Crucumin Effects on the Immune System in Osteoarthritis Patients

Phase 3

• Conditions: Osteoarthritis
• Interventions: Drug: Crucumin; Drug: Placebo

• Registration Number: NCT03715140
• Lead Sponsor: Mashhad University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-23
• Study Start: 2019-05-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19
• Primary Completion: 2020-09-21
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients who will recieve crucumin	Crucumin	patients who prescribing crucumin 80 mg daily for three months will be evaluated. A sample will be taken before taking the drug.
Patients who will receive placebo	Placebo	Patients who prescribing placebo daily for three months will be evaluated. A sample will be taken before taking the placebo.

Primary Outcome Measures

Name	Time	Method
IL-17	Baseline	Cytokine level

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mahdi Atabaki; 🇮🇷 Mashhad, Iran, Islamic Republic of