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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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03715140
Enrollment
30
Registered
2018-10-23
Start date
2019-05-01
Completion date
2020-12-30
Last updated
2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Crucumin, Flowcytometry

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.

Interventions

DRUGCrucumin

Evaluation of the effect of Crucumin in patients with osteoarthritis

DRUGPlacebo

Placebo

Sponsors

Mashhad University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IL-17BaselineCytokine level

Secondary

MeasureTime frameDescription
TH-1Baseline and three monthsCell counting
MicroRNA-720Baseline and three monthsGene expression
CXCL8Baseline and three monthsCytokine level
CXCL1Baseline and three monthsCytokine level
AprilBaseline and three monthsCytokine level
IL-17Baseline and three monthsCytokine level
TRegBaseline and three monthsCell counting
Ly.BBaseline and three monthsCell counting
MicroRNA-155Baseline and three monthsGene expression
MicroRNA-146aBaseline and three monthsGene expression
MicroRNA-16Baseline and three monthsGene expression
TH-17Baseline and three monthsCell counting

Countries

Iran

Contacts

Primary ContactMojgan Mohammadi, Ph.D
mozhganmohammadi69@yahoo.co.uk0098 51 38012762
Backup ContactMahdi Atabaki, Student
atabaki80@gmail.com0098 51 38012762

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026