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Protocol for a randomized, double-blind, placebo-controlled clinical study of the combination of Huayu Xiecang San fumigation and bisacodyl ryanin in the treatment of early to mid-stage osteoarthritis of the knee

Protocol for a randomized, double-blind, placebo-controlled clinical study of the combination of Huayu Xiecang San fumigation and bisacodyl ryanin in the treatment of early to mid-stage osteoarthritis of the knee

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000121
Enrollment
Unknown
Registered
2024-07-08
Start date
2024-10-10
Completion date
Unknown
Last updated
2024-07-23

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

Conditions

Knee osteoarthritis

Interventions

Observation group:Diacerein combined with Huayu Xiaozhong San
Control Group:Diacerein combined with placebo

Sponsors

Qingyang Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Complies with KOA Western medical diagnostic criteria, and meets K-L imaging grade 0-III (early, early, and mid stage); 2) Compliant with KOA Traditional Chinese Medicine diagnosis; 3) Age range: 50-70 years old; 4) Those who have recently undergone other conservative treatment methods must undergo a one week washout period; 5) Voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Secondary osteoarthritis, or other diseases or complications that can affect knee joint function; 2) Patients with sarcoidosis and acute knee joint trauma; 3) Individuals with local skin damage to the knee joint and other diseases affecting local medication; 4) Those who meet the criteria for damp heat obstruction syndrome in KOA traditional Chinese medicine diagnosis; 5) Individuals who have used steroids within 2 months and have undergone knee joint cavity injection and arthroscopy within 3 months; 6) Patients with combined important organ diseases and mental illnesses; 7) Individuals who are allergic to a certain traditional Chinese medicine in a double vinegar or fumigation formula; 8) Breastfeeding or pregnant women; 9) Participating in other clinical researchers; 10) Researchers evaluate easily lost patients based on their actual situation

Design outcomes

Primary

MeasureTime frame
Local tenderness value;Clinical total effective rate;Visual simulation pain scale method;The Osteoarthritis Index of the University of Western Ontario and McMaster University;Traditional Chinese Medicine Syndrome Points;

Secondary

MeasureTime frame
Adverse reactions;

Countries

china

Contacts

Public Contactwangshaofei

Qingyang Traditional Chinese Medicine Hospital

743220071@qq.com19996282324

Outcome results

None listed

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