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An open, multicenter phase IV clinical study to evaluate the efficacy and safety of Sheila Shenhuang ointment in the treatment of superficial fungal disease

An open, multicenter phase IV clinical study to evaluate the efficacy and safety of Sheila Shenhuang ointment in the treatment of superficial fungal disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015095
Enrollment
Unknown
Registered
2018-03-07
Start date
2018-03-26
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

Shallow fungal disease

Interventions

Case series:Serpentine yellow ointment

Sponsors

Hunan University of Chinese Medicine Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 6-75 years of age male and female; 2. meet the clinical diagnostic criteria for superficial fungal disease; 3. Skin area less than 40 % of BSA; 4. Voluntary participation in the experiment and signature of the informed consent; 5. Within one month from the date of signing the informed consent form until the last delivery, the subjects or their partners agreed to take the contraceptive measures approved by the researchers.

Exclusion criteria

Exclusion criteria: 1. A ringworm; 2. Stimulating more serious bacterial infections with fever, red poison, cellulitis; 3. Patients with other apparent skin conditions(such as contact dermatitis or suppurative infection) that may affect the evaluation of the efficacy; 4. Allergies to known components of the drug tested, or to an allergic constitution; 5. ALT, AST > 1.5 times normal range upper limit; Cr > 1.5 normal value range upper limit; 6. Drugs(such as glucocorticoids, immunosuppressants, antifungal, bacterial and antihistamines) that are required to be applied in whole or in part during the two weeks preceding the selection or during the trial; 7. Pregnancy and lactation; 8. Persons who have participated or are participating in other clinical trials within three months; 9. Other cases judged unsuitable for participation in clinical trials.

Design outcomes

Primary

MeasureTime frame
Target Skin Damage;Effect of itching;Qualitative detection of fungi;

Secondary

MeasureTime frame
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 ContactYang Zhibo

Second Affiliated Hospital, Hunan University of Traditional Chinese Medicine

dr.yang888@126.com+86 13973165902

Outcome results

None listed

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