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Evaluation of therapeutic effects of Crocina in knee osteoarthritis

Evaluation of therapeutic and immunologic effects of Crocina in knee osteoarthritis patients: A randomized double-blind placebo-controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190419043318N1
Enrollment
60
Registered
2019-07-02
Start date
2019-07-23
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

osteoarthritis. Primary osteoarthritis of other joints

Interventions

Intervention 1: Intervention group: Acetaminophen tablet 4 times a day plus NSAIDs with one glass of water (one of the following NSAIDs will be considered: 1200mg Ibuprofen, 75mg Indomethacin, 500mg

Sponsors

Bojnourd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) aged over 40 years 2) Primary osteoarthritis 3) Pain in more than half the days of the previous month during one of the following activities: walking, climbing and stairs, standing up or sleeping on the bed or mattress during the night 4) Radiographic evidence of tibiafemoral or patellofemoral osteoarthritis 5) A score of 40 from the WOMAC scale as a base 6) No intra-articular injection of hyaluronic acid / glucocorticoid over the last six months 7) The lack of a positive pregnancy test or pregnancy program during the study

Exclusion criteria

Exclusion criteria: 1) intolerance to the drug 2) Do not take medicine properly 3) Serious medical conditions that the patient can not regularly attend periodic visits include severe cardiovascular disease such as angina or heart attack, severe hypertension, recent stroke, insulin dependent diabetes, psychiatric disorders, kidney disease, liver disease, active concen , And anemia 4) history of liver disease 5) Inability to walk without a cane 6) A history of autoimmune diseases such as rheumatoid arthritis 7) Secondary osteoarthritis, for example, following a trauma

Design outcomes

Primary

MeasureTime frame
Joint range of movement. Timepoint: Weeks 1,2,3,7,16. Method of measurement: Clinical examination.;Pain. Timepoint: Weeks 1,2,3,7,16. Method of measurement: VAS, KOOS and WOMAC questionnaire.

Secondary

MeasureTime frame
Change in serum levels of inflammatory mediators (IL-1? INF-?). Timepoint: Weeks of 1 and 16. Method of measurement: ELISA Kits.;Change in serum levels of inflammatory and anti-inflammatory mediators(IL-10). Timepoint: Weeks of 1 and 16. Method of measurement: ELISA Kits.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAdeleh Sahebnasagh

Bojnourd University of Medical Sciences

adelehsn67@yahoo.com+98 58 3226 3604

Outcome results

None listed

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