Crucumin Effects on the Immune System in Osteoarthritis Patients
Evaluation of the Crucumin Effects on the Cellular and Humoral Immune Systems in Osteoarthritis Patients; a Randomised Double Blind Placebo Control Clinical Trial
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedFebruary 19, 2020
February 1, 2020
1.4 years
October 15, 2018
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IL-17
Cytokine level
Baseline
Secondary Outcomes (12)
IL-17
Baseline and three months
TH-1
Baseline and three months
MicroRNA-720
Baseline and three months
CXCL8
Baseline and three months
CXCL1
Baseline and three months
- +7 more secondary outcomes
Study Arms (2)
Patients who will recieve crucumin
EXPERIMENTALpatients 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 COMPARATORPatients who prescribing placebo daily for three months will be evaluated. A sample will be taken before taking the placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis patients who have been diagnosed with a rheumatologist physician based on clinical examinations and laboratory tests
You may not qualify if:
- Affected by any other acute or chronic underlying disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mahdi Atabaki
Mashhad, 9188815435, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mojgan Mohammadi, Ph.D
Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 15, 2018
First Posted
October 23, 2018
Study Start
May 1, 2019
Primary Completion
September 21, 2020
Study Completion
December 30, 2020
Last Updated
February 19, 2020
Record last verified: 2020-02