Crucumin Effects on the Immune System in Osteoarthritis Patients

Mashhad University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Crucumin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03715140

IR.MUMS.MEDICAL.REC.1397.118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Patients who will recieve crucumin

Experimental group

Description:

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

Treatment:

Drug: Crucumin

Patients who will receive placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo