Atopic DermatitisPhase 3NCT05455060
Effects of a Mixed Chinese Herbal Formula on Atopic Dermatitis
A Phase 3 study testing Chinese herbal formula (CHF) in people with Atopic Dermatitis, run by Chang Gung Memorial Hospital.
Trial summary
The aim of this study is to investigate the clinical therapeutic effects of a mixed Chinese herbal formula (CHF) in treating atopic dermatitis (AD) based on its effects on cytokine levels and immune cell counts. Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Chinese herbal formula (CHF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2022to 31 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All volunteers must sign an informed consent form.
- Male and female patients aged 6 to 60 years.
- Patients who are diagnosed with AD by expert clinicians at Taoyuan, Linkou or Taipei Chang Gung Memorial Hospital and Taipei Veterans General Hospital in Taiwan and met the criteria of Hanifin and Rajka diagnostic criteria will be considered for enrollment in this study.
- SCORing Atopic Dermatitis (SCORAD) score ≧ 25
Who cannot join
- Other skin diseases that are not AD, such as contact dermatitis, seborrheic dermatitis, or drug-induced dermatitis, which will be diagnosed by expert clinicians
- Patients with other itching skin diseases at the same time, diagnosed by expert clinicians
- Patients who have secondary bacterial infections or receiving oral or intravenous steroid treatment, antibiotics, leukotriene modifiers, phototherapy or other immunosuppressive therapies in the previous 1 month
- Patients who cannot take the medicine regularly, or who can not cooperate in writing the questionnaires or taking blood tests
- Allergy to Chinese medicine or use of other Chinese medicine treatments
- Severe organ dysfunction, such as impaired renal and hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and AST, ALT ≥3 × the upper normal limit), liver cirrhosis, or heart failure
- Uncontrolled psychiatric problems or other severe systemic diseases
- Current pregnant or breast-feeding women, and all women of childbearing age must agree to take appropriate contraceptive precautions
About this study
Official title: Evaluation of Clinical Efficacy and Pharmacological Mechanism of a Mixed Chinese Herbal Formula in Atopic Dermatitis Patients by Integrating Metabolomics and Pharmacokinetic Analysis
The aim of this study is to investigate the clinical therapeutic effects of a mixed Chinese herbal formula (CHF) in treating atopic dermatitis (AD) based on its effects on cytokine levels and immune cell counts. Th1/Th2/Th17/Th22-related cytokines will be assayed to determine the mechanisms of the anti-inflammatory and immunomodulatory effects of the mixed CHF in AD patients. The nature of the microbiome dysfunction underlying this disease will be explored. Investigators will also apply a metabolomics approach to reveal the plasma metabolites in AD patients of different TCM patterns as well as to monitor changes of plasma metabolome in AD patients under mixed CHF treatment, aiming to develop metabolic biosignatures for efficacy of mixed CHF in AD patients exhibiting specific TCM pattern. PK study will be conducted to exam blood concentration of the prescription in healthy volunteers and AD patients with good or poor drug response. The results will provide evidence for the precision treatment based on different TCM pattens of AD patients. Completion of this integrated project will provide innovative information for future clinical applications.
Read the detailed description
In this study, a randomized, double-blinded, placebo control trial is designed and total 120 AD patients will be enrolled. All participants will be divided into Chinese herbal formula (CHF) and placebo control groups, in 2:1 allocation ratio. CHF group will receive capsules of mixture CHF; while control group will receive placebo capsules with similar look, smell, and taste with same scheme. Total 12-week treatment course will be done.
Aim 1: The effects and immunomodulatory mechanisms of a mixed CHF in AD patients with different TCM patterns
1A: Measurement of AD severity by Scoring of AD (SCORAD) scale and assessment of health-related quality of life using the Dermatology Life Quality Index (DLQI) or Children's Dermatology Life Quality Index (CDLQI)
1B: Reduction rate of exposure to western medicine after a mixed CHF treatment
1C: The effects of CHF treatment on CRP, ESR, eosinophil count, IgE, CD4+/CD8+ and related cytokines / signaling pathway involved in AD regulation
- D: Safety evaluation by measuring side effects, hemogram, electrolytes, kidney and liver function Aim 2: Effects of a mixed CHF on gut microbiota in AD patients
- A: Fecal DNA purification and 16S rRNA gene sequencing before and after CHF treatment
2B: Bioinformatics analysis to explore microbial dysfunction underlying AD and changes of gut microbiome after CHF treatment 2C: Determination of short-chain fatty acid (SCFA) levels in fecal samples before and after CHF treatment Aim 3: Effects of a mixed CHF on plasma metabolomes of AD patients 3A: Plasma metabolomics analysis in AD patients with different TCM patterns 3B: Plasma metabolomics analysis in AD patients under a mixed CHF treatment 3C: Determination of the previously known immunomodulatory metabolites in AD patients under a mixed CHF treatment Aim 4: PK study between healthy volunteers, valid patients, and patients with poor response to the mixed CHF 4A: Preparation and quality control of target prescription 4B: PK study of the mixed CHF
- Conditions
- Atopic Dermatitis
- Being tested
- Chinese herbal formula (CHF), Placebo
- Keywords
- Atopic dermatitis, Chinese herbal formula, Clinical trial, Microbiota, Metabolomics analysis, Pharmacokinetic study
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal formula (CHF)Drug
Each CHF capsule, weighing 500mg, is composed of Xiao-Feng-San 200mg, Zhen-Ren-Huo-Ming-Yin 200mg, Dictamnus dasycarpus 50mg and Houttuynia cordata 50mg. Patients will take the medicine 2 times a day (6gm BID for BW≥40kg), for 12 weeks, and the dosage will be modified according to patients' body weight. (3gm BID for 20kg≦BW<40kg; 1.5gm BID for BW<20kg)
PlaceboDrug
The patients in control group will take the placebo capsules, which has the similar look, smell, and taste. The dosage, frequency, and duration are the same as CHF group.
