Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

Last updated: September 19, 2016
Sponsor: Guizhou Tongjitang Pharmaceutical Co.,Ltd
Overall Status: Trial Status Unknown

Phase

4

Condition

Allergy

Atopic Dermatitis

Dermatitis, Atopic

Treatment

N/A

Clinical Study ID

NCT02601222
Z-RZZY-JN-RS
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consistent with diagnostic criteria for chronic eczema(Referring to "the Chineseeczema diagnosis and treatment guidelines" in 2011);

  • Investigator Global Assessment (IGA) score was 2 or 3;

  • The skin lesions were localized, hypertrophy and dry, and the affected skin area was 3%10% of body surface area (estimated by palm method); the diameter of target lesionswas 210cm and located in the limbs or trunk.

  • The course of chronic eczema is more than 6 months;

  • Age 18 to 70, males or females;

  • The Subjects obtain informed consent, participated the trial voluntarily. Procedure toobtain informed consent is in accordance with the provisions of Good ClinicalPractise(GCP).

Exclusion

Exclusion Criteria:

  • Subjects with acute eczema, subacute eczema, universal eczema, special type of eczema;

  • Subjects used corticosteroids, immunosuppressive agents and ultraviolet irradiation in 4 weeks prior to the enrollment;

  • Subjects were treated with antihistamine and topical drugs in 2 weeks;

  • Women in Pregnancy, Lactation, or Planned pregnancy during the test;

  • Comorbid with severe primary heart, liver, lung, kidney, blood disease, diabetes,thyroid disease or a serious disease affecting survival, such as cancer or HIV / AIDS;

  • Subjects were allergic to test drug ingredients;

  • Subjects could not give full informed consent because of mental and behavioraldisorders;

  • Suspected or identified with a history of alcohol or drug abuse;

  • Have other diseases or conditions which may reduce the possibility of enrollment orcomplicate the recruiting process based on the investigator judgment. For example,working environment changed frequently led to easily lost follow-up;

  • Have been or currently enrolled in other clinical trials within 3 months.

Study Design

Total Participants: 240
Study Start date:
March 01, 2016
Estimated Completion Date:
February 28, 2017

Study Description

Polygoni multiflori Preparata, dried rehmannia root, mulberry leaf, sophora flavescens, Honghuoma, for skin itching, acne, constipation due to blood vacuity and wind-dryness, also used in clinical treatment of eczema.

The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Active - Recruiting

  • Beijing Friendship Hospital,Capital Medical University

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqin Medical University

    Chongqing, Chongqing 400016
    China

    Active - Recruiting

  • Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Dermotology hospital, Chinese academy of medical science

    Nanjing, Jiangsu 210042
    China

    Active - Recruiting

  • Dermatology Hospital in Shandong Province

    Ji nan, Shandong 250022
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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