Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research

Eczema Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02517957
• Other study ID #: 14401970200
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 5, 2015
• Last updated: August 6, 2015
• Start date: August 2015

Study information

• Verified date: August 2015
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: Li Bin, director
• Phone: 0086-021-65162629
• Email: 18930568129[@]163.com
• Is FDA regulated: No
• Health authority: China:Nanjing NingQi pharmaceutical technology co., LTD
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 342
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eczema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Eczema Area and Severity Index (EASI) score		Baseline and up to week 4 of the follow up phase	No
Secondary	Dermatology life quality index (DLQI)		Baseline and up to week 4 of the follow up phase	No
Secondary	Change in Itching degree score		Baseline and up to week 4 of the follow up phase	No