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Effects of a Mixed Chinese Herbal Formula on Atopic Dermatitis

NCT05455060 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-12-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • National Yang Ming Chiao Tung University

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Taipei Medical University

    collaborator OTHER

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2025-07-31
Completion
2025-07-31

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05455060 on ClinicalTrials.gov