NCT05042635

Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

A Multi-center, Randomized, Double-blind Controlled Study on the Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shanghai Yueyang Integrated Medicine Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to objectively and standardly evaluate the clinical efficacy and safety of sequential treatment of psoriasis with traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.

Detailed description

Psoriasis is a chronic, recurrent, inflammatory disease. The incidence of this disease is increasing year by year, seriously affecting people's quality of life. Biologic agents have the advantages of rapid and efficient treatment of moderate and severe psoriasis, but their safety and recurrence are still seriously affect the application. Traditional Chinese medicine treatment of psoriasis has the advantages of fewer adverse reactions, low recurrence rate and improvement of patients' systemic symptoms while exerting the curative effect. The prevention and treatment of psoriasis by combining traditional Chinese and Western medicine has become the academic consensus. The sequential treatment of psoriasis with biological agents combined with Traditional Chinese medicine has a better therapeutic effect than that of single therapy. At present, the sequential treatment of psoriasis with targeted biological agents combined with traditional Chinese medicine has not been reported in the literature, and there is a lack of high-level clinical evidence to support it. Therefore, this project aims to provide evidence support for the clinical efficacy and safety of sequential treatment of psoriasis by traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Ixekizumab+Jueyin Granules	Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once). Jueyin Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times.
DRUG	Ixekizumab+Jueyin placebo Granules	Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once). Jueyin placebo Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times.

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2021-09-13
• Last updated: 2021-09-13