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Clinical Efficacy Study of Zhuanggu Jianxi Decoction in Treating Cartilage Degeneration and Abnormal Subchondral Bone Remodeling in Patients with Knee Osteoarthritis

Clinical Efficacy Study of Zhuanggu Jianxi Decoction in Treating Cartilage Degeneration and Abnormal Subchondral Bone Remodeling in Patients with Knee Osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000478
Enrollment
Unknown
Registered
2026-03-09
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

knee osteoarthritis

Interventions

control group:Diclofenac Capsules

Sponsors

The Third People's Hospital affiliated to Fujian University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria of KOA; (2) Meets the diagnostic and syndrome differentiation criteria of traditional Chinese medicine; (3) Radiological X-ray K-L classification: grades I-III, accompanied by narrowed joint space, cystic changes or sclerosis of subchondral bone; (4) Age 50-75 years old, gender not limited; (5) Has not taken or injected drugs affecting bone metabolism in the past 3 months; (6) The patient is willing to participate in and cooperate with this study, and signs the informed consent form for clinical research.

Exclusion criteria

Exclusion criteria: (1) Patients with secondary KOA due to knee joint trauma; (2) Patients with combined dysfunction of important organs such as heart, liver and kidney; (3) Patients with malignant tumors or local benign tumors in the knee joint; (4) Patients with rheumatoid arthritis, ankylosing spondylitis, gout, metabolic bone diseases and other serious diseases; (5) Patients with history of knee joint surgery; (6) Patients with cognitive impairment and mental disorders; (7) Women in lactation or pregnancy; (8) Patients unsuitable for MRI examination; (9) Patients allergic to the drugs or drug components in this study.

Design outcomes

Primary

MeasureTime frame
?T2 relaxation time;Whole Organ Magnetic Resonance Imaging Score;

Secondary

MeasureTime frame
The Western Ontario and McMaster Universities Osteoarthritis Index;Visual Analogue Scale?;Aggrecan;Osteoprotegerin;Receptor Activator of Nuclear Factor-? B Ligand;

Countries

China

Contacts

Public ContactChen Peng

The Third People's Hospital affiliated to Fujian University of Traditional Chinese Medicine

963951499@qq.com18650332836

Outcome results

None listed

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