- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03375970
Establishing the Collaborative Care Model of Traditional Chinese Medicine and Western Medicine-Pediatric Atopic Dermatitis
December 15, 2017 updated by: Hung-Rong Yen, China Medical University Hospital
Establishing the Collaborative Care Model of TCM and Western Medicine-Pediatric Atopic Dermatitis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Taichung, Taiwan, 404
- Recruiting
- China Medical University Hospital
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Contact:
- Hung-Rong Yen
- Phone Number: +886975681439
- Email: hungrongyen@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Collaborative Care of TCM and Western Medicine
|
oral chinese herb, chinese topical ointment
oral steroid, oral antihistamine, topical steroid
|
|
ACTIVE_COMPARATOR: Western Medicine
|
oral steroid, oral antihistamine, topical steroid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scoring Atopic Dermatitis (SCORAD) score
Time Frame: week 4
|
a clinical tool to assess the extent and severity of eczema
|
week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
36-Item Short Form Health Survey (SF-36)
Time Frame: week 4
|
It is a 36-item, patient-reported survey of patient health.
|
week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 2, 2017
Primary Completion (ANTICIPATED)
December 1, 2017
Study Completion (ANTICIPATED)
December 1, 2017
Study Registration Dates
First Submitted
May 26, 2017
First Submitted That Met QC Criteria
December 15, 2017
First Posted (ACTUAL)
December 18, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 18, 2017
Last Update Submitted That Met QC Criteria
December 15, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH106-REC2-029
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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