Atopic DermatitisNCT03375970
Establishing the Collaborative Care Model of Traditional Chinese Medicine and Western Medicine-Pediatric Atopic Dermatitis
A study testing TCM and Western medicine in people with Atopic Dermatitis, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- TCM and Western medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 May 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 0-18
- meets the Hanifin and Rajka diagnostic criteria
- SCORAD score ≧ 25
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Hung-Rong Yen, +886975681439, hungrongyen@gmail.com
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis
- Being tested
- TCM, Western medicine
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCMOther
oral chinese herb, chinese topical ointment
Western medicineOther
oral steroid, oral antihistamine, topical steroid
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care of TCM and Western Medicine | Experimental | Not described Receives: Other: TCM; Other: Western medicine |
| Western Medicine | Active comparator | Not described Receives: Other: Western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring Atopic Dermatitis (SCORAD) score
a clinical tool to assess the extent and severity of eczema
Measured: week 4
Secondary outcomes (1)
36-Item Short Form Health Survey (SF-36)
It is a 36-item, patient-reported survey of patient health.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start2 May 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Rong Yen, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375970
- Sponsor's protocol ID
- CMUH106-REC2-029
- Status last verified
- Apr 2017
- First submitted
- 26 May 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Collaborative Care Model of TCM and Western Medicine-Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03375970
- Acronym / sponsor ID
- CMUH106-REC2-029
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care of TCM and Western Medicine | Experimental | Other: TCM, Other: Western medicine |
| Western Medicine | Active comparator | Other: Western medicine |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 0-18
- meets the Hanifin and Rajka diagnostic criteria
- SCORAD score ≧ 25
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCMoral chinese herb, chinese topical ointment | Other | Collaborative Care of TCM and Western Medicine |
| Western medicineoral steroid, oral antihistamine, topical steroid | Other | Collaborative Care of TCM and Western Medicine, Western Medicine |
Primary outcome
Scoring Atopic Dermatitis (SCORAD) score
Time frame: week 4
a clinical tool to assess the extent and severity of eczema
1 secondary outcome
36-Item Short Form Health Survey (SF-36)
Time frame: week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCM and Western medicine in people with Atopic Dermatitis, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Rong Yen (+886975681439, hungrongyen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoring Atopic Dermatitis (SCORAD) score (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.