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Evaluation of clinical efficacy and safety of traditional chinese medicine for oral and external use combined with physical therapy in patients undergoing knee arthroplasty

Clinical efficacy and safety of traditional chinese medicine for knee arthroplasty recovery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88754802
Enrollment
106
Registered
2025-12-18
Start date
2023-03-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

106 patients who underwent knee arthroplasty Musculoskeletal Diseases

Interventions

To ensure the randomness of the grouping, the 106 patients who underwent knee replacement were divided into experimental and control groups using the random number table method, with 53 patients in ea
for example, odd numbers in the random number table corresponded to the control group, and even numbers corresponded to the experimental group. Both groups were informed that they should consume a l

Sponsors

First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
59 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis is knee osteoarthritis, rheumatoid arthritis or knee dysfunction caused by trauma, in line with the indications of knee arthroplasty 2. Total knee arthroplasty or partial knee arthroplasty is planned 3. preoperative physical condition was good, with no serious medical diseases (e.g. heart disease, diabetes, liver or kidney dysfunction) 4. Patients or their legal guardians signed informed consent forms and agreed to participate in this study 5. Patients with appropriate psychological state, with no serious mental illness or cognitive impairment 6. Patients diagnosed with spleen-kidney deficiency syndrome (manifested as soreness and weakness of waist and knees, aversion to cold limbs, frequent nocturia, pale tongue with white coating, deep and thready pulse) confirmed by two senior TCM physicians

Exclusion criteria

Exclusion criteria: 1. With severe complications, such as uncontrolled hypertension, heart disease or other chronic diseases, that may affect postoperative recovery 2. With surgical contraindications such as infection around the knee joint and tumour 3. With a history of allergies to the TCM ingredients or anaesthetics involved in the study 4. Who have undergone other joint or major surgery in the last 6 months 5. With chronic pain syndrome or multiple pain disorders 6. Who were pregnant or lactating 7. Who could not follow the doctor’s instructions due to psychological factors or other reasons, or patients who may affect the results of the study 8. With damp-heat stasis syndrome (red tongue with yellow greasy coating, rapid pulse) due to potential aggravation by warming herbs in the formula

Design outcomes

Primary

MeasureTime frame
-

Countries

China

Contacts

Public ContactShuren Wang
wangshuren_w87@163.com+86 13904606969

Outcome results

None listed

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