Atopic DermatitisPhase 2/3NCT04419584
Evaluate the Efficacy of Using Modified Qing-Ying Decoction in Atopic Dermatitis Children
A Phase 2/3 study testing Modified Qing-Ying Decoction in people with Atopic Dermatitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Modified Qing-Ying Decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Sep 2020to Aug 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of 4 to 17 (Chinese only);
- With EASI ≥ 10;
- Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and
- Provide written informed consent form (signed by one of their parents)
Who cannot join
- History of allergy to Chinese medicines;
- AD with Yang deficiency in syndrome differentiation, such as pale looking, always feeling cold, fatigue, chronic diarrhea with loose stool, urinary disorders such as urinary difficulty, excessive urination or incontinence
- Known overt bacterial infections in the skin;
- Known pregnancy;
- Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus;
- Having used oral corticosteroids, oral antibiotics, other immunosuppressive or any preparation of oral herbal medicines for the treatment of AD in the past month;
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- Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis or psoriasis; and
- Has taken anti-coagulant or anti-platelet drugs in the past month.
- Has taken any probiotics, prebiotics in the last month
- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Zhi-xiu Lin, PhD
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Modified Qing-Ying Decoction, Identical looking placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Qing-Ying DecoctionDrug
Herbal granules
Identical looking placeboDrug
Placebo granules
| Study group | Role | What they receive |
|---|---|---|
| Modified Qing-Ying Decoction | Experimental | Herbal granules, twice per day for 12 weeks Receives: Drug: Modified Qing-Ying Decoction |
| Identical looking placebo | Placebo comparator | Placebo granules, twice per day for 12 weeks Receives: Drug: Identical looking placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI)
Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis
Measured: 16 weeks
Secondary outcomes (3)
Patient Oriented Eczema Measure (POEM)
Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.
Measured: 16 weeks
Children's Dermatology Life Quality Index (CDLQI)
Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.
Measured: 16 weeks
Constitution of Chinese Medicine Questionnaire (CCMQ)
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start10 Sep 2020
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhi-xiu Lin, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419584
- Sponsor's protocol ID
- AD study
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2020
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04419584
- Acronym / sponsor ID
- AD study
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Qing-Ying Decoction | Experimental | Drug: Modified Qing-Ying DecoctionHerbal granules, twice per day for 12 weeks |
| Identical looking placebo | Placebo comparator | Drug: Identical looking placeboPlacebo granules, twice per day for 12 weeks |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age of 4 to 17 (Chinese only);
- With EASI ≥ 10;
- Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and
- Provide written informed consent form (signed by one of their parents)
Key exclusion criteria (10 listed)
- History of allergy to Chinese medicines;
- AD with Yang deficiency in syndrome differentiation, such as pale looking, always feeling cold, fatigue, chronic diarrhea with loose stool, urinary disorders such as urinary difficulty, excessive urination or incontinence
- Known overt bacterial infections in the skin;
- Known pregnancy;
- Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Qing-Ying DecoctionHerbal granules | Drug | Modified Qing-Ying Decoction |
| Identical looking placeboPlacebo granules | Drug | Identical looking placebo |
Primary outcome
Eczema Area and Severity Index (EASI)
Time frame: 16 weeks
Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis
3 secondary outcomes
Patient Oriented Eczema Measure (POEM)
Time frame: 16 weeks
Children's Dermatology Life Quality Index (CDLQI)
Time frame: 16 weeks
Constitution of Chinese Medicine Questionnaire (CCMQ)
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhi-xiu Lin, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Modified Qing-Ying Decoction in people with Atopic Dermatitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-him Sum (39433438, chsum@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.