A multicenter, randomized, double-blind, placebo-controlled clinical study of Wushe Zhiyang Pill in treating eczema (syndrome of blood deficiency and wind-dryness)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400085887

Enrollment

Unknown

Registered

2024-06-20

Start date

2024-07-01

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

eczema

Interventions

experimental group:Wushe Zhiyang Pill

control group:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic standards of Western medicine for eczema; (2) Meet the diagnostic standards of Chinese medicine for eczema(syndrome of blood deficiency and wind-dryness); (3) Age: 18-65 years old , both male and female; (4) IGA:2-3; (5) BSA:<10%; (6) Subjects voluntarily joined the study, signed written informed consent.

Exclusion criteria

Exclusion criteria: (1)Patients with other skin disorders causing itching; (2) Eczema in specific areas (perianal, vulva, scrotum, breast, etc.; (3)Patients with severe cardiovascular and cerebrovascular diseases and tumors; (4)Abnormal laboratory indicators: serum creatinine (SCr) exceeding (excluding) the upper limit of normal; Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and ?-glutamyl transpeptidase (GGT) were 1.5 times higher than the upper limit of normal value. Total bilirubin (TBIL) more than 1.5 times the upper limit of normal (excluding); (5)Systemic or topical use of glucocorticoids (including weak, medium, strong and super potent glucocorticoids) and immunosuppressants within 2 weeks before screening; (6)patients using biological agents within 3 months prior to screening; (7) patients using Chinese medicine, acupuncture and other traditional Chinese medicine treatment that the researchers judged to affect the evaluation of the efficacy of eczema within 1 week before screening; (8)Patients who are allergic to the investigational drug or its components; (9)Patients who are pregnant, lactating, or recently planning to have a baby; (10)Participants who had used the investigational drug or participated in other clinical trials within the preceding 3 months were screened; (11)Subjects deemed unsuitable for the study by the investigator.

Design outcomes

Primary

Measure	Time frame
Changes in eczema area and severity index;	—

Secondary

Measure	Time frame
Eczema area and severity index, EASI;EASI-50%, 75%, 90% ratio;DLQI;IGA;VAS;IGE;TCM syndrome;recurrence rate;Remedial treatment ratio;Remedial therapeutic dosage;	—

Countries

China

Contacts

Public ContactDongmei Zhou

Beijing Hospital of Traditional Chinese Medicine

807833656@qq.com+86 131 2015 7993

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026