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| Name | Class |
|---|---|
| Beijing Bionovo Medicine Development Co., Ltd. | OTHER |
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The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Runzao zhiyang capsule | Experimental | 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. |
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| Runzaozhiyang capsule agent simulation | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Runzao zhiyang capsule | Drug | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments will be based on adverse event reports. | 2,4,8,12 weeks | |
| Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests. | 0,2,4,8,12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gu heng, M.D. | Contact | +86-25-85478045 |
| Name | Affiliation | Role |
|---|---|---|
| Gu heng, M.D. | Dermotology hospital, Chinese academy of medical science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230022 | China |
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| Runzaozhiyang capsule agent simulation | Drug | 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. |
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| Urea cream | Drug | 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. |
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| 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 |
| Beijing Friendship Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| The First Affiliated Hospital of Chongqin Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
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| Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
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| Dermotology hospital, Chinese academy of medical science | Recruiting | Nanjing | Jiangsu | 210042 | China |
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| Dermatology Hospital in Shandong Province | Recruiting | Jinan | Shandong | 250022 | China |
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| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Huashan Hospital, Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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