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The Clinical Efficacy Evaluation and Mechanism of Action Study of Hai Tong Pi Formula Fumigation and Washing as Adjuvant Therapy for Knee Osteoarthritis

The Clinical Efficacy Evaluation and Mechanism of Action Study of Hai Tong Pi Formula Fumigation and Washing as Adjuvant Therapy for Knee Osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002620
Enrollment
Unknown
Registered
2025-12-30
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-12

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:Basic treatment + Oral non-steroidal anti-inflammatory and analgesic drugs + Eurya emarginata decoction for fumigation and washing
Control Group:Basic treatment plus oral nonsteroidal anti-inflammatory and analgesic drugs.

Sponsors

Yellow River Sanmenxia Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Patients who meet the diagnostic criteria for knee osteoarthritis (unilateral or bilateral); 2) Patients who meet the diagnostic criteria for cold-damp obstruction syndrome in traditional Chinese medicine for knee osteoarthritis; 3) Patients aged between 50-70 years, with no gender restrictions; 4) Patients with a disease duration of knee osteoarthritis = 3 months; 5) Knee joint X-ray K-L grading belongs to Grade I-II; 6) The staging of knee osteoarthritis belongs to the initial or early stage; 7) Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score < 12 points; 8) Visual Analog Scale (VAS) score between 3 and 5 points (inclusive); 9) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Those who have taken Chinese herbal decoctions, traditional Chinese medicine preparations, or other Western medications for the treatment of knee osteoarthritis within the past week; 2) Individuals with an allergy to sulfonamide drugs; 3) Patients with concurrent knee joint tumors, tuberculosis, rheumatism, rheumatoid arthritis, or gouty arthritis; 4) Patients who have undergone knee joint replacement surgery; 5) Pregnant women, those planning pregnancy, or breastfeeding women; 6) Patients with severe underlying conditions of the cardiovascular, cerebrovascular, or hematopoietic systems, mental illness, malignant tumors, or impaired liver or kidney function; 7) Individuals currently participating in other clinical trials that may affect the evaluation of this study's results.

Design outcomes

Primary

MeasureTime frame
The response rate of the Visual Analogue Scale for Pain;

Secondary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index Total Score;Western Ontario and McMaster Universities Osteoarthritis Index Subscale Score;Quality of Life Score (SF-12);Traditional Chinese Medicine syndrome score;

Countries

China

Contacts

Public ContactWang Yaosheng

Yellow River Sanmenxia Hospital

wangyaoshengsmx@163.com15003980254

Outcome results

None listed

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