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11 February 2012
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| [ Print-friendly version ] |
| A clinical study of Hwangryunhaedoktang in adult atopic dermatitis |
| ISRCTN | ISRCTN26218532 |
| ClinicalTrials.gov identifier | |
| Public title | A clinical study of Hwangryunhaedoktang in adult atopic dermatitis |
| Scientific title | A clinical study of Hwangryunhaedoktang in adult atopic dermatitis : a randomised, double-blind, placebo-controlled, multicentre trial |
| Acronym | N/A |
| Serial number at source | B090016-1012-0000100 |
| 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. |
| Lay summary | Not provided at time of registration |
| 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 |
| Countries of recruitment | Korea, South |
| Disease/condition/study domain | Atopic dermatitis - adult type |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 21/06/2010 |
| Anticipated end date | 30/04/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions |
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) |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Korea Health Industry Development Institute (KHIDI) (South Korea) - The Traditional Korean Medicine Research and Development Project |
| Trial website | |
| Publications | 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21861896 |
| Contact name | Dr Namkwen Kim |
| Address |
Wonkwang University Oriental Medical Center
1126-1 Sanbon-dong |
| City/town | Gunpo |
| Zip/Postcode | 435-040 |
| Country | Korea, South |
| drkim@wonkwang.ac.kr | |
| Sponsor | Korea Health Industry Development Institute (KHIDI) |
| Address | 57-1 Noryangjin-dong Dongjak-gu |
| City/town | Seoul |
| Zip/Postcode | 158-800 |
| Country | Korea, South |
| withingrace@khidi.or.kr | |
| Sponsor website: | http://eng.khidi.or.kr/ |
| Date applied | 12/07/2010 |
| Last edited | 03/01/2012 |
| Date ISRCTN assigned | 29/07/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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