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A single-center, randomized, single-blind, controlled clinical trial of combined celecoxib with ketotifen fumarate to inhibit the recurrence of stiffness after release surgery for post-traumatic elbow stiffness

A single-center, randomized, single-blind, controlled clinical trial of combined celecoxib with ketotifen fumarate to inhibit the recurrence of stiffness after release surgery for post-traumatic elbow stiffness

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078332
Enrollment
Unknown
Registered
2023-12-05
Start date
2023-12-15
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Post-traumatic elbow stiffness

Interventions

Control group (Celecoxib):Celecoxib 200mg/ time, orally, twice daily (bid), from the first day after surgery, for 8 weeks.
Experimental group (ketotifen fumarate + Celecoxib):celecoxib 200mg/ time, oral, twice daily (bid) plus Ketotifen fumarate 1.38mg (equivalent to ketotifen 1mg) per dose, orally, twice daily (bid), fro

Sponsors

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are fully aware of the study and voluntarily sign the informed consent 2. Aged 18-65. 3. Patients with the diagnosis of post-traumatic elbow stiffness and indications for elbow joint release surgery 4. Patients who had not taken celecoxib or ketotifen fumarate within 6 months before the enrollment 5. Patients who can complete the treatment and follow-up plan.

Exclusion criteria

Exclusion criteria: 1. Patient has other diseases that may cause joint stiffness, such as osteoarthritis and rheumatoid arthritis. 2. The affected elbow had undergone a previous surgery. 3. Pregnant women or lactating women, and those who plan to have children in nearly six months. 4. Patients with diabetes mellitus, osteoporosis, severe malnutrition, moderate to severe anemia, and severe liver and kidney insufficiency. 5. There are circumstances in which celecoxib is not suggested to be taken: hemorrhagic purpura, a history of allergic reactions such as anaphylactic shock, rash, urticaria, angioedema, bronchospasm, severe rhinitis; asthma patients; patients with active gastrointestinal ulcers/bleeding; patients with severe heart failure; persons with known allergies to sulfanilamide; patients who have asthma, hives, or allergic reactions after taking aspirin or other NSAIDs. 6. Ketotemen fumarate is not suggested to be taken, such as when taking hormone drugs, diabetes mellitus using hypoglycemic drugs, taking sedative and sleeping drugs, taking atropine anti-allergic drugs, antihistamines, etc. If the patient is engaged in driving, driving a boat, flying an airplane, or doing sophisticated work, it is not recommended to use ketotifen fumarate tablets. 7.Patients with severe adverse drug reactions and intolerance to celecoxib or ketotifen fumarate. 8.Patients who have a failed release operation, or have postoperative complications such as postoperative infection and wound unhealing. 9.Patients requiring other anti-inflammatory drugs, antihistamines, and antiallergic drugs after operation.

Design outcomes

Primary

MeasureTime frame
Elbow flexion and extension range of motion;

Secondary

MeasureTime frame
Mayo Elbow Function score;Peripheral blood neuropeptide;Mast cell markers (tryptase, histamine, N-methylhistamine);Fibrosis index (collagen type I and procollagen type III PCIII);Growth factor index (TGF-ß1, CTGF, bFGF, PDGF);

Countries

China

Contacts

Public ContactLi Fengfeng

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

fengmale@163.com+86 189 3017 3095

Outcome results

None listed

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