Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trials to Evaluate the Efficacy and Safety of Runzao Zhiyang Capsule in Treating Chronic Eczema

The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.

Study Overview

• Status: Unknown
• Conditions: Chronic Eczema
• Intervention / Treatment: Drug: Runzao zhiyang capsule; Drug: Urea cream; Drug: Runzaozhiyang capsule agent simulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Yang Sen, M.D.; Phone Number: +86-551-62922016
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital,Capital Medical University
      • Contact: Li Linfeng, M.D.; Phone Number: +86-10-63138628
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Recruiting
      • The First Affiliated Hospital of Chongqin Medical University
      • Contact: Li Hui, M.D.; Phone Number: +86-25-85478045
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-sen Memorial Hospital,Sun Yat-sen University
      • Contact: Zeng Fanqin, M.D.; Phone Number: +86-20-81332371
  • Hunan
    • Changsha, Hunan, China, 410011
      • Not yet recruiting
      • The Second Xiangya Hospital of Central South University
      • Contact: Lu Qianjin, M.D.; Phone Number: 0731-85292097
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Recruiting
      • Dermotology hospital, Chinese academy of medical science
      • Contact: Gu Heng, M.D.; Phone Number: 025-85478045
  • Shandong
    • Ji nan, Shandong, China, 250022
      • Recruiting
      • Dermatology Hospital in Shandong Province
      • Contact: Zhang Furen, M.D.; Phone Number: +86-531-87298884
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
      • Contact: Zhen Jie, M.D.; Phone Number: +86-21-54661789
    • Shanghai, Shanghai, China, 200040
      • Not yet recruiting
      • Huashan Hospital, Fudan University
      • Contact: Xu Jinhua, M.D.; Phone Number: +86-21-52888045

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Drug: 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.
Placebo Comparator: 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.	Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Guizhou Tongjitang Pharmaceutical Co.,Ltd
• Collaborators: Beijing Bionovo Medicine Development Co., Ltd.
• Investigators: Principal Investigator: Gu heng, M.D., Dermotology hospital, Chinese academy of medical science

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: October 9, 2015
• First Submitted That Met QC Criteria: November 8, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: efficacy and safety; chronic eczema; Runzao zhiyang capsule
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: Z-RZZY-JN-RS