Condition category
Skin and Connective Tissue Diseases
Date applied
12/07/2010
Date assigned
29/07/2010
Last edited
03/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 Rajka’s 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

http://eng.khidi.or.kr/

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21861896

Publication citations

  1. 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.

Additional files

Editorial Notes