Effects of a Mixed Chinese Herbal Formula on Atopic Dermatitis

NCT ID: NCT05455060

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2025-07-31

Brief 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. 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

1. 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

2. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Chinese herbal formula (CHF)

Intervention Type: 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)

Control

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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)

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. All volunteers must sign an informed consent form.

2. Male and female patients aged 6 to 60 years.

3. 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.

4. SCORing Atopic Dermatitis (SCORAD) score ≧ 25

Exclusion Criteria

1. Other skin diseases that are not AD, such as contact dermatitis, seborrheic dermatitis, or drug-induced dermatitis, which will be diagnosed by expert clinicians

2. Patients with other itching skin diseases at the same time, diagnosed by expert clinicians

3. 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

4. Patients who cannot take the medicine regularly, or who can not cooperate in writing the questionnaires or taking blood tests

5. Allergy to Chinese medicine or use of other Chinese medicine treatments

6. 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

7. Uncontrolled psychiatric problems or other severe systemic diseases

8. Current pregnant or breast-feeding women, and all women of childbearing age must agree to take appropriate contraceptive precautions

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

YANG SIEN-HUNG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

202200262A3C602

Identifier Type: -

Identifier Source: org_study_id