A randomized, double-blind, placebo-controlled study of the tricolor ointment for the treatment of osteoarthritic synovitis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200006804

Enrollment

Unknown

Registered

2022-11-21

Start date

2022-12-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Synovitis

Interventions

Control group:Celebrex and Placebo of the Tricolor ointment

Treatment group:Celebrex and Tricolor ointment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Clinical criteria: ? pain in the knee ?Crepitus on active movements ? Morning stiffness=30 min; ?Age=50 years ? swelling of knee joint; ? knee joint distension discomfort or pain; ? When the knee joint is straight or completely flexed, the feeling of distension discomfort or pain is significantly aggravated; ?palpable warmth ? Positive patellar tap test, or excessive effusion in knee joint detected by B-ultrasound or MRI; Patients with ??? and any two other conditions can be diagnosed as knee osteoarthritis synovitis. Inclusion criteria: ?meeting the above diagnostic criteria;?Age 50-70 years;?Kellgren-Lawrence classification belongs to grade 1, 2, 3; (4) The VAS pain score was 4-7; ? Volunteer to participate in this trial, and sign the informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria ? women who are preparing to become pregnant or pregnant or breastfeeding; ? Allergic constitution or allergic to known components of the drug used in this test; ? Patients with knee osteoarthritis without swelling, rheumatoid arthritis, rheumatoid arthritis, infectious arthritis, gouty synovitis, synovial tuberculosis, synovioma, hemophilia arthritis, bone tumor, pigmented villonodular synovitis, osteomalacia, multiple myeloma, diabetes mellitus and other serious primary diseases; (4) Hematoma or hyperthyroidism or liver and kidney insufficiency in the knee joint cavity; ? patients with a history of drug abuse, alcoholism, mental illness or Alzheimer's disease; ? Patients who had been treated for synovitis of knee joint within 3 months before the test; ? have participated in other drug clinical trials within 3 months.

Design outcomes

Primary

Measure	Time frame
visual analogue scale;WOMAC OSTEOARTHRITIS INDEX;	—

Secondary

Measure	Time frame
Knee Circumference;The range of motion of the knee joint;SF-36 score;	—

Countries

China

Contacts

Public ContactWEI HOU

WEIHOU313@163.COM13816328482

Outcome results

None listed

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