Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Eczema

Intervention / Treatment
-----------------
* Drug: Runzao zhiyang capsule
* Drug: Runzaozhiyang capsule agent simulation
* Drug: Urea cream


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Runzao zhiyang capsule<br>Runzao zhiyang capsule: 4 pills each time, 3 times a day, oral， Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day. | Drug: Runzao zhiyang capsule<br>* Runzao zhiyang capsule：4 pills each time, 3 times a day, oral. Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.<br>Drug: Urea cream<br>* Topical application, apply to the affected area and gently rub, 2 times a day.Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.<br>|
| Placebo Comparator: Runzaozhiyang capsule agent simulation<br>Runzaozhiyang capsule agent simulation:4 pills each time, 3 times a day, oral, Urea Cream (topical application, apply to the affected area and gently rub) 2 times a day. | Drug: Runzaozhiyang capsule agent simulation<br>* Runzaozhiyang capsule agent simulation：4 pills each time, 3 times a day, oral， Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.<br>Drug: Urea cream<br>* Topical application, apply to the affected area and gently rub, 2 times a day.Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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% |  | 0,4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease rate of EASI in each visit compare with baseline |  | 0,2,4,8,12 weeks | 
| Changes in the degree of pruritus（test by visual analogue scale） in the follow-up visits compared with baseline |  | 0,2,4,8,12 weeks | 
| DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline. |  | 0,2,4,8,12 weeks | 
| The proportion of patients (EASI score greater than 10% of the patients before treatment) |  | 8,12 weeks | 
| EASI score |  | 8,12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic eczema, efficacy and safety, Runzao zhiyang capsule