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A prospective, multicenter, 2×2 factorial design real-world study comparing the effect of Peiyuan Tongbi ointment combined with different levels of acupuncture on knee preservation in patients wit

A prospective, multicenter, 2×2 factorial design real-world study comparing the effect of Peiyuan Tongbi ointment combined with different levels of acupuncture on knee preservation in patients wit

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006034
Enrollment
Unknown
Registered
2022-05-25
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Knee Osteoarthritis

Interventions

Basic treatment group:manual therapy
Peiyuan Tongbi ointment treatment group:Apply Peiyuan Tongbi ointment
Acupuncture combined with Peiyuan Tongbi ointment treatment group:Acupuncture combined with Peiyuan Tongbi ointment

Sponsors

Xinjiang Uygur Autonomous Region Institute of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) KOA patients who meet the diagnostic criteria of Western medicine and TCM dialectical classification; (2) Patients who are willing to accept conservative treatment; (3) Informed consent, voluntary subjects, and those who signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) mentally ill patients; (2) Patients who cannot understand, cannot accurately express, or cannot complete follow-up due to other irresistible factors; (3) Patients who have undergone KOA surgery on the affected side (received arthroscopic surgery within 2 years); (4) Those with a history of opioid analgesics, sedative-hypnotics and alcohol abuse; (5) Other diseases of the knee joint, such as tuberculosis of the knee joint, tumors, infectious diseases of the knee joint, such as suppurative knee arthritis or osteomyelitis, recent history (within 2-3 weeks) of knee joint trauma; damage to the skin around the joint , patients with vascular nerve injury; (6) Patients participating in this study during the study period cannot participate in other KOA-related studies.

Design outcomes

Primary

MeasureTime frame
KOA recurrence frequency;annual recurrence rate;knee replacement surgery time;Mean time between relapses within 2 years;

Secondary

MeasureTime frame
IL-1ß;lymphatic clearance rate around the knee joint;IL-6;WOMAC scale;VAS score;Lequesne Index;Plantar pressure parameters;

Countries

China

Contacts

Public ContactRui Fang
xjqzyykj@126.com13609985551

Outcome results

None listed

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