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Trial record 5 of 3030 for:    China Medicine University Hospital

Establishing the Collaborative Care Model of Traditional Chinese Medicine and Western Medicine-Pediatric Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03375970
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Hung-Rong Yen, China Medical University Hospital

Brief Summary:
In Taiwan, there are many patients suffer from pediatric atopic dermatitis. Because of the clinical characteristic of repetitive and scratchy, which will affect the patients' quality of life and lead to the medical heavy budget. TCM may play an important role in this disease and help patient to improved their health. In this project, we aim to establish a Collaborative Care Model of TCM and Western Medicine, to achieve the multiple goal in clinical treatment, research and medical training. By establishing a collaborative care model, including the Chinese medicine doctor and Western medicine doctor, nurses, pharmacists and case managers, to cooperative satisfy the patient needed in the medical service, to improve the clinical presentation, patients'quality of life, and reduce exposure to corticosteroid. Besides, we can also build a training environment and reduce medical cost in long term purpose. Furthermore, by establishing a collaborative care model, we can provide a medical education and training opportunity to educate the medical student and clinician the necessary knowledge of pediatric atopic dermatitis by caring patients and learning from clinical case. According to the above training program, we not only aim to strengthen the competitiveness of Chinese medicine doctor in Taiwan, but also make the Western medicine doctors comprehend the TCM characteristic and may find out the even more opportunity to cooperate in clinical practice. To make this collaborative care model as a beginning milestone of cooperation between Chinese medicine and Western medicine.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: TCM Other: Western medicine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Establishing the Collaborative Care Model of TCM and Western Medicine-Pediatric Atopic Dermatitis
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Collaborative Care of TCM and Western Medicine Other: TCM
oral chinese herb, chinese topical ointment

Other: Western medicine
oral steroid, oral antihistamine, topical steroid

Active Comparator: Western Medicine Other: Western medicine
oral steroid, oral antihistamine, topical steroid




Primary Outcome Measures :
  1. Scoring Atopic Dermatitis (SCORAD) score [ Time Frame: week 4 ]
    a clinical tool to assess the extent and severity of eczema


Secondary Outcome Measures :
  1. 36-Item Short Form Health Survey (SF-36) [ Time Frame: week 4 ]
    It is a 36-item, patient-reported survey of patient health.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 0-18
  • meets the Hanifin and Rajka diagnostic criteria
  • SCORAD score ≧ 25

Exclusion Criteria:

  • Drug abuse
  • Pregnent or lactating women
  • Mental or behavioral abnormalities
  • Allergic to the ingredients of the test regimen
  • Any potentially life-threatening disease or dysfunctional organ system l

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): NCT03375970


Contacts
Contact: Hung-Rong Yen +886975681439 hungrongyen@gmail.com

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Hung-Rong Yen    +886975681439    hungrongyen@gmail.com   
Sponsors and Collaborators
China Medical University Hospital

Responsible Party: Hung-Rong Yen, Attending physician, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03375970     History of Changes
Other Study ID Numbers: CMUH106-REC2-029
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases