Crucumin Effects on the Immune System in Osteoarthritis Patients

Study Overview
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Crucumin
* Drug: Placebo


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients who will recieve crucumin<br>patients who prescribing crucumin 80 mg daily for three months will be evaluated. A sample will be taken before taking the drug. | Drug: Crucumin<br>* Evaluation of the effect of Crucumin in patients with osteoarthritis<br>* Other names: nanocrucumin;|
| Placebo Comparator: Patients who will receive placebo<br>Patients who prescribing placebo daily for three months will be evaluated. A sample will be taken before taking the placebo. | Drug: Placebo<br>* Placebo<br>* Other names: Crucumin placebo;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Crucumin, Flowcytometry