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Status unknownNCT03375970Updated Dec 18, 2017

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

An interventional study of TCM and Western medicine in Atopic Dermatitis, sponsored by China Medical University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-12-18.

Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Collaborative Care of TCM and Western Medicine

    Other: TCM · Other: Western medicine

  • Active comparator
    Western Medicine

    Other: Western medicine

Interventions

  • OtherTCM

    oral chinese herb, chinese topical ointment

  • OtherWestern medicine

    oral steroid, oral antihistamine, topical steroid

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What researchers measure

Primary outcomes

  1. Scoring Atopic Dermatitis (SCORAD) score

    a clinical tool to assess the extent and severity of eczema

    Time frame: week 4

Secondary outcomes

  1. 36-Item Short Form Health Survey (SF-36)

    It is a 36-item, patient-reported survey of patient health.

    Time frame: week 4

07

Study locations

1 of 1 sites recruiting
  • China Medical University Hospital
    Taichung, 404, Taiwan
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2017 (actual). Primary completion is estimated for Dec 2017, 7 months after the start.

Of 102 non-industry interventional studies with no phase under Dermatitis, Atopic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 7 months is below that.

Counting every sponsor, half of 163 studies reached it within 16 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
May 26, 2017
First posted
Dec 18, 2017
StartActual
May 2, 2017
Primary completionEst.
Dec 2017
CompletionEst.
Dec 2017
Last update
Dec 18, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03375970
Responsible party
Hung-Rong Yen (Attending physician, China Medical University Hospital) — Principal investigator
First posted
Dec 18, 2017
Start date
May 2, 2017
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Dec 18, 2017

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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