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Evaluation of Crocina on The Cellular Immune Responses in Osteoarthritis Patients

Evaluation of Crocina on The Cellular Immune Responses in Osteoarthritis Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015021910507N2
Enrollment
40
Registered
2016-07-11
Start date
2016-07-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis. Polyarthrosis, unspecified Generalized osteoarthritis NOS

Interventions

Intervention 1: Intervention Group: Prescription of Crocina drug daily at dose of 15 milligram for 4 months. Intervention 2: Control Group: Prescription of placebo daily at dose of 15 milligram for 4
Treatment - Drugs
Placebo
Intervention Group: Prescription of Crocina drug daily at dose of 15 milligram for 4 months.
Control Group: Prescription of placebo daily at dose of 15 milligram for 4 months.

Sponsors

Research Chancellor, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Osteoarthritis patients aged 40 to 75; Patients with the severity of joint damage between grade 2 and grade 3 based on radiographic images; Patients with no history of joint surgery; Patients with no history of injury, no diabetic disorders, no rheumatism, no kidney disease, no osteonecrosis and gout; Patients with no long history of anti-inflammatory drugs consumption; Patients having no insufferable jobs; Patients with the Body Mass Index (BMI) of 30 or less. Exclusion Criteria: Osteoarthritis patients aged less than 40 and more than 75; Patients with the severity of joint damage of the in grade 1 and grade 4 based on radiographic images; Patients with history of joint surgery; Patients with history of injury, diabetic disorders, rheumatism, kidney disease, osteonecrosis and gout; Patients with long history of anti-inflammatory drugs consumption; Patients having insufferable jobs; Patients with a BMI of 30 or more.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Inflammation. Timepoint: Before The Intervention and 4 months after. Method of measurement: Visual.;Pain. Timepoint: Before The Intervention and 4 months after. Method of measurement: Visual.;Osteoarthritis. Timepoint: Before The Intervention and 4 months after. Method of measurement: Visualization and gradation 1 to 4.;Crocin. Timepoint: Four months after the intervention. Method of measurement: International units per millilitre.;Interleukin-4. Timepoint: Before the intervention and 4 months after. Method of measurement: Picograms per millilitre using ELISA Assay.;Interleukin-10. Timepoint: Before the intervention and 4 months after. Method of measurement: Picograms per millilitre using ELISA Assay.;Interleukin-1ß. Timepoint: Before the intervention and 4 months after. Method of measurement: Picograms per millilitre using ELISA Assay.;TGF-ß. Timepoint: Before the intervention and 4 months after. Method of measurement: Picograms per millilitre using ELISA Assay.;Interleukin-17. Timepoint: Before the intervention and 4 months after. Method of measurement: Picograms per millilitre using ELISA Assay.;CD127. Timepoint: Before the intervention and 4 months after. Method of measurement: Frequency of desired cells using Fow Cytometry Technique.;T-bet transcription factor. Timepoint: Before the intervention and 4 months after. Method of measurement: The copy number of desired gene using RT-PCR Assay.;FOXP3 transcription factor. Timepoint: Before the intervention and 4 months after. Method of measurement: The copy number of desired gene using RT-PCR Assay.;GATA3 transcription factor. Timepoint: Before the intervention and 4 months after. Method of measurement: The copy number of desired gene using RT-PCR Assay.;ROR-?t transcription factor. Timepoint: Before the intervention and 4 months after. Method of measurement: The copy number of desired gene using RT-PCR Assay.;Regulatory T Cells. Timepoint: Before the intervention and 4 months after. Method of measurement: Frequency

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Sanchooli

Mashhad University of Medical Sciences

Sanchoolij921@mums.ac.ir; Sanchoolijavad@gmail.com+98 51 3801 2762

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026