Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine

NCT ID: NCT05042635

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ixekizumab+Jueyin Granules

Intervention Type: 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 (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.

Group Type: PLACEBO_COMPARATOR

Ixekizumab+Jueyin placebo Granules

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. It conforms to the western diagnostic criteria of plaque psoriasis and the diagnostic criteria of TCM syndrome of blood heat syndrome;

2. Physician global assessment (PGA) ≥3, psoriasis area and severity index (PASI) score ≥12, and body surface area (BSA) ≥ 10% at screening and baseline;

3. Aged between 18 and 70;

4. Those who voluntarily participate in the study and sign the informed consent.

Exclusion Criteria

1. Erythrodermic psoriasis patients, arthropathic psoriasis patients, pustular psoriasis patients;

2. There are other active skin diseases that may affect the evaluator;

3. Have systematically received other investigational drugs within 1 month;

4. Received external glucocorticoid and phototherapy within 2 weeks;

5. During a period of severe and uncontrollable local or systemic acute or chronic infection;

6. Infected persons with tuberculosis;

7. Patients with viral hepatitis;

8. Serious systemic disease; Or clinical test indicators belong to one of the following cases of patients: alanine aminotransferase or glutamic-oxalacetic transaminase increase > 1.5 times the upper limit of normal value; Creatinine increase > 1.5 times the upper limit of normal value; Any one of the major blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) is lower than the lower limit of normal value; Or other abnormal laboratory tests determined by the investigator to be unsuitable for the study;

9. Patients with a history of malignant tumor and patients with primary or secondary immune deficiency and hypersensitivity;

10. Participants in clinical trials of other drugs within 3 months;

11. Those who have undergone major surgery within 8 weeks or will require such surgery during the study period;

12. For fertile women of childbearing age who did not use highly effective contraception from the screening period until the end of the last dose;

13. Pregnant or lactating women;

14. Persons with a history of alcohol, drug or substance abuse;

15. Persons with a serious history of mental illness or family history;

16. For other reasons, the researcher considers it inappropriate to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Skin Disease and Venereal Disease Hospital

OTHER

Sponsor Role: collaborator

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bin Li

Role: STUDY_CHAIR

Shanghai Skin Disease Hospital, School of Medicine, Tongji University

Central Contacts

Bin Li

Role: CONTACT

18930568129@163.com

0086-0021-55981301

Xin Li

Role: CONTACT

13661956326@163.com

0086-13661956326

Other Identifiers

21Y21920100

Identifier Type: -

Identifier Source: org_study_id