Clinical trial NCT02517957: Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Eczema
Keywords: Xiashi surgical
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the Eczema Area and Severity Index (EASI) score
timeFrame: Baseline and up to week 4 of the follow up phase
Secondary outcomes:
measure: Dermatology life quality index (DLQI)
timeFrame: Baseline and up to week 4 of the follow up phase
measure: Change in Itching degree score
timeFrame: Baseline and up to week 4 of the follow up phase
Other outcomes:
Locations:
Study officials:
References: