Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

Phase 4

• Conditions: Chronic Eczema
• Interventions: Drug: Runzaozhiyang capsule agent simulation; Drug: Runzao zhiyang capsule; Drug: Urea cream

• Registration Number: NCT02601222
• Lead Sponsor: Guizhou Tongjitang Pharmaceutical Co.,Ltd

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-11-08
• Study First Posted: 2015-11-10
• Study Start: 2016-03
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20
• Primary Completion: 2016-12
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Runzao zhiyang capsule	Urea cream	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	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.
Runzao zhiyang capsule	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.
Runzaozhiyang capsule agent simulation	Urea cream	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (9)

Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Friendship Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Dermotology hospital, Chinese academy of medical science; 🇨🇳 Nanjing, Jiangsu, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Chongqin Medical University; 🇨🇳 Chongqing, Chongqing, China

Dermatology Hospital in Shandong Province; 🇨🇳 Ji nan, Shandong, China