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

• Status: Unknown status
• Trial end date: 2018-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mashhad University of Medical Sciences

Criteria

Inclusion Criteria:

Osteoarthritis patients must have

• Aged 40 to 75.

• The severity of joint damage between grade 2 and grade 3 based on radiographic images.

• No history of joint surgery.

• No history of injury.

• No diabetic disorders.

• No rheumatism.

• No kidney disease.

• No osteonecrosis and gout.

• No long history of anti-inflammatory drugs consumption.

• No insufferable jobs;

• The Body Mass Index (BMI) of 30 or less.

Exclusion Criteria:

Osteoarthritis patients should not have:

• Aged less than 40 and more than 75

• With the severity of joint damage of the in grade 1 and grade 4 based on radiographic images.

• With history of joint surgery.

• With history of injury

• With diabetic disorders, rheumatism, kidney disease, osteonecrosis and gout.

• With long history of anti-inflammatory drugs consumption.

• Having insufferable jobs.

• With a BMI of 30 or more.