Crucumin Effects on the Immune System in Osteoarthritis Patients

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715140
• Other study ID #: IR.MUMS.MEDICAL.REC.1397.118
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2020
• Source: Mashhad University of Medical Sciences
• Contact: Mojgan Mohammadi, Ph.D
• Phone: 0098 51 38012762
• Email: mozhganmohammadi69[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Crucumin
Evaluation of the effect of Crucumin in patients with osteoarthritis
• Placebo
Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mahdi Atabaki	Mashhad

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL-17	Cytokine level	Baseline
Secondary	IL-17	Cytokine level	Baseline and three months
Secondary	TH-1	Cell counting	Baseline and three months
Secondary	MicroRNA-720	Gene expression	Baseline and three months
Secondary	CXCL8	Cytokine level	Baseline and three months
Secondary	CXCL1	Cytokine level	Baseline and three months
Secondary	April	Cytokine level	Baseline and three months
Secondary	TH-17	Cell counting	Baseline and three months
Secondary	TReg	Cell counting	Baseline and three months
Secondary	Ly.B	Cell counting	Baseline and three months
Secondary	MicroRNA-155	Gene expression	Baseline and three months
Secondary	MicroRNA-146a	Gene expression	Baseline and three months
Secondary	MicroRNA-16	Gene expression	Baseline and three months