NCT03375970

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
Last Updated

December 18, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

May 26, 2017

Last Update Submit

December 15, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Scoring Atopic Dermatitis (SCORAD) score

    a clinical tool to assess the extent and severity of eczema

    week 4

Secondary Outcomes (1)

  • 36-Item Short Form Health Survey (SF-36)

    week 4

Study Arms (2)

Collaborative Care of TCM and Western Medicine

EXPERIMENTAL
Other: TCMOther: Western medicine

Western Medicine

ACTIVE COMPARATOR
Other: Western medicine

Interventions

TCMOTHER

oral chinese herb, chinese topical ointment

Collaborative Care of TCM and Western Medicine

oral steroid, oral antihistamine, topical steroid

Collaborative Care of TCM and Western MedicineWestern Medicine

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

May 26, 2017

First Posted

December 18, 2017

Study Start

May 2, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 18, 2017

Record last verified: 2017-04

Locations