Clinical trial NCT02601222: Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trials to Evaluate the Efficacy and Safety of Runzao Zhiyang Capsule in Treating Chronic Eczema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Eczema
Keywords: chronic eczema
efficacy and safety
Runzao zhiyang capsule
Lead sponsor: Guizhou Tongjitang Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Bionovo Medicine Development Co., Ltd.
First posted: 2015-11-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Consistent with diagnostic criteria for chronic eczema(Referring to "the Chinese eczema 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 lesions was 2\~10cm 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 to obtain informed consent is in accordance with the provisions of Good Clinical Practise(GCP).

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 behavioral disorders;
* Suspected or identified with a history of alcohol or drug abuse;
* Have other diseases or conditions which may reduce the possibility of enrollment or complicate 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.

Primary outcomes:
measure: The efficiency(The number of cured cases and cases with marked effect) of disease： Using EASI score decline rate to judge. The decline rate of EASI = (before treatment EASI- After treatment EASI)/ before treatment EASI×100%
timeFrame: 0,4 weeks
Secondary outcomes:
measure: The decrease rate of EASI in each visit compare with baseline
timeFrame: 0,2,4,8,12 weeks
measure: Changes in the degree of pruritus（test by visual analogue scale） in the follow-up visits compared with baseline
timeFrame: 0,2,4,8,12 weeks
measure: DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline.
timeFrame: 0,2,4,8,12 weeks
measure: The proportion of patients (EASI score greater than 10% of the patients before treatment)
timeFrame: 8,12 weeks
measure: EASI score
timeFrame: 8,12 weeks
Other outcomes:
measure: Safety assessments will be based on adverse event reports.
timeFrame: 2,4,8,12 weeks
measure: Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests.
timeFrame: 0,2,4，8，12 weeks
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqin Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Dermotology hospital, Chinese academy of medical science
state: Jiangsu
city: Ji nan
country: China
facility: Dermatology Hospital in Shandong Province
state: Shandong
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Dermotology hospital, Chinese academy of medical science
name: Gu heng, M.D.
role: PRINCIPAL_INVESTIGATOR
References: