A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trials to Evaluate the Efficacy and Safety of Runzao Zhiyang Capsule in Treating Chronic Eczema
Sponsor study identifier
interventional
240
1 country
9
Study Start
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2015
Actual (reported)November 10, 2015
Actual (reported)March 2016
Date type not reportedThis date has not been verified as actual or estimated.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
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.
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.
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：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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050, China
Gu heng, M.D.
Dermotology hospital, Chinese academy of medical science
First Submitted
October 9, 2015
First Posted
November 10, 2015
Study Start
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
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.
Contact the study team to confirm eligibility.
The First Affiliated Hospital of Chongqin Medical University
Chongqing, Chongqing Municipality, 400016, China
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Dermotology hospital, Chinese academy of medical science
Nanjing, Jiangsu, 210042, China
Dermatology Hospital in Shandong Province
Jinan, Shandong, 250022, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 20, 2016
Record last verified: 2016-09
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