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Clinical study of Huashui Xiaoyin formula combined with Secukinumab in the management of chronic psoriasis

Clinical study of Huashui Xiaoyin formula combined with Secukinumab in the management of chronic psoriasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000129
Enrollment
Unknown
Registered
2025-01-16
Start date
2022-08-17
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

psoriasis

Interventions

Control group:Secukinumab injection
Experimental Group:Secukinumab injection combined with oral administration of Huashixiaoyin prescription

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: A. Male or female aged 18 = = 75 years; B. Diagnosed with plaque psoriasis for = 6 months with or without psoriatic arthritis C. PGA = 3 PASI = 12 BSA = 10% at screening and baseline; D. Subjects who are intolerant to systemic treatment and/or phototherapy have contraindications or have poor treatment control and who are judged by the investigator to need systemic treatment. E. Subjects who meet the symptoms of psoriasis with spleen deficiency and dampness: According to the "Guidelines for Evidence-Based Clinical Practice of Traditional Chinese Medicine for Psoriasis Vulgaris (White Psoriasis) (2013 Edition)" and "Terms of Clinical Diagnosis and Treatment of Traditional Chinese Medicine·Syndrome Part".

Exclusion criteria

Exclusion criteria: A. History of psoriasis-related medication: history of topical medication in the previous 2 weeks history of traditional Chinese medicine medication in the previous month history of non-biological systemic medication or phototherapy; history of biological medication in the previous 3 months; history of Natalizumab Efalizumab or B cell or T cell regulator medication in the previous 12 months; B. BCG vaccination in the 12 months before treatment or live vaccine or bacterial vaccination in the 3 months; C. History of other systemic diseases; D. History of infection: history of infection with hepatitis B tuberculosis HIV etc.; history of chronic opportunistic and severe infection.

Design outcomes

Primary

MeasureTime frame
Time to relapse of patients during follow-up period from week 24 to week 48;

Secondary

MeasureTime frame
Percentage of TCM symptom improvement at week 24 and week 48;Percentage of patients with PASI 75 at week 24;Percentage of patients with PASI 50 and PASI 90 at week 24;Percentage of patients with relapse during the follow-up period from week 24 to week 48;

Countries

China

Contacts

Public ContactBai Yanping

China-Japan Friendship Hospital

zhi@tsinghua.edu.cn13910758509

Outcome results

None listed

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