Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Study ID
NCT05042635
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Ixekizumab+Jueyin Granules — DRUG
    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.
  • Ixekizumab+Jueyin placebo Granules — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 1, 2021
Status verified
Sep 2021
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ixekizumab (4 weeks) + Jueyin Granules (12 weeks)
    Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin Granules was used in the 12-week traditional Chinese medicine treatment period.
  • Placebo Comparator: Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks)
    Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin placebo Granules was used in the 12-week traditional Chinese medicine treatment period.

Primary Outcome Measure

Psoriasis area and severity index (PASI) [ Time Frame: Up to 168 days after treatment ]

Central Contacts

Related Studies