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| Name | Class |
|---|---|
| Shanghai Skin Disease and Venereal Disease Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixekizumab (4 weeks) + Jueyin Granules (12 weeks) | Experimental | 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. |
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| Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks) | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis area and severity index (PASI) | Psoriasis area and severity index (PASI) score and recurrence assessment. Psoriasis area and severity index (PASI) scores were assessed for all patients at each follow-up. Recurrence was defined as a 50% reduction in maximum PASI improvement from baseline at week 40. | Up to 168 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Body surface area (BSA) | The percentage of BSA involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%). | Up to 168 days after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Li | Contact | 0086-0021-55981301 | 18930568129@163.com | |
| Xin Li | Contact | 0086-13661956326 | 13661956326@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Li | Shanghai Skin Disease Hospital, School of Medicine, Tongji University | Study Chair |
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| 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. |
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| Physician Global Assessment (PGA) | Physician Global Assessment (PGA)is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I),desquamation (D) across all psoriatic lesions. lt is calculated as follows: PGA score = (E +I+D) / 3 then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0)-Very Severe (5)]. | Up to 168 days after treatment |
| Dermatology Life quality index(DLQI) | The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life. | Up to 168 days after treatment |
| Patient-reported quality of life (PRQoL) | PRQoL is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life. | Up to 168 days after treatment |
| Visual Analogue Score (VAS) | Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis). | Up to 168 days after treatment |
| CM symptom score | The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment. | Up to 168 days after treatment |