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

NCT03375814 | Unknown Phase 3 DMC

• 1 other identifier: 931577
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Radiographic report from knee

  Patients suffering from osteoarthritis are classified in grades 1 to 4 and grades 2 and 3 will be enter to study.

  15 minute

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Crocin

Placebo group

PLACEBO COMPARATOR

The group that takes the Placebo.

Drug: Placebo Oral Tablet

Interventions

Crocin DRUG

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

Also known as: Test group

Experimental group

Placebo Oral Tablet DRUG

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

Also known as: Control group

Placebo group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Jaleh Shariati sarabi

Mashhad, Razavi Khorasan Province, Iran

Location

Related Publications (1)

• 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.

  PMID: 35822682 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Inflammation

Interventions

crocin; Control Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Tafaghodi Mohsen

Model Details: Osteoarthritis patients who have age between 40 to 75 years old will be selected; Based on radiographic images of patients the severity of joints damage will get detailed and they will be placed in between grade 2 and grade 3 in terms of gradation; these patients will be not located underwent surgery; Patients will complete WOMAC and KOOS questionnaires to obtain some information such as following items; They will be no history of injury; they will not have diabetic disorders, rheumatism and kidney disease, osteonecrosis, gout; they will not have a long history anti-inflammatory drugs consumption; They will not have individuals with insufferable jobs carrying heavy loads; Patients will not have the Body Mass Index (BMI) of 30 or more

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: December 18, 2017
• Study Start: July 20, 2016
• Primary Completion: March 2, 2018
• Study Completion: July 30, 2018
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

IR (1)