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Trial record 1 of 3336 for:    "Osteoarthritis"
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Crucumin Effects on the Immune System in Osteoarthritis Patients

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ClinicalTrials.gov Identifier: NCT03715140
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Mojgan Mohammadi, 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Crucumin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 21, 2019
Estimated Primary Completion Date : December 21, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: 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 Name: Crucumin placebo




Primary Outcome Measures :
  1. IL-17 [ Time Frame: Baseline ]
    Cytokine level


Secondary Outcome Measures :
  1. IL-17 [ Time Frame: Baseline and three months ]
    Cytokine level

  2. TH-1 [ Time Frame: Baseline and three months ]
    Cell counting

  3. MicroRNA-720 [ Time Frame: Baseline and three months ]
    Gene expression

  4. CXCL8 [ Time Frame: Baseline and three months ]
    Cytokine level

  5. CXCL1 [ Time Frame: Baseline and three months ]
    Cytokine level

  6. April [ Time Frame: Baseline and three months ]
    Cytokine level

  7. TH-17 [ Time Frame: Baseline and three months ]
    Cell counting

  8. TReg [ Time Frame: Baseline and three months ]
    Cell counting

  9. Ly.B [ Time Frame: Baseline and three months ]
    Cell counting

  10. MicroRNA-155 [ Time Frame: Baseline and three months ]
    Gene expression

  11. MicroRNA-146a [ Time Frame: Baseline and three months ]
    Gene expression

  12. MicroRNA-16 [ Time Frame: Baseline and three months ]
    Gene expression



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715140


Contacts
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Contact: Mojgan Mohammadi, Ph.D 0098 51 38012762 mozhganmohammadi69@yahoo.co.uk
Contact: Mahdi Atabaki, Student 0098 51 38012762 atabaki80@gmail.com

Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
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Principal Investigator: Mojgan Mohammadi, Ph.D Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

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Responsible Party: Dr. Mojgan Mohammadi, Associate Professor, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03715140     History of Changes
Other Study ID Numbers: IR.MUMS.MEDICAL.REC.1397.118
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Preferring the data to remain confidential

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Mojgan Mohammadi, Mashhad University of Medical Sciences:
Osteoarthritis, Crucumin, Flowcytometry

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases