Crucumin Effects on the Immune System in Osteoarthritis Patients

February 18, 2020 updated by: Dr. Mojgan Mohammadi, Mashhad University of Medical Sciences

Evaluation of the Crucumin Effects on the Cellular and Humoral Immune Systems in Osteoarthritis Patients; a Randomised Double Blind Placebo Control Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Crucumin
Evaluation of the effect of Crucumin in patients with osteoarthritis
Other Names:
  • nanocrucumin
PLACEBO_COMPARATOR: 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.
Drug: Placebo
Placebo
Other Names:
  • Crucumin placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-17
Time Frame: Baseline
Cytokine level
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-17
Time Frame: Baseline and three months
Cytokine level
Baseline and three months
TH-1
Time Frame: Baseline and three months
Cell counting
Baseline and three months
MicroRNA-720
Time Frame: Baseline and three months
Gene expression
Baseline and three months
CXCL8
Time Frame: Baseline and three months
Cytokine level
Baseline and three months
CXCL1
Time Frame: Baseline and three months
Cytokine level
Baseline and three months
April
Time Frame: Baseline and three months
Cytokine level
Baseline and three months
TH-17
Time Frame: Baseline and three months
Cell counting
Baseline and three months
TReg
Time Frame: Baseline and three months
Cell counting
Baseline and three months
Ly.B
Time Frame: Baseline and three months
Cell counting
Baseline and three months
MicroRNA-155
Time Frame: Baseline and three months
Gene expression
Baseline and three months
MicroRNA-146a
Time Frame: Baseline and three months
Gene expression
Baseline and three months
MicroRNA-16
Time Frame: Baseline and three months
Gene expression
Baseline and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Principal Investigator: Mojgan Mohammadi, Ph.D, Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ANTICIPATED)

September 21, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (ACTUAL)

October 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.MUMS.MEDICAL.REC.1397.118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Preferring the data to remain confidential

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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