Chronic Eczema
Conditions
Keywords
chronic eczema, efficacy and safety, Runzao zhiyang capsule
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.
Interventions
DRUGRunzao 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.
DRUGRunzaozhiyang 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.
DRUGUrea 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.
Sponsors
Beijing Bionovo Medicine Development Co., Ltd.
Guizhou Tongjitang Pharmaceutical Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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
| 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 |
Countries
China
Contacts
Primary ContactGu heng, M.D.
Outcome results
None listed