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A Clinical Efficacy Observation Study of Zhuanggu Jianxi Decoction for the Treatment of Knee Osteoarthritis

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001309
Enrollment
Unknown
Registered
2026-05-26
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-06-01

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:Diacerein Capsules

Sponsors

Fujian University of Traditional Chinese Medicine Affiliated Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for KOA; (2) Meets the criteria for TCM syndrome differentiation; (3) Unilateral KOA with radiographic X-ray K-L grading: Grade II-III, accompanied by joint space narrowing, subchondral bone cystic changes, or sclerosis; (4) Age between 50 and 75 years, gender unrestricted; (5) No KOA-related treatment within the past 3 months, including oral medications, intra-articular drug injections, or non-drug therapies; (6) Patients willing to accept and actively cooperate with this study, and sign the informed consent form for clinical research.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of knee joint trauma and other secondary KOA; (2) Patients with failure of important organs such as heart, liver, and kidneys; (3) Patients with malignant tumors or benign tumors in the knee joint area; (4) Patients with rheumatoid arthritis, ankylosing spondylitis, gout, metabolic bone diseases, or other severe conditions; (5) Patients with a history of knee joint surgery; (6) Patients with cognitive impairments or mental illnesses; (7) Women in lactation or pregnancy; (8) Patients unsuitable for MRI examination; (9) Patients allergic to the drugs or components used in this study.

Design outcomes

Primary

MeasureTime frame
Transverse relaxation time;Whole-Organ Magnetic Resonance Imaging Score;

Secondary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index ;Visual Analog Scale;Aggrecan;Matrix Metallopeptidase 13;Osteoprotegerin;Receptor Activator of Nuclear Factor-? B Ligand;Beclin1;Microtubule-associated protein 1 light chain 3;

Countries

China

Contacts

Public ContactChen Peng

Fujian University of Traditional Chinese Medicine Affiliated Third People's Hospital

963951499@qq.com18650332836

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026