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Clinical Characteristics and Biomarker Research on the Evolution of Kidney Deficiency Syndrome in Early and Middle Stages of Knee Osteoarthritis (KOA)

Clinical Characteristics and Biomarker Research on the Evolution of Kidney Deficiency Syndrome in Early and Middle Stages of Knee Osteoarthritis (KOA)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000174
Enrollment
Unknown
Registered
2026-01-24
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Osteoarthritis

Interventions

Sponsors

The First Affiliated Hospital of Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for KOA Subjects with Kidney Deficiency Syndrome: 1) Age: 60-75 years, regardless of gender. 2) Diagnosed with OA based on X-ray/magnetic resonance imaging (MRI)/clinical symptoms. 3) Kellgren & Lawrence grade between 0 and II. 4) Meeting the Traditional Chinese Medicine (TCM) syndrome differentiation criteria for Kidney Deficiency Syndrome (including Kidney Yin Deficiency, Kidney Yang Deficiency, or Kidney Yin-Yang Deficiency). 5) Agreement to participate in this study and provision of signed informed consent. Inclusion Criteria for Healthy Control Group: 1) Age: 60-75 years, regardless of gender. 2) Not meeting the diagnostic criteria for KOA. 3) Not meeting the diagnostic criteria for Kidney Deficiency Syndrome. 4) In good general health with no other major diseases affecting health status. 5) Agreement to participate in this study and provision of signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Secondary arthritis: Rheumatoid arthritis, ankylosing spondylitis, gouty arthritis, infectious arthritis, traumatic arthritis, etc. 2) Severe joint structural abnormalities: Deformed, disabled, or dysfunctional knee joints. 3) Complicated with systemic diseases: Severe heart, liver, or kidney failure, malignant tumors, blood system diseases, immune deficiencies, tuberculosis, hemophilia, mental disorders, etc. 4) Received joint cavity injections (such as hormones, hyaluronic acid) within the past month, or have been taking long-term hormones or immunosuppressants. 5) Women who may be pregnant or planning to get pregnant.

Design outcomes

Primary

MeasureTime frame
Kidney Deficiency Score and Therapeutic Effect Evaluation Scale;WOMAC Score Scale;HSS Score Scale;Degree of swelling in the knee joint;VAS pain score;

Secondary

MeasureTime frame
Measurement of X-ray joint space width and bone spurs;MRI MOAKS Rating Scale;

Countries

China

Contacts

Public Contacthuantian Zhang

The First Affiliated Hospital of Jinan University, No. 613, West Huangpu Avenue, Tianhe District, Guangzhou City, Guangdong Province

zhanghuantian@jnu.edu.cn+86 188 2079 7138

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026