The effect of saffaron tablet on the level of inflammatory markers with knee osteoarthritis patients

A double blind clinical trial on the effect of saffaron tablet on changing level of inflammatory markers Interleukin 1 beta(IL1ß) and Tumor necrosis factor alpha(TNFa) in patients with Knee osteoarthritis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016091029777N1

Enrollment

Registered

2017-03-13

Start date

2016-08-22

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

Knee Osteoarthritis. Bilateral primary osteoarthritis of knee

Interventions

Intervention 1: Intervention group: Including daily intake of 100 mg saffron(active constituents crocin) pill for 12 weeks. Intervention 2: Control group:Including daily intake of 100 mg placebo saffr

Treatment - Drugs

Intervention group: Including daily intake of 100 mg saffron(active constituents crocin) pill for 12 weeks

Control group:Including daily intake of 100 mg placebo saffron(false color material and starch) for 12 weeks

Eligibility

Sex/Gender

All

Age

50 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Knee osteoarthritis patients based on American College of Rheumatology(ACR) diagnostic criteria with an intensity of 2 to 3 according to Kellgren and Lawrence(KL) radiography grade, Patients with an average age of 50 to 70 years old; Exclusion criteria: Known hypersensitivity to Saffron, Patients with other rheumatologic diseases, Patients with active malignant disease or infection, Patients with known mental illness, Patients with a history of recent Knee surgery and severe trauma(within 6 months), Patients with hip osteoarthritis, Patients with septic arthritis, Patients with active gastrointestinal bleeding or a history of it, Patients with chronic kidney disease when the estimated Glomerular Filtration Rate(GFR) is less than 30 ml/min/1.73m2, Severe leukopenia, Patients requiring long term use of corticosteroids such as asthma or inflammatory bowel disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum levels of TNF alpha. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: pg/ml.;Serum levels of IL 1 beta. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: pg/ml.	—

Secondary

Measure	Time frame
The intensity of osteoarthritis. Timepoint: Baseline and sixth and twelfth weeks. Method of measurement: WOMAC questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Saeedi

Golestan University of Medical Science

Saeedi.M50@gmail.com+98 17 3242 4377

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026