Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

Guizhou Tongjitang Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Chronic Eczema

Treatments: Drug: Runzaozhiyang capsule agent simulation; Drug: Urea cream; Drug: Runzao zhiyang capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02601222

Z-RZZY-JN-RS

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

Runzao zhiyang capsule

Experimental group

Description:

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.

Treatment:

Drug: Urea cream

Drug: Runzao zhiyang capsule

Runzaozhiyang capsule agent simulation

Placebo Comparator group

Description:

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.

Treatment:

Drug: Urea cream

Drug: Runzaozhiyang capsule agent simulation