Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children

July 23, 2026 updated by: Prof. Lin Zhixiu, Chinese University of Hong Kong

A Randomized Placebo-Controlled Pilot Study of an Herbal Formula Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children

The study aims to evaluate the clinical efficacy of Chinese medicine (CM) for the treatment of subacute and chronic Atopic Dermatitis (AD) patients when compared to the placebo control by examining the clinical symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a parallel, randomized, placebo-controlled, double-blind pilot study. The subjects will come for a screening visit at week 0 (baseline), then at week 6±3 days, week 12±3 days and week 16±4 days for Chinese medicine practitioner (CMP) investigators' assessments (Fig 1). Eczema Area and Severity Index (EASI), Children's dermatology life quality index (CDLQI), and Patient-Oriented Eczema Measure (POEM) will be assessed and filled up at different time points. Eligible subjects will be randomly allocated to the treatment group receiving oral CM granules or the placebo control group receiving oral placebo granules for 12 weeks, and then be followed up 4 weeks after the treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 a written informed consent form (signed by one of their parents)

Exclusion Criteria:

  • 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;
  • Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis or psoriasis;
  • Has taken anti-coagulant or anti-platelet drugs in the past month;
  • Has taken any probiotics, prebiotics in the last month; and
  • Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo granules for 12 weeks twice daily
Experimental: Active treatment (Modified Huang-Lian-Jie-Du Decoction (MHLJDD))
Chinese medicine
Drug: Modified Huang-Lian-Jie-Du Decoction (MHLJDD)
Chinese medicine granules for 12 weeks twice daily
Other Names:
  • Chinese medicine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EASI score
Time Frame: 12 weeks
The change of EASI score for atopic dermatitis at week 12 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
EASI score
Time Frame: 6 weeks
The change of EASI score for atopic dermatitis at week 6 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis
6 weeks
EASI score
Time Frame: 16 weeks
The change of EASI score for atopic dermatitis at week16 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis
16 weeks
CDLQI score
Time Frame: 12 weeks
The change of CDLQI score at week 12 Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.
12 weeks
CDLQI score
Time Frame: 16 weeks
The change of CDLQI score at week 16 Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.
16 weeks
POEM score
Time Frame: 12 weeks
The change of POEM score at week 12 Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.
12 weeks
POEM score
Time Frame: 16 weeks
The change of POEM score at week 16 Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.
16 weeks
Microbiome
Time Frame: 12 weeks
The change of microbiome at week 12. The oral and gut microbiota are the collection of microbial agents such as bacteria, viruses and fungi that inhabit in the mouth cavity and gut. Bacterial microbiome sequencing is performed using 16S ribosomal RNA pyrosequencing.
12 weeks
Time of flare
Time Frame: 16 weeks
The time to reach flare (defined as major exacerbation disease increase > 50% of baseline EASI)
16 weeks
The number of subjects reaches flare
Time Frame: 16 weeks
The number of subjects reaches flare (defined as major exacerbation disease increase > 50% of baseline EASI)
16 weeks
Trans-epidermal water loss (TEWL)
Time Frame: 6 weeks
Trans-epidermal water loss (TEWL) at week 6 The Trans-epidermal water loss (TWEL) is measured in g/m2h, which range from 0 to 300. An increasing TEWL value indicates greater skin dryness.
6 weeks
Trans-epidermal water loss (TEWL)
Time Frame: 12 weeks
Trans-epidermal water loss (TEWL) at week 12 The Trans-epidermal water loss (TWEL) is measured in g/m2h, which range from 0 to 300. An increasing TEWL value indicates greater skin dryness.
12 weeks
Trans-epidermal water loss (TEWL)
Time Frame: 16 weeks
The change of trans-epidermal water loss (TEWL) at week 16 The TWEL is measured in g/m2h, which range from 0 to 300. An increasing TEWL value indicates greater skin dryness.
16 weeks
Skin hydration (SH)
Time Frame: 6 weeks
The change of skin hydration (SH) at week 6 The SH is measured in arbitrary units (a.u.), which range from 0 to 300 a.u.
6 weeks
Skin hydration (SH)
Time Frame: 12 weeks
The change of skin hydration (SH) at week 12 The SH is measured in arbitrary units (a.u.), which range from 0 to 300 a.u.
12 weeks
Skin hydration (SH)
Time Frame: 16 weeks
The change of skin hydration (SH) at week 16 Skin hydration will be measured topically using the measuring device at a standard site below the antecubital fossa of each patient's right arm. The SH is measured in arbitrary units (a.u.), which range from 0 to 300 a.u.
16 weeks
Adverse event
Time Frame: 16 weeks
Adverse event will be assessed in the study period
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhixiu Lin, Integrative Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AD HLJDD study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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