Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

Chronic Eczema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02601222
• Other study ID #: Z-RZZY-JN-RS
• Status: Recruiting
• Phase: Phase 4
• First received: October 9, 2015
• Last updated: September 19, 2016
• Start date: March 2016
• Est. completion date: February 2017

Study information

• Verified date: September 2016
• Source: Guizhou Tongjitang Pharmaceutical Co.,Ltd
• Contact: Gu heng, M.D.
• Phone: +86-25-85478045
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Eczema
• Eczema

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The First Affiliated Hospital of Chongqin Medical University	Chongqing	Chongqing
China	Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Dermatology Hospital in Shandong Province	Ji nan	Shandong
China	Dermotology hospital, Chinese academy of medical science	Nanjing	Jiangsu
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Guizhou Tongjitang Pharmaceutical Co.,Ltd	Beijing Bionovo Medicine Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety assessments will be based on adverse event reports.		2,4,8,12 weeks	Yes
Other	Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests.		0,2,4,8,12 weeks	Yes
Primary	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	No
Secondary	The decrease rate of EASI in each visit compare with baseline		0,2,4,8,12 weeks	No
Secondary	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	No
Secondary	DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline.		0,2,4,8,12 weeks	No
Secondary	The proportion of patients (EASI score greater than 10% of the patients before treatment)		8,12 weeks	No
Secondary	EASI score		8,12 weeks	No