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

Phase 3

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Placebo Oral Tablet; Drug: Crocin

• Registration Number: NCT03375814
• Lead Sponsor: Mashhad University of Medical Sciences

Brief 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.

Detailed Description

The effect of crocina on the production of IL-4, IL-1β, IL-17, IL-10 and TGF-β by ELISA assay;The effect of crocina on gene expression of transcription factors T-bet, GATA3, FOXP3, ROR-γt by Real-Time PCR; The effect of crocina on number of helper T cells type one and two, regulatory T cells and T helper type 17 cells by Flow Cytometry analysis; The effect of crocina on the reduction of pain and joint inflammation by WOMAC osteoarthritis index, vas score pain and CRP, ESR diagnostic tests . 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 the conventional medicines. 30 pills of crocina or placebo in cans quite similar and be encoded with Excel Software will be given to the patients completely random; The distributor and the patient will have no knowledge of the contents of the cans; After the end of each month, the patients will receive similar to their previous code. Blood sampling of patients will be done before drug administering and four months after the treatment. Major Inclusion Criteria: Osteoarthritis patients with age 40 to 75 years; The severity of joint damage between grade 2 and 3; Patients without history of injury; Patients with the Body Mass Index (BMI) less than 30. Major Exclusion Criteria: Osteoarthritis patients with age less than 40 and more than 75; The severity of joint damage in the 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, Crocin, IL-4, IL-1 beta, IL-17, IL-10, TGF-beta, Cell surface CD127, The expression of T-bet; GATA3; FOXP3; RORgt and the number of Th1, Th2, T-regulatory and Th17

Study Timeline

• Study Start: 2016-07-20
• Study First Submitted: 2017-10-12
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-12
• Last Update Submitted: 2017-12-12
• Study First Posted: 2017-12-18
• Last Update Posted: 2017-12-18
• Primary Completion: 2018-03-02
• Study Completion: 2018-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo Oral Tablet	The group that takes the Placebo.
Experimental group	Crocin	The group that takes the main drug. They received the conventional treatment group and crocin.

Primary Outcome Measures

Name	Time	Method
Radiographic report from knee	15 minute	Patients suffering from osteoarthritis are classified in grades 1 to 4 and grades 2 and 3 will be enter to study.

Trial Locations

Locations (1)

Jaleh Shariati sarabi; 🇮🇷 Mashhad, Razavi Khorasan, Iran, Islamic Republic of