Back to results

Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research

Primary Purpose

Eczema

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Furoic acid loperamide hydrochloride cream

Mullite ointment

3% boric acid solution

Zine oxide

About this trial

This is an interventional treatment trial for Eczema focused on measuring Xiashi surgical

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Qinzhuliangxue Keli

loratadine tablets

Qinzhuliangxue and loratadine

Arm Description

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.)

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.).

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.).

Outcomes

Primary Outcome Measures

Change from Baseline in the Eczema Area and Severity Index (EASI) score

Secondary Outcome Measures

Dermatology life quality index (DLQI)

Change in Itching degree score

Full Information

NCT ID

NCT02517957

First Posted

August 5, 2015

Last Updated

August 6, 2015

Sponsor

Shanghai Yueyang Integrated Medicine Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02517957

Brief Title

Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Yueyang Integrated Medicine Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eczema

Keywords

Xiashi surgical

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

342 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Qinzhuliangxue Keli

Arm Type

Experimental

Arm Description

Arm Title

loratadine tablets

Arm Type

Active Comparator

Arm Description

Arm Title

Qinzhuliangxue and loratadine

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Furoic acid loperamide hydrochloride cream

Intervention Description

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

Intervention Name(s)

Mullite ointment

Intervention Description

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

Intervention Name(s)

3% boric acid solution

Intervention Description

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

Intervention Name(s)

Zine oxide

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline in the Eczema Area and Severity Index (EASI) score

Time Frame

Baseline and up to week 4 of the follow up phase

Secondary Outcome Measure Information:

Title

Dermatology life quality index (DLQI)

Time Frame

Baseline and up to week 4 of the follow up phase

Title

Change in Itching degree score

Time Frame

Baseline and up to week 4 of the follow up phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Bin, director

Phone

0086-021-65162629

18930568129@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Li Fulun, researcher

Phone

0086-021-65162629

drlifulun@163.com

12. IPD Sharing Statement

Learn more about this trial

Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research

We'll reach out to this number within 24 hrs