Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema
NCT ID: NCT02601222
Last Updated: 2016-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2016-03-31
2017-02-28
Brief Summary
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Detailed Description
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The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Runzao zhiyang capsule
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.
Runzao zhiyang capsule
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.
Urea cream
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.
Runzaozhiyang capsule agent simulation
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.
Runzaozhiyang capsule agent simulation
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.
Urea cream
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.
Interventions
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Runzao zhiyang capsule
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.
Runzaozhiyang capsule agent simulation
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.
Urea cream
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Beijing Bionovo Medicine Development Co., Ltd.
OTHER
Guizhou Tongjitang Pharmaceutical Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Gu heng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Dermotology hospital, Chinese academy of medical science
Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqin Medical University
Chongqing, Chongqing Municipality, China
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Dermotology hospital, Chinese academy of medical science
Nanjing, Jiangsu, China
Dermatology Hospital in Shandong Province
Jinan, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Gu heng, M.D.
Role: CONTACT
Facility Contacts
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Yang Sen, M.D.
Role: primary
Li Linfeng, M.D.
Role: primary
Li Hui, M.D.
Role: primary
Zeng Fanqin, M.D.
Role: primary
Lu Qianjin, M.D.
Role: primary
Gu Heng, M.D.
Role: primary
Zhang Furen, M.D.
Role: primary
Zhen Jie, M.D.
Role: primary
Xu Jinhua, M.D.
Role: primary
Other Identifiers
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Z-RZZY-JN-RS
Identifier Type: -
Identifier Source: org_study_id
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