Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02517957
Previous Study | Return to List | Next Study

Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02517957
Recruitment Status : Unknown
Verified August 2015 by Shanghai Yueyang Integrated Medicine Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 7, 2015
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Shanghai Yueyang Integrated Medicine Hospital

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.

Condition or disease Intervention/treatment Phase
Eczema Drug: Furoic acid loperamide hydrochloride cream Drug: Mullite ointment Drug: 3% boric acid solution Drug: Zine oxide Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2015
Estimated Primary Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 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.)
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.

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

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.

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.

Active Comparator: 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.).
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.

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

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.

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.

Active Comparator: 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.).
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.

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

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.

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.




Primary Outcome Measures :
  1. 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 Measures :
  1. Dermatology life quality index (DLQI) [ Time Frame: Baseline and up to week 4 of the follow up phase ]
  2. Change in Itching degree score [ Time Frame: Baseline and up to week 4 of the follow up phase ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517957


Contacts
Layout table for location contacts
Contact: Li Bin, director 0086-021-65162629 18930568129@163.com
Contact: Li Fulun, researcher 0086-021-65162629 drlifulun@163.com

Sponsors and Collaborators
Shanghai Yueyang Integrated Medicine Hospital
Layout table for additonal information
Responsible Party: Shanghai Yueyang Integrated Medicine Hospital
ClinicalTrials.gov Identifier: NCT02517957    
Other Study ID Numbers: 14401970200
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Keywords provided by Shanghai Yueyang Integrated Medicine Hospital:
Xiashi surgical
Additional relevant MeSH terms:
Layout table for MeSH terms
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Loperamide
Antidiarrheals
Gastrointestinal Agents