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Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

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ClinicalTrials.gov Identifier: NCT02601222
Recruitment Status : Unknown
Verified September 2016 by Guizhou Tongjitang Pharmaceutical Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : November 10, 2015
Last Update Posted : September 20, 2016
Sponsor:
Collaborator:
Beijing Bionovo Medicine Development Co., Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Eczema Drug: Runzao zhiyang capsule Drug: Runzaozhiyang capsule agent simulation Drug: Urea cream Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 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.
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.

Drug: 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.

Placebo Comparator: 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.
Drug: 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.

Drug: 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.




Primary Outcome Measures :
  1. 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% [ Time Frame: 0,4 weeks ]

Secondary Outcome Measures :
  1. The decrease rate of EASI in each visit compare with baseline [ Time Frame: 0,2,4,8,12 weeks ]
  2. Changes in the degree of pruritus(test by visual analogue scale) in the follow-up visits compared with baseline [ Time Frame: 0,2,4,8,12 weeks ]
  3. DLQI (Dermatology Life Quality Index) score changes during the follow-up visits compared with baseline. [ Time Frame: 0,2,4,8,12 weeks ]
  4. The proportion of patients (EASI score greater than 10% of the patients before treatment) [ Time Frame: 8,12 weeks ]
  5. EASI score [ Time Frame: 8,12 weeks ]

Other Outcome Measures:
  1. Safety assessments will be based on adverse event reports. [ Time Frame: 2,4,8,12 weeks ]
  2. Safety assessments will be based on electrocardiogram, physical examinations, and clinical laboratory tests. [ Time Frame: 0,2,4,8,12 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601222


Contacts
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Contact: Gu heng, M.D. +86-25-85478045

Locations
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China, Anhui
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China, 230022
Contact: Yang Sen, M.D.    +86-551-62922016      
China, Beijing
Beijing Friendship Hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Li Linfeng, M.D.    +86-10-63138628      
China, Chongqing
The First Affiliated Hospital of Chongqin Medical University Recruiting
Chongqing, Chongqing, China, 400016
Contact: Li Hui, M.D.    +86-25-85478045      
China, Guangdong
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Zeng Fanqin, M.D.    +86-20-81332371      
China, Hunan
The Second Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410011
Contact: Lu Qianjin, M.D.    0731-85292097      
China, Jiangsu
Dermotology hospital, Chinese academy of medical science Recruiting
Nanjing, Jiangsu, China, 210042
Contact: Gu Heng, M.D.    025-85478045      
China, Shandong
Dermatology Hospital in Shandong Province Recruiting
Ji nan, Shandong, China, 250022
Contact: Zhang Furen, M.D.    +86-531-87298884      
China, Shanghai
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Zhen Jie, M.D.    +86-21-54661789      
Huashan Hospital, Fudan University Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Xu Jinhua, M.D.    +86-21-52888045      
Sponsors and Collaborators
Guizhou Tongjitang Pharmaceutical Co.,Ltd
Beijing Bionovo Medicine Development Co., Ltd.
Investigators
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Principal Investigator: Gu heng, M.D. Dermotology hospital, Chinese academy of medical science

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Responsible Party: Guizhou Tongjitang Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT02601222     History of Changes
Other Study ID Numbers: Z-RZZY-JN-RS
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by Guizhou Tongjitang Pharmaceutical Co.,Ltd:
chronic eczema
efficacy and safety
Runzao zhiyang capsule

Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous