Clinical Trial: Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.
Detailed Summary:
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.
Sponsor: Guizhou Tongjitang Pharmaceutical Co.,Ltd
Current Primary Outcome: 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% [ Time Frame: 0,4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The decrease rate of EASI in each visit compare with baseline [ Time Frame: 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 [ Time Frame: 0,2,4,8,12 weeks ]
- DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline. [ Time Frame: 0,2,4,8,12 weeks ]
- The proportion of patients (EASI score greater than 10% of the patients before treatment) [ Time Frame: 8,12 weeks ]
- EASI score [ Time Frame: 8,12 weeks ]
Original Secondary Outcome: Same as current
Information By: Guizhou Tongjitang Pharmaceutical Co.,Ltd
Dates:
Date Received: October 9, 2015
Date Started: March 2016
Date Completion: February 2017
Last Updated: September 19, 2016
Last Verified: September 2016
