MedTrace Logo

Evaluation Effect of Crocina on The Cellular Immune Responses in Osteoarthritis Patients

NCT03375814 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-12-18

No results posted yet for this study

Summary

The effect of Crocina on the production of IL-4, IL-1 bet, IL-17, IL-10 and TGF-beta: The effect of crocina on gene expression of transcription factors T-bet, GATA-3. FOXP3, ROR-γt,; The effect of helper T cells type one and two, regulatory T cells and T helper type 17 cells; the effect of crocina on the reduction of pain and joint inflammation. Design: Randomized, Double-blind and Placebo controlled; Study population: Patients with Osteoarthritis; Volume: 40 persons; Method: Osteoarthritis patients will be divided into two groups according to age and sex; Crocina tablets will be prescribed to the first group a tablet 15 mg daily along with conventional Medicines; Placebo tablets will be prescribed to the second group along with the conventional medicines; Blood sampling of patients will be done before drug administering and four months after treatment. Major Inclusion Criteria: Osteoarthritis patients with age 40-75 years; The severity of joint damage between grade 2 and 3; Patients without history of injury; Patients with body mass index less than 30. Major Exclusion Criteria: Osteoarthritis patients with age 40-75 years; The severity of joint damage in grade one and four; Patients with history of injury and body mass index 30 or more. Intervention: Treatment with prescription of drug at dose of 15 mg daily crocin in the study group and placebo in the control group. Time: 4 months; Main outcome Measures: Osteoarthritis, Pain, Inflammation, Crocina, IL-4, IL-1 beta, IL-17, IL-10, TGF- beta, Cell surface protein CD127, The expression of T-bet, GATA-3, FOXP3, ROR-γt and the number of Th1, Th2, T-regulatory and Th17.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Crocin

This group (osteoarthritic patients) can receive crocin with conventional therapy

DRUG

Placebo Oral Tablet

The group that takes Placebo Oral Tablet. They received the conventional treatment and Placebo Pills..

Sponsors & Collaborators

  • Mashhad University of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-20
Primary Completion
2018-03-02
Completion
2018-07-30

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03375814 on ClinicalTrials.gov