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Clinical Study of Hai Tong Pi prescription for cold-dampness type knee osteoarthritis

Clinical Study of Hai Tong Pi prescription for cold-dampness type knee osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002329
Enrollment
Unknown
Registered
2025-11-28
Start date
2023-01-01
Completion date
Unknown
Last updated
2025-12-08

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 +Haitongpi decoction fumigation and washing
Control group:Basic treatment+Voltaren for external use

Sponsors

Wangjing hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meets KOA diagnostic criteria with Kellgren-Lawrence radiographic grading of Grade I or II; (2) Meets the aforementioned TCM diagnostic criteria and is pattern-differentiated as wind-cold-dampness bi syndrome; (3) Age =40 years and =75 years; (4) Good mental status with no concomitant cardiovascular, rheumatic immune, endocrine, or other systemic diseases; (5) No prior use of other medications or treatments within one month before treatment initiation; no other relevant treatments affecting this study; (6) Complete clinical records, good patient compliance, and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the KOA diagnostic criteria or have a Kellgren-Lawrence radiographic grade other than grade 1; (2) Those who do not meet the Traditional Chinese Medicine diagnosis of wind-cold-dampness arthralgia; (3) Those whose age does not meet the inclusion criteria; (4) Those with severe concomitant cardiovascular, rheumatic immune, endocrine, or other systemic diseases, or those with mental or cognitive impairments preventing completion of clinical observation; (5) Patients who have taken oral nonsteroidal anti-inflammatory drugs (NSAIDs), undergone arthroscopic procedures, or received joint replacement surgery within the past 4 weeks; (6) Patients with significant knee trauma or skin conditions affecting the affected limb, including skin lesions, gangrene, infection, or other peripheral vascular diseases; (7) Women who are pregnant or breastfeeding; (8) Patients currently participating in other clinical trials or who refuse to sign the informed consent form;

Design outcomes

Primary

MeasureTime frame
Visual analogue scales, VAS;Western Ontario and McMaster University, WOMAC;

Secondary

MeasureTime frame
Knee Joint Pain Threshold Measurement;Knee Joint Range of Motion Measurement;Traditional Chinese Medicine Symptom Grading Scale;

Countries

China

Contacts

Public ContactZHANG Qing

Wangjing Hospital of China Academy of Chinese Medical Sciences

zhangqinggys@163.com13641278072

Outcome results

None listed

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