A clinical study of Hwangryunhaedoktang in adult atopic dermatitis

ISRCTN	ISRCTN26218532
DOI	https://doi.org/10.1186/ISRCTN26218532
Secondary identifying numbers	B090016-1012-0000100

Submission date: 12/07/2010
Registration date: 29/07/2010
Last edited: 03/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Namkwen Kim
Scientific

Wonkwang University Oriental Medical Center
1126-1 Sanbon-dong
Gunpo
435-040
Korea, South

Email	drkim@wonkwang.ac.kr

Study information

Study design	Randomised phase III double blind two arm placebo controlled multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	A clinical study of Hwangryunhaedoktang in adult atopic dermatitis : a randomised, double-blind, placebo-controlled, multicentre trial
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	21/06/2010
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	21/06/2010
Date of final enrolment	30/04/2011

Locations

Countries of recruitment

Korea, South

Study participating centre

Wonkwang University Oriental Medical Center

Gunpo
435-040
Korea, South

Sponsor information

Korea Health Industry Development Institute (KHIDI)
Research organisation

57-1 Noryangjin-dong Dongjak-gu
Seoul
158-800
Korea, South

Email	withingrace@khidi.or.kr
Website	http://eng.khidi.or.kr/
"ROR"	https://ror.org/00fdzyk40

Funders

Funder type

Research organisation

Korea Health Industry Development Institute (KHIDI) (South Korea) - The Traditional Korean Medicine Research and Development Project

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/08/2011		Yes	No