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Multi-center phase ? clinical study for the safety and efficacy of Shezhishenhuang ointment in the treatment of eczema (damp heat and skin syndrome)

Multi-center phase ? clinical study for the safety and efficacy of Shezhishenhuang ointment in the treatment of eczema (damp heat and skin syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021089
Enrollment
Unknown
Registered
2019-01-28
Start date
2019-02-11
Completion date
Unknown
Last updated
2019-02-04

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

Conditions

Eczema

Interventions

test group:Shezhishenhuang ointment

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Western medicine diagnosis in line with eczema; 2. TCM syndrome standards in line with TCM moist heat and skin syndrome; 3. Aged 6 to 75 years, gender is not limited; 4. The area of skin lesions does not exceed 15% of the total surface area of the body; 5. The informed consent process is in compliance with the regulations and the informed consent form is signed. Minor, Aged 6 years and less than 8 years, the guardian signed the informed consent form; Aged 8 years and less than 18 years, the parents (guardians) and the minors signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. A skin lesion combined with a bacterial, viral or fungal infection and requiring an anti-infective treatment; 2. Those who are known or suspected to be allergic to the composition of the study drug; 3. Broken skin; 4. The skin is erosive, acute exudation; 5. There are serious central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and musculoskeletal system and mental disorders (ALT, AST exceeds the upper limit of the normal range of 2 times, Cr exceeds the upper limit of the normal range And other active skin diseases that may affect the outcome, such as psoriasis; 6. Those who have participated in other clinical trials within 4 weeks before enrollment; 7. Lactating or pregnant women; 8. Those who are known or suspected to have poor compliance cannot complete the test, such as alcoholism, drug dependence or mental illness. The investigator judges that it is not suitable for the clinical researcher.

Design outcomes

Primary

MeasureTime frame
Eczema Area and Severity Index;

Secondary

MeasureTime frame
Itching score;TCM syndrome evaluation;Vital signs;Medical examination;Blood routine;Urinary routine;Liver function;Renal function;12-channel electrocardiogram;Pregnancy test;Observation of adverse events(severity, incidence);

Countries

China

Contacts

Public ContactLi Linfeng

Beijing Friendship Hospital affiliated to Capital Medical University

zoonli@sina.com+86 13693620186

Outcome results

None listed

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