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Evaluation of ketoconazole in treatment of knee osteoarthritis: a single-center single-arm clinical trial

Evaluation of ketoconazole in treatment of knee osteoarthritis: a single-center single-arm clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075192
Enrollment
Unknown
Registered
2023-08-29
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Knee osteoarthritis

Interventions

Experimental group:2% ketoconazole cream, 1FTU/joint/day applied to the affected joint

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age > 40 years old and < 60 years old, and clinically diagnosed as knee osteoarthritis according to ACR criteria. 2. The joint pain lasts for more than 6 months and most of the time in the last month, the patients with WOMAC pain score = 8 after physical therapy and first-line NSAIDs treatment; 3. X-rays showed Kellgren and Lawrence grade 2 or 3 osteoarthritis. 4. Those who are not willing to receive intraarticular steroid therapy or opioid medication for pain control. 5. Those who are willing to cooperate with the investigation and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have had surgery on the joint or plan to have surgery on knee. 2. Suffering from other diseases such as: systemic or inflammatory joint disease (rheumatoid arthritis), history of crystalline or neuropathic joint disease, other muscle, joint or nervous system diseases that affect the function of the lower limbs. 3. History of allergy to ketoconazole. 4. There is immunosuppression or acute infection. 5. Have or have had malignant tumors. 6. Have any other medical conditions that cannot participate in the study, including contraindications to MRI, such as cardiac pacemakers. 7. Pregnancy. 8. Body mass index (BMI) > 40 kg/m2. 9. Inability to understand written and spoken Chinese. 10. Have any history of mental and psychological diseases.

Design outcomes

Primary

MeasureTime frame
WOMAC pain score;

Secondary

MeasureTime frame
WOMAC total score;WOMAC joint stiffness score;WOMAC Physical Function Score;MOAKS hoffa's synovitis score;MOAKS synovitis-effusion score;MOAKS Bone marrow lesions score;

Countries

China

Contacts

Public ContactJunjie Gao, Changqing Zhang

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

colingjj@163.com+86 150 6717 5608

Outcome results

None listed

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