The Chinese University of Hong Kong
Hong Kong
Location status: Recruiting
Location contact
Zhi-xiu Lin, PhD
CONTACT
NCT Number: NCT04419584
The study aims to evaluate the clinical efficacy and safety of the modified Qing-Ying Decoction (mQYD) for the treatment of subacute and chronic atopic dermatitis (AD) in children when compared to the placebo control through examining the clinical symptoms, quality of life, gut microbiome, and Chinese medicine body constitution.
This is a parallel, randomized, placebo-controlled, double-blind clinical trial. Eligible subjects will be randomly allocated to receive oral mQYD granules or it's placebo granules. Subjects will have 12-week of treatment, and then a 4-week follow-up.
Interested in participating?
Request Info4 year–17 year
All sexes
Interventional
Phase 2 / Phase 3
Hong Kong
Location status: Recruiting
Zhi-xiu Lin, PhD
CONTACT
The subjects will come for a screening visit at week 0 (baseline), then at week 6, week 12, and week 16 for Chinese medicine practitioner (CMP) investigators assessments. Eczema Area and Severity Index (EASI), Children's Dermatology Life Quality Index (CDLQI), Patient-Oriented Eczema Measure (POEM), and Chinese Medicine body constitution types will be assessed and filled up at different timepoints. They will receive oral herbal mQYD or placebo granules for 12 weeks and then be followed up 4 weeks after the treatment. Registered CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit. Besides, they need to record the food taken in a diary before the day for taking faecal specimen for gut microbiome analysis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Herbal granules
Placebo granules
Time frame: 16 weeks
Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis
Time frame: 16 weeks
Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.
Time frame: 16 weeks
Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.
Time frame: 16 weeks
Not a scale. Based on the answers, a logarithm will be used to determine the type of Chinese Medicine Constitution of the subjects. To assess the Chinese medicine body constitution of subjects.
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
A Randomized Placebo-Controlled Clinical Trial of an Innovative Herbal Formula for Atopic Dermatitis in Children: Evaluations of Modified Qing-Ying Decoction on Efficacy and Gut Microbiome
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07262983
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Bethesda, Maryland, United States
View Trial DetailsNCT07467564
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Doha, Qatar
View Trial DetailsNCT07216027
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Northridge, California, United States
View Trial DetailsNCT04864886
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Bethesda, Maryland, United States
View Trial Details