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbal formula (CHF) | Experimental | The patients in CHF group will take CHF capsules, 12 capsules (6 gm) twice a day, total 12 gm a day for 12 weeks, and the dosage will be modified according to patients' body weight. (3gm BID for 20kg≦BW<40kg; 1.5gm BID for BW<20kg) Receives: Drug: Chinese herbal formula (CHF) |
| Control | Placebo comparator | The patients in control group will take the placebo capsules, which has the similar look, smell, and taste. The dosage, frequency, and duration are the same as CHF group, in which 12 capsules (6 gm) twice a day, total 12 gm a day for 12 weeks, and the dosage will be modified according to patients' body weight. (3gm BID for 20kg≦BW<40kg; 1.5gm BID for BW<20kg) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of SCORing Atopic Dermatitis (SCORAD) score after treatment with a mixed CHF (composed of Xiao-Feng-San + Zhen-Ren-Huo-Ming-Yin + Dictamnus dasycarpus + Houttuynia cordata)
Measurement of symptoms related to AD including the severity of eczema, pruritis, and insomnia. The score ranges from 0 to 103 and higher scores mean a worse outcome.
Measured: Assess at the beginning of the study and after 6 and 12 weeks' treatment, total 3 times
Changes of Dermatology Life Quality Index (DLQI) score (use Children's Dermatology Life Quality Index, CDLQI, for patients at the ages of 6 to 16 years) after treatment with a mixed CHF
Measurement of quality of life.The score ranges from 0 to 30 and higher scores mean a worse outcome.
Measured: Assess at the beginning of the study and after 6 and 12 weeks' treatment, total 3 times
Changes of exposure to western medicine by recording the name and dosage of western medicine used for AD treatment
To explore whether the use of western medicine could be reduced after treatment with a mixed CHF
Measured: Assess at the beginning of the study, then weekly, up to 12 weeks
Secondary outcomes (12)
Changes of ESR level after a mixed CHF treatment
Evaluation of serologic markers related to AD
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of CRP level after a mixed CHF treatment
Evaluation of serologic markers related to AD
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of eosinophil count after a mixed CHF treatment
Evaluation of serologic markers related to AD
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of IgE level after a mixed CHF treatment
Evaluation of serologic markers related to AD
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of CD4/CD8 ratio after a mixed CHF treatment
Evaluation of serologic markers related to AD
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of IL-4, IL-5, IL-10, IL-12, IL-13, IL-17, IL-22, IL-23, and INF-γ level after a mixed CHF treatment
Evaluation of serologic markers related to AD
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of JAK1, JAK2, JAK3, tyrosine kinase-2 (TYK2), STAT1, STAT2, STAT3, STAT4, and STAT5 level after a mixed CHF treatment
Evaluation of JAK-STAT signaling pathway
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of gut microbiota
Differences of gut microbiota in AD patients with different TCM patterns before and after treatment and the effects of altered gut microbial colonization on the severity of AD
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Differences in the AD-associated metabolites (phosphatidylcholine, acylcarnitine) between AD patients with different TCM patterns after a mixed CHF treatment
To investigate whether plasma concentrations of these known metabolites are associated with the efficacy of a mixed CHF treatment in AD patients
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Differences in the anti-inflammatory metabolites (itaconate and its derivative, 4-octyl itaconate) between AD patients with different TCM patterns after a mixed CHF treatment
To investigate whether plasma concentrations of these known metabolites are associated with the efficacy of a mixed CHF treatment in AD patients
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Compare blood concentration of mixed CHF between AD patients with different TCM patterns after a mixed CHF treatment by PK study
The maximal measured plasma concentration (Cmax) will be taken
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Concentration-time profile of mixed CHF between AD patients with different TCM patterns after a mixed CHF treatment by PK study
The time at which the maximal plasma concentration observed (Tmax) will be taken from the observed plasma concentration-time profile
Measured: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start15 Dec 2022 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (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 Chang Gung Memorial HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University, Taipei Veterans General Hospital, Taiwan, Taipei Medical University
- Responsible party
