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Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02517957
Enrollment
342
Registered
2015-08-07
Start date
2015-08-31
Completion date
Unknown
Last updated
2015-08-07

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

Conditions

Eczema

Keywords

Xiashi surgical

Brief summary

On the basis of Xiashi skin surgery clinical experience, this project adopts the multicenter, randomized, double-blind, controlled trial of design type. Objective, normative evaluation of traditional Chinese medicine cool blood latent town effectiveness of therapeutic regimen in the treatment of eczema, security, and control of the relapse of situation, provide high-level evidence-based basis for traditional Chinese medicine treatment of eczema, aims to form suitable for popularization and application of traditional Chinese medicine in the treatment of eczema.

Interventions

DRUGFuroic acid loperamide hydrochloride cream

Apply to lesion area without erosion, drainage, 1 times a day, continuous use 1 week after according to disease reduction or withdrawal, the longest do not exceed 4 weeks. Pure dry area or no skin itching area should not be applied.

DRUGMullite ointment

Applies to a blister, pustule, erosion, ulcer, leaking or comorbid folliculitis, in skin lesions of 2 times a day, 5 days for one period of treatment, but for two consecutive period of treatment

DRUG3% boric acid solution

3% boric acid solution is suitable for the erosion seepage skin, can open intermittent shi fu, 5-10 min each time, 2 times daily or several times.

DRUGZine oxide

In wet apply the break to zinc oxide preparation for external use only, when erosion seepage control is disabled in skin lesions.

Sponsors

Shanghai Yueyang Integrated Medicine Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* accord with standard of syndrome differentiation of traditional Chinese medicine (blood hot sheng) and western medicine diagnostic criteria (subacute eczema); * age between 18-65 years old, gender, ethnic unlimited; * agreed to participate in clinical trials can observe and cooperate with the visitor on schedule; * volunteered for this study and obtain informed consent will be; * lesion area of about 5-30% of surface area (BSA) were (containing 3% and 3%, palm measurement method) * IGA scale of 1 to 3 points (including); * her lesions mainly located in the trunk and limbs (or); * Women HCG negative;

Exclusion criteria

* known to the study of drug allergy to any of the components; * previous or current with any may affect the results of systemic disease, or other activity of skin diseases (such as: psoriasis); * has a liver and kidney function is not complete, liver damage of ALT and AST \> 1.5 times the upper limit of normal, renal BUN \> 1.5 times the upper limit of normal or creatinine \> 1.5 times the upper limit of normal value; * QTcB or QTcF acuity 450 milliseconds. For subjects QTc acuity bundle branch block 480 milliseconds. * prior or current with clinical significance of cardiovascular, lung disease, gastrointestinal tract, liver, kidney, blood, nerve abnormalities or mental disease; * breast-feeding or plan to pregnant women during test; * skin area score \> 30%; * eosinophil count score \> 10% * for nearly two weeks taking corticosteroids or a week, both inside and outside with corticosteroid preparation; * three months received study medication or other participated in other clinical subjects; * for any reason cannot cooperate research, for example: how language understanding, not to research centers, etc.; * Researchers believe can bring obvious risk patients or confuse the results of the study, which should rule out other conditions or disease.

Design outcomes

Primary

MeasureTime frame
Change from Baseline in the Eczema Area and Severity Index (EASI) scoreBaseline and up to week 4 of the follow up phase

Secondary

MeasureTime frame
Dermatology life quality index (DLQI)Baseline and up to week 4 of the follow up phase
Change in Itching degree scoreBaseline and up to week 4 of the follow up phase

Contacts

Primary ContactLi Bin, director
18930568129@163.com0086-021-65162629
Backup ContactLi Fulun, researcher
drlifulun@163.com0086-021-65162629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026