Back to resultsEstablishing the Collaborative Care Model of Traditional Chinese Medicine and Western Medicine-Pediatric Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
TCM
Western medicine
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility 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
Sites / Locations
- China Medical University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Collaborative Care of TCM and Western Medicine
Western Medicine
Arm Description
Outcomes
Primary Outcome Measures
Scoring Atopic Dermatitis (SCORAD) score
a clinical tool to assess the extent and severity of eczema
Secondary Outcome Measures
36-Item Short Form Health Survey (SF-36)
It is a 36-item, patient-reported survey of patient health.
Full Information
NCT ID
NCT03375970
First Posted
May 26, 2017
Last Updated
December 15, 2017
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03375970
Brief Title
Establishing the Collaborative Care Model of Traditional Chinese Medicine and Western Medicine-Pediatric Atopic Dermatitis
Official Title
Establishing the Collaborative Care Model of TCM and Western Medicine-Pediatric Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collaborative Care of TCM and Western Medicine
Arm Type
Experimental
Arm Title
Western Medicine
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
TCM
Intervention Description
oral chinese herb, chinese topical ointment
Intervention Type
Other
Intervention Name(s)
Western medicine
Intervention Description
oral steroid, oral antihistamine, topical steroid
Primary Outcome Measure Information:
Title
Scoring Atopic Dermatitis (SCORAD) score
Description
a clinical tool to assess the extent and severity of eczema
Time Frame
week 4
Secondary Outcome Measure Information:
Title
36-Item Short Form Health Survey (SF-36)
Description
It is a 36-item, patient-reported survey of patient health.
Time Frame
week 4
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Rong Yen
Phone
+886975681439
Email
hungrongyen@gmail.com
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen
Phone
+886975681439
Email
hungrongyen@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Establishing the Collaborative Care Model of Traditional Chinese Medicine and Western Medicine-Pediatric Atopic Dermatitis
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