Chronic prurigo nodularis
Conditions
Interventions
Experimental Group:Wushe Zhiyang pill is taken orally and dupilumab is injected
Control group:Oral placebo plus injection of dupilumab
Sponsors
Wuhan No.1 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) In accordance with the western medical diagnostic criteria of prurigo nodosa; (2) According to TCM syndrome differentiation it is rheumatism toxin accumulation syndrome; (3) Age: 18-65 years old (including boundary value) regardless of gender; (4) Prurigo nodularis diagnosed by a dermatologist for at least 3 months; (5) the total number of lesions on the trunk or limbs =20; (6) WI-NRS=7 (0-10) within 7 days after admission; (7) a 2-week history of treatment failure of moderate to severe TCS or TCS is not medically recommended; (8)They voluntarily participated in this study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: Those with the syndrome of spleen deficiency and dampness accumulation in traditional Chinese medicine diagnosis; (2) Patients with other skin diseases that can cause itching; (3) Those with severe cardiovascular and cerebrovascular diseases or tumors; (4) Patients with abnormal laboratory indicators: serum creatinine (SCr) exceeds (not including) the upper limit of the normal value; alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and ?-glutamyl transpeptidase (GGT) exceed (not including) 1.5 times the upper limit of the normal value; total bilirubin (TBIL) exceeds (not including) 1.5 times the upper limit of the normal value; (5) Patients who received treatment with glucocorticoids or immunosuppressants within 2 weeks before screening; (6) Patients who used biologics within 3 months before screening; (7) Patients who received traditional Chinese medicine treatment such as herbs or acupuncture, judged by the researchers to affect the efficacy assessment of nodular pruritus, within 1 week before screening; (8) Patients allergic to the test drug or its components; (9) Pregnant, lactating, or those with a recent fertility plan; (10) Subjects who used the test drug or participated in other clinical trials within 3 months before screening; (11) Subjects considered unsuitable to participate in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a =4-point reduction from baseline on the 24-hour worst-itch numerical rating scale (WI-NRS);Single-cell RNA sequencing of skin lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Worst Itching Intensity Numerical Rating Scale (WI-NRS);Proportion of patients with a =4-point reduction from baseline on the 24-hour worst-itch numerical rating scale (WI-NRS);The proportion of patients with Investigator's Global Assessment for Prurigo Nodularis-Stage(IGA PN-S) of 0 or 1;Sleep Disturbance Numerical Rating Scale (SD-NRS);Dermatology Life Quality Index (DLQI);Hospital Anxiety and Depression Scale (HADS);Immunoglobulin E;recurrence rate;Proportion of subjects receiving rescue therapy; | — |
Countries
China
Contacts
Public ContactXianyu Zeng
Wuhan No.1 Hospital
Outcome results
None listed