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A Randomized Controlled Trial of Sanfutie for Cold-damp Syndrome of Knee Osteoarthritis

Efficacy and safety of Sanfutie in Treatment of Knee Osteoarthritis: A single center, randomized, double-blind, parallel placebo controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016880
Enrollment
Unknown
Registered
2018-06-30
Start date
2018-06-29
Completion date
Unknown
Last updated
2018-07-02

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

Conditions

Knee Osteoarthritis

Interventions

Treatment Group:Sanfutie
Control Group:Placebo

Sponsors

Wuxi People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
38 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of knee osteoarthritis; 2. Meet the diagnostic criteria of traditional Chinese medicine for osteopalgia(Gubi); 3. Meet the diagnostic criteria of cold damp syndrome; 4. Aged between 38 and 80 years old; 5. The patient has been informed and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Participants suffered from infectious arthritis, gout arthritis, rheumatoid arthritis, traumatic arthritis; (2) Participants suffered from diabetes; (3) Participants who were allergic constitution or susceptible or were allergic to the components of the study drugs; (4) Participants suffered from severe hepatic and renal insufficiency (ALT = 3 times the upper limit of normal value, Cr=3mg/dL); (5) Participants had severe cardiovascular, metabolic, Hematopoietic, neurological, cancer, tumor or who were excluded by the investigators; (6) Lactating and pregnant women or women of childbearing age who were planning pregnancy; (7) Participants suffered from psychiatric disorders; (8) Participants had participated in other clinical trials within 3 month; (9) The participants who were assessed by researchers that could not complete the study or could not comply with the requirements of the study.

Design outcomes

Primary

MeasureTime frame
WOMAC-VAS;

Secondary

MeasureTime frame
ESR;numeric pain rating scale;TCM syndrome score scale;50 yards (46 meters) for maximum walking distance;Michel Lequesen;

Countries

China

Contacts

Public ContactJiaying Wang

The Affliated Wuxi People's Hospital of Nanjing Medical University

15922101193@163.com+86 15261503999

Outcome results

None listed

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