search
Back to results

Crucumin Effects on the Immune System in Osteoarthritis Patients

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Crucumin
Placebo
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Crucumin, Flowcytometry

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mahdi AtabakiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Patients who will recieve crucumin

Patients who will receive placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

IL-17
Cytokine level

Secondary Outcome Measures

IL-17
Cytokine level
TH-1
Cell counting
MicroRNA-720
Gene expression
CXCL8
Cytokine level
CXCL1
Cytokine level
April
Cytokine level
TH-17
Cell counting
TReg
Cell counting
Ly.B
Cell counting
MicroRNA-155
Gene expression
MicroRNA-146a
Gene expression
MicroRNA-16
Gene expression

Full Information

First Posted
October 15, 2018
Last Updated
February 18, 2020
Sponsor
Mashhad University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03715140
Brief Title
Crucumin Effects on the Immune System in Osteoarthritis Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
September 21, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Crucumin, Flowcytometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients who will recieve crucumin
Arm Type
Experimental
Arm Description
patients who prescribing crucumin 80 mg daily for three months will be evaluated. A sample will be taken before taking the drug.
Arm Title
Patients who will receive placebo
Arm Type
Placebo Comparator
Arm Description
Patients who prescribing placebo daily for three months will be evaluated. A sample will be taken before taking the placebo.
Intervention Type
Drug
Intervention Name(s)
Crucumin
Other Intervention Name(s)
nanocrucumin
Intervention Description
Evaluation of the effect of Crucumin in patients with osteoarthritis
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Crucumin placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
IL-17
Description
Cytokine level
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
IL-17
Description
Cytokine level
Time Frame
Baseline and three months
Title
TH-1
Description
Cell counting
Time Frame
Baseline and three months
Title
MicroRNA-720
Description
Gene expression
Time Frame
Baseline and three months
Title
CXCL8
Description
Cytokine level
Time Frame
Baseline and three months
Title
CXCL1
Description
Cytokine level
Time Frame
Baseline and three months
Title
April
Description
Cytokine level
Time Frame
Baseline and three months
Title
TH-17
Description
Cell counting
Time Frame
Baseline and three months
Title
TReg
Description
Cell counting
Time Frame
Baseline and three months
Title
Ly.B
Description
Cell counting
Time Frame
Baseline and three months
Title
MicroRNA-155
Description
Gene expression
Time Frame
Baseline and three months
Title
MicroRNA-146a
Description
Gene expression
Time Frame
Baseline and three months
Title
MicroRNA-16
Description
Gene expression
Time Frame
Baseline and three months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mojgan Mohammadi, Ph.D
Phone
0098 51 38012762
Email
mozhganmohammadi69@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mahdi Atabaki, Student
Phone
0098 51 38012762
Email
atabaki80@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mojgan Mohammadi, Ph.D
Organizational Affiliation
Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahdi Atabaki
City
Mashhad
ZIP/Postal Code
9188815435
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahdi Atabaki, Ph.D Candidate
Phone
+989303043900
Email
atabaki80@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Preferring the data to remain confidential

Learn more about this trial

Crucumin Effects on the Immune System in Osteoarthritis Patients

We'll reach out to this number within 24 hrs