Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

• Status: Unknown status
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.