- Principal investigator, YANG SIEN-HUNG, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455060
- Sponsor's protocol ID
- 202200262A3C602
- Status last verified
- Dec 2022
- First submitted
- 22 Jun 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacy and Pharmacological Mechanism of a Mixed Chinese Herbal Formula in Atopic Dermatitis Patients by Integrating Metabolomics and Pharmacokinetic Analysis
- ClinicalTrials.gov ID
- NCT05455060
- Acronym / sponsor ID
- 202200262A3C602
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Chinese herbal formula, Clinical trial, Microbiota, Metabolomics analysis, Pharmacokinetic study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University, Taipei Veterans General Hospital, Taiwan, Taipei Medical University
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 13 Jul 2022 (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 aim of this study is to investigate the clinical therapeutic effects of a mixed Chinese herbal formula (CHF) in treating atopic dermatitis (AD) based on its effects on cytokine levels and immune cell counts. Th1/Th2/Th17/Th22-related cytokines will be assayed to determine the mechanisms of the anti-inflammatory and immunomodulatory effects of the mixed CHF in AD patients. The nature of the microbiome dysfunction underlying this disease will be explored. Investigators will also apply a metabolomics approach to reveal the plasma metabolites in AD patients of different TCM patterns as well as to monitor changes of plasma metabolome in AD patients under mixed CHF treatment, aiming to develop metabolic biosignatures for efficacy of mixed CHF in AD patients exhibiting specific TCM pattern. PK study will be conducted to exam blood concentration of the prescription in healthy volunteers and AD patients with good or poor drug response. The results will provide evidence for the precision treatment based on different TCM pattens of AD patients. Completion of this integrated project will provide innovative information for future clinical applications.
Detailed description
In this study, a randomized, double-blinded, placebo control trial is designed and total 120 AD patients will be enrolled. All participants will be divided into Chinese herbal formula (CHF) and placebo control groups, in 2:1 allocation ratio. CHF group will receive capsules of mixture CHF; while control group will receive placebo capsules with similar look, smell, and taste with same scheme. Total 12-week treatment course will be done.
Aim 1: The effects and immunomodulatory mechanisms of a mixed CHF in AD patients with different TCM patterns
1A: Measurement of AD severity by Scoring of AD (SCORAD) scale and assessment of health-related quality of life using the Dermatology Life Quality Index (DLQI) or Children's Dermatology Life Quality Index (CDLQI)
1B: Reduction rate of exposure to western medicine after a mixed CHF treatment
1C: The effects of CHF treatment on CRP, ESR, eosinophil count, IgE, CD4+/CD8+ and related cytokines / signaling pathway involved in AD regulation
- D: Safety evaluation by measuring side effects, hemogram, electrolytes, kidney and liver function Aim 2: Effects of a mixed CHF on gut microbiota in AD patients
- A: Fecal DNA purification and 16S rRNA gene sequencing before and after CHF treatment
2B: Bioinformatics analysis to explore microbial dysfunction underlying AD and changes of gut microbiome after CHF treatment 2C: Determination of short-chain fatty acid (SCFA) levels in fecal samples before and after CHF treatment Aim 3: Effects of a mixed CHF on plasma metabolomes of AD patients 3A: Plasma metabolomics analysis in AD patients with different TCM patterns 3B: Plasma metabolomics analysis in AD patients under a mixed CHF treatment 3C: Determination of the previously known immunomodulatory metabolites in AD patients under a mixed CHF treatment Aim 4: PK study between healthy volunteers, valid patients, and patients with poor response to the mixed CHF 4A: Preparation and quality control of target prescription 4B: PK study of the mixed CHF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese herbal formula (CHF) | Experimental | Drug: Chinese herbal formula (CHF)The patients in CHF group will take CHF capsules, 12 capsules (6 gm) twice a day, total 12 gm a day for 12 weeks, and the dosage will be modified according to patients' body weight. (3gm BID for 20kg≦BW<40kg; 1.5gm BID for BW<20kg) |
| Control | Placebo comparator | Drug: PlaceboThe patients in control group will take the placebo capsules, which has the similar look, smell, and taste. The dosage, frequency, and duration are the same as CHF group, in which 12 capsules (6 gm) twice a day, total 12 gm a day for 12 weeks, and the dosage will be modified according to patients' body weight. (3gm BID for 20kg≦BW<40kg; 1.5gm BID for BW<20kg) |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All volunteers must sign an informed consent form.
