NCT04419584 Evaluate the Efficacy of Using Modified Qing-Ying Decoction in Atopic Dermatitis Children
| NCT ID | NCT04419584 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2020-09-10 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 64 participants in total. It began in 2020-09-10 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: 1. Age of 4 to 17 (Chinese only); 2. With EASI ≥ 10; 3. Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and 4. Provide written informed consent form (signed by one of their parents) Exclusion Criteria: 1. History of allergy to Chinese medicines; 2. 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 3. Known overt bacterial infections in the skin; 4. Known pregnancy; 5. Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus; 6. Having used oral corticosteroids, oral antibiotics, other immunosuppressive or any preparation of oral herbal medicines for the treatment of AD in the past month; 7. Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis or psoriasis; and 8. Has taken anti-coagulant or anti-platelet drugs in the past month. 9. Has taken any probiotics, prebiotics in the last month 10. Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Contact & Investigator
Zhi-xiu Lin, PhD
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT04419584 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 17 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04419584 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04419584 currently recruiting?
Yes, NCT04419584 is actively recruiting participants. Contact the research team at chsum@cuhk.edu.hk for enrollment information.
Where is the NCT04419584 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT04419584 clinical trial?
NCT04419584 is sponsored by Chinese University of Hong Kong. The principal investigator is Zhi-xiu Lin, PhD at Chinese University of Hong Kong. The trial plans to enroll 64 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.