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Efficacy and safety of Tripterygium wilfordii Hook F in the treatment of patients with synovitis, acne, pustulosis, hyperostosis, and osteitis syndrome

Efficacy and safety of Tripterygium wilfordii Hook F in the treatment of patients with synovitis, acne, pustulosis, hyperostosis, and osteitis syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025912
Enrollment
Unknown
Registered
2019-09-14
Start date
2019-02-12
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

Synovitis, acne, pustulosis, hyperostosis, and osteitis syndrome

Interventions

1.5mg treatment group:1.5mg/(kg*d) dose of oral Tripterygium wilfordii Hook F, taking in 2-3 times a day, post meal
dosage starts to reduce after 5-week treatment until reaching 1.0mg/(kg*d) at the end of 12-week follow-up
1.0mg treatment group:1.0mg/(kg*d) dose of oral Tripterygium wilfordii Hook F, taking in 2-3 times a day, post meal
dosage remains constant for 12 weeks

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
29 Years to 66 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18–70 years; 2) In accordance with the diagnostic criteria of SAPHO reported by Kahn in 2003; 3) ASDAS-CRP=1.3 4) VAS=4.

Exclusion criteria

Exclusion criteria: 1) Pregnant or lactating women; 2) With a desire to have children; 3) csDMARDs or biological therapy within 3 months before recruitment; 4) Severe cardiac, hepatic, renal dysfunction; 5) Significant abnormalities in hematology, including anemia, thrombocytopenia, leukopenia.

Design outcomes

Primary

MeasureTime frame
Change from baseline in ASDAS;

Secondary

MeasureTime frame
The proportion of patients achieving VAS50;The proportion of patients achieving BASDAI50;The proportion of patients achieving ASDAS2.1, ASDAS1.3, ASDAS-CII, ASDAS-MI;Change from baseline in global bone pain;Change from baseline in BASDAI;

Countries

China

Contacts

Public ContactChen Li

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

casio1981@163.com+86 13810988688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026