- Male and female patients aged 6 to 60 years.
- Patients who are diagnosed with AD by expert clinicians at Taoyuan, Linkou or Taipei Chang Gung Memorial Hospital and Taipei Veterans General Hospital in Taiwan and met the criteria of Hanifin and Rajka diagnostic criteria will be considered for enrollment in this study.
- SCORing Atopic Dermatitis (SCORAD) score ≧ 25
Key exclusion criteria (8 listed)
- Other skin diseases that are not AD, such as contact dermatitis, seborrheic dermatitis, or drug-induced dermatitis, which will be diagnosed by expert clinicians
- Patients with other itching skin diseases at the same time, diagnosed by expert clinicians
- Patients who have secondary bacterial infections or receiving oral or intravenous steroid treatment, antibiotics, leukotriene modifiers, phototherapy or other immunosuppressive therapies in the previous 1 month
- Patients who cannot take the medicine regularly, or who can not cooperate in writing the questionnaires or taking blood tests
- Allergy to Chinese medicine or use of other Chinese medicine treatments
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 |
|---|---|---|
| Chinese herbal formula (CHF)Each CHF capsule, weighing 500mg, is composed of Xiao-Feng-San 200mg, Zhen-Ren-Huo-Ming-Yin 200mg, Dictamnus dasycarpus 50mg and Houttuynia cordata 50mg. Patients will take the medicine 2 times a day (6gm BID for BW≥40kg), for 12 weeks, and the dosage will be modified according to patients' body weight. (3gm BID for 20kg≦BW<40kg; 1.5gm BID for BW<20kg) | Drug | Chinese herbal formula (CHF) |
| PlaceboThe patients in control group will take the placebo capsules, which has the similar look, smell, and taste. The dosage, frequency, and duration are the same as CHF group. | Drug | Control |
Primary outcome
Changes of SCORing Atopic Dermatitis (SCORAD) score after treatment with a mixed CHF (composed of Xiao-Feng-San + Zhen-Ren-Huo-Ming-Yin + Dictamnus dasycarpus + Houttuynia cordata)
Time frame: Assess at the beginning of the study and after 6 and 12 weeks' treatment, total 3 times
Measurement of symptoms related to AD including the severity of eczema, pruritis, and insomnia. The score ranges from 0 to 103 and higher scores mean a worse outcome.
Changes of Dermatology Life Quality Index (DLQI) score (use Children's Dermatology Life Quality Index, CDLQI, for patients at the ages of 6 to 16 years) after treatment with a mixed CHF
Time frame: Assess at the beginning of the study and after 6 and 12 weeks' treatment, total 3 times
Measurement of quality of life.The score ranges from 0 to 30 and higher scores mean a worse outcome.
Changes of exposure to western medicine by recording the name and dosage of western medicine used for AD treatment
Time frame: Assess at the beginning of the study, then weekly, up to 12 weeks
To explore whether the use of western medicine could be reduced after treatment with a mixed CHF
12 secondary outcomes
Changes of ESR level after a mixed CHF treatment
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of CRP level after a mixed CHF treatment
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of eosinophil count after a mixed CHF treatment
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of IgE level after a mixed CHF treatment
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of CD4/CD8 ratio after a mixed CHF treatment
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of IL-4, IL-5, IL-10, IL-12, IL-13, IL-17, IL-22, IL-23, and INF-γ level after a mixed CHF treatment
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of JAK1, JAK2, JAK3, tyrosine kinase-2 (TYK2), STAT1, STAT2, STAT3, STAT4, and STAT5 level after a mixed CHF treatment
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Changes of gut microbiota
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Differences in the AD-associated metabolites (phosphatidylcholine, acylcarnitine) between AD patients with different TCM patterns after a mixed CHF treatment
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Differences in the anti-inflammatory metabolites (itaconate and its derivative, 4-octyl itaconate) between AD patients with different TCM patterns after a mixed CHF treatment
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Compare blood concentration of mixed CHF between AD patients with different TCM patterns after a mixed CHF treatment by PK study
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Concentration-time profile of mixed CHF between AD patients with different TCM patterns after a mixed CHF treatment by PK study
Time frame: Assess at the beginning of the study and after 12 weeks' treatment, total 2 times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chinese herbal formula (CHF) in people with Atopic Dermatitis, run by Chang Gung Memorial Hospital.
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 8 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of SCORing Atopic Dermatitis (SCORAD) score after treatment with a mixed CHF (composed of Xiao-Feng-San + Zhen-Ren-Huo-Ming-Yin + Dictamnus dasycarpus + Houttuynia cordata) (time frame: Assess at the beginning of the study and after 6 and 12 weeks' treatment, total 3 times). The study lists 3 primary outcomes in all. 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 6 Dec 2022.