Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research
1 other identifier
interventional
342
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedAugust 7, 2015
August 1, 2015
2 years
August 5, 2015
August 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in the Eczema Area and Severity Index (EASI) score
Baseline and up to week 4 of the follow up phase
Secondary Outcomes (2)
Dermatology life quality index (DLQI)
Baseline and up to week 4 of the follow up phase
Change in Itching degree score
Baseline and up to week 4 of the follow up phase
Study Arms (3)
Qinzhuliangxue Keli
EXPERIMENTALQinzhuliangxue Keli(common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets placebo (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.)
loratadine tablets
ACTIVE COMPARATORQinzhuliangxue Keli placebo (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.),Loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
Qinzhuliangxue and loratadine
ACTIVE COMPARATORQinzhuliangxue Keli (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.).
Interventions
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.
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
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.
In wet apply the break to zinc oxide preparation for external use only, when erosion seepage control is disabled in skin lesions.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 7, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2017
Last Updated
August 7, 2015
Record last verified: 2015-08