Effects of a Mixed Chinese Herbal Formula on Atopic Dermatitis

• Status: Not yet recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborators: National Yang Ming University; Taipei Medical University; Taipei Veterans General Hospital, Taiwan

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