Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research

NCT ID: NCT02517957

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31

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.

Conditions

Eczema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Qinzhuliangxue Keli

Qinzhuliangxue 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.)

Group Type: EXPERIMENTAL

Furoic acid loperamide hydrochloride cream

Intervention Type: DRUG

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.

Mullite ointment

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Zine oxide

Intervention Type: DRUG

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

loratadine tablets

Qinzhuliangxue 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.).

Group Type: ACTIVE_COMPARATOR

Furoic acid loperamide hydrochloride cream

Intervention Type: DRUG

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.

Mullite ointment

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Zine oxide

Intervention Type: DRUG

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

Qinzhuliangxue and loratadine

Qinzhuliangxue 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.).

Group Type: ACTIVE_COMPARATOR

Furoic acid loperamide hydrochloride cream

Intervention Type: DRUG

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.

Mullite ointment

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Zine oxide

Intervention Type: DRUG

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

Interventions

Furoic 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.

Intervention Type: DRUG

Mullite 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

Intervention Type: DRUG

3% 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.

Intervention Type: DRUG

Zine oxide

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Li Bin, director

Role: CONTACT

18930568129@163.com

0086-021-65162629

Li Fulun, researcher

Role: CONTACT

drlifulun@163.com

0086-021-65162629

Other Identifiers

14401970200

Identifier Type: -

Identifier Source: org_study_id