Contact information
Type
Scientific
Primary contact
Dr Namkwen Kim
ORCID ID
Contact details
Wonkwang University Oriental Medical Center
1126-1 Sanbon-dong
Gunpo
435-040
Korea
South
drkim@wonkwang.ac.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
B090016-1012-0000100
Study information
Scientific title
A clinical study of Hwangryunhaedoktang in adult atopic dermatitis : a randomised, double-blind, placebo-controlled, multicentre trial
Acronym
Study hypothesis
This study is aimed at proving the efficacy, safety and economic evaluation of Hwangryunhaedoktang, with a view to extend the insurance coverage for adult atopic dermatitis patients.
Ethics approval
1. Wonkwang University Oriental Medical Centre Ethics Committee approved on the 3rd May 2010
2. Sangji University Oriental Medical Centre Ethics Committee approved on the 18th May 2010
3. Wonkwang University Medical Centre Ethics Committee approved on the 18th June 2010
Study design
Randomised phase III double blind two arm placebo controlled multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Atopic dermatitis - adult type
Intervention
This is a randomised, double-blind, placebo-controlled, multi-centre trial study. Participants will receive hwangryunhaedoktang or a placebo-drug for 8 weeks. Oral administration occurs according to the following statements:
1. Patients in group 1 receive hwangryunhaedoktang and instructions on how to make a tea; they take a packet of the medicine (5.00g) with tepid water for three times a day after meal
2. Patients in group 2 receive the placebo medicine (powdered extract) used in the same way as with group 1
The total duration of all arms is 11 weeks. Timepoints are as follows:
Visit 1: screening
Visit 2: treatment initiation, participants will receive hwangryunhaedoktang or a placebo-drug for 8 weeks.
Visit 3: 2 weeks later of first medication, follow-up
Visit 4: 4 weeks later of first medication, follow-up
Visit 5: 8 weeks later of first medication, follow-up and treatment finish
Post-treatment follow-up will be performed 2 weeks post-intervention. (by phone-call)
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
1. Efficacy:
SCORing Atopic Dermatitis index (SCORAD): the purpose of this questionnaire is to identify the lesional, symptomatic, subjective severities. Measured at treatment period (treatment initiation, 2․4․8 weeks later of first medication)
2. Safety:
2.1. Complete Blood Cell Cound (CBC)
2.2. Erythrocyte Sedimentation Rate (ESR)
2.3. Blood chemistry
2.4. Urine analysis
2.5. Chest-PA film
Measured at baseline, 8 weeks after first medication
2.6. Vital signs, measured at baseline, treatment period (treatment initiation, 2, 4, 8 weeks after first medication)
Secondary outcome measures
Efficacy:
1. Total IgE
2. Eosinophil count
Measured at treatment initiation, 4 and 8 weeks after first medication
3. EuroQol 5-Dimension (EQ-5D)
4. Health Utilities Index Mark 3 (HUI-3)
5. Dermatology Life Quality Index (DLQI)
Measured at treatment initiation, 8 weeks after first medication
Overall trial start date
21/06/2010
Overall trial end date
30/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age greater than 19 years, either sex
2. Typical conditions of intermittent or continuous atopic eczema
2.1. Duration of more than 6 months
2.2. Satisfied Hanifin and Rajkas criteria for atopic dermatitis
3. Diagnosed with adult atopic dermatitis by two different oriental medicine doctors
4. Written and informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Other dermatitis or systemic disease except for atopic eczema
2. Administration of steroids and immunosuppressant per os (by mouth) within one week from the interview (topical application not relevant)
3. Women who are pregnant, lactating or without contraception
4. Clinical severe hepatic disease or abnormal liver function tests at least twice the upper limit of normal
5. Other clinical trial within the last 1 month
6. Hypersensitivity or allergy of drugs
7. Disease which can affect the absorption of drugs or disordered digestion after surgery related to the disease
8. Cannot understand written consent or follow this study:
8.1. Mental retardation
8.2. Mental or emotional problems
9. Judged by expert as inappropriate to participate in this study
Recruitment start date
21/06/2010
Recruitment end date
30/04/2011
Locations
Countries of recruitment
Korea, South
Trial participating centre
Wonkwang University Oriental Medical Center
Gunpo
435-040
Korea, South
Sponsor information
Organisation
Korea Health Industry Development Institute (KHIDI)
Sponsor details
57-1 Noryangjin-dong Dongjak-gu
Seoul
158-800
Korea
South
withingrace@khidi.or.kr
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Korea Health Industry Development Institute (KHIDI) (South Korea) - The Traditional Korean Medicine Research and Development Project
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21861896
Publication citations
-
Results
Kim NK, Lee DH, Seo HS, Sun SH, Oh YL, Kim JE, Yoon IH, Seo ES, Shim GS, Zaslawski C, Hwangryunhaedoktang in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, two-centre trial--study protocol., BMC Complement Altern Med, 2011, 11, 68, doi: 10.1186/1472-6882-11-68.