contacts

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Mahdi Atabaki, Ph.D Candidate

Role: primary

+989303043900

Other Identifiers

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IR.MUMS.MEDICAL.REC.1397.118

Identifier Type: -

Identifier Source: org_study_id

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