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A randomized controlled clinical trial of intra-articular injection of chlorphenamine maleate in the treatment of early and middle phase of knee osteoarthritis

A randomized controlled clinical trial of intra-articular injection of chlorphenamine maleate in the treatment of early and middle phase of knee osteoarthritis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055192
Enrollment
Unknown
Registered
2022-01-02
Start date
2022-01-03
Completion date
Unknown
Last updated
2023-03-12

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

Conditions

Osteoarthritis

Interventions

Control Group:Sodium hyaluronate is injected into the joint cavity once a week for 8 weeks
Experimental Group:Chlorphenamine maleate combined with sodium hyaluronate are injected into the articular cavity once a week for 8 weeks

Sponsors

Department of Cell Biology, School of Basic Medicine, Southern Medical University, Guangdong Key Laboratory of Bone and Joint Degenerative Diseases
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged = 20mm in the past week; 5. The patient agrees and can tolerate X-ray plain film scanning; 6. The patient agrees to undergo MRI testing; 7. The patients voluntarily participate in the research and can provide written informed consent; 8. Patients may receive telephone interviews or visit the hospital for follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant patients or positive pregnancy test, nursing status; 2. Patients with rheumatoid arthritis and other autoimmune diseases or serious diseases, such as: psoriatic arthritis, lupus, active cancer, severe cardiovascular and kidney diseases, etc.; 3. Those with bleeding tendency or coagulation dysfunction; 4. Skin disease or skin infection around the site to be injected, and knee joint infection, surgery and radiotherapy within the past three months; 5. Those who have used intra-articular injection, intramuscular injection and oral glucocorticoid or sodium hyaluronate or all histamine H1 receptor antagonists within the past 3 months; 6. Have a history of allergic reaction to any ingredient in the study drug; 7. Contraindications of MRI such as pacemaker, artificial metal valve, aneurysm clipping, arterial dissection, claustrophobia, etc.; 8. Those who are participating in and affecting other research experiments that affect the results of this research; 9. The researcher believes that it is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Western Ontario McMasters Osteoarthritis Index (WOMAC);

Secondary

MeasureTime frame
Clinical symptom score;Loss of knee cartilage volume;Change in bone marrow lesions;Change in joint effusion;X-Ray examination;Changes of inflammatory factors in blood;

Countries

China

Contacts

Public ContactBai Xiaochun

Department of Cell Biology, School of Basic Medicine, Southern Medical University, Guangdong Key Laboratory of Bone and Joint Degenerative Diseases

baixc15@smu.edu.cn+86 13632102925

Outcome results

None listed

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