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

NCT ID: NCT03375814

Last Updated: 2017-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-20
• Study Completion Date: 2018-07-30

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

Conditions

Osteoarthritis, Knee

Keywords

Crocin, osteoarthritis, Inflammation, IL-17,T-helper,T-reg

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

The group that takes the main drug. They received the conventional treatment group and crocin.

Group Type: EXPERIMENTAL

Crocin

Intervention Type: DRUG

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

Placebo group

The group that takes the Placebo.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

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

Interventions

Crocin

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

Intervention Type: DRUG

Placebo Oral Tablet

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

Intervention Type: DRUG

Other Intervention Names

Test group; Control group

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Shariati Jaleh

Dr. Tafaghodi Mohsen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jaleh Shariati sarabi

Mashhad, Razavi Khorasan Province, Iran

Countries

Iran

References

Mohebbi M, Atabaki M, Tavakkol-Afshari J, Shariati-Sarabi Z, Poursamimi J, Mohajeri SA, Mohammadi M. Significant Effect of Crocin on the Gene Expression of MicroRNA-21 and MicroRNA-155 in Patients with Osteoarthritis. Iran J Allergy Asthma Immunol. 2022 Jun 18;21(3):322-331. doi: 10.18502/ijaai.v21i3.9805.

Reference Type: DERIVED

PMID: 35822682 (View on PubMed)

Other Identifiers

931577

Identifier Type: -

Identifier Source: org_study_id