Effects of a Mixed Chinese Herbal Formula on Atopic Dermatitis

NCT05455060 | Unknown Phase 3

• 1 other identifier: 202200262A3C602
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Chinese herbal formula; Clinical trial; Microbiota; Metabolomics analysis; Pharmacokinetic study

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  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

  Assess at the beginning of the study and after 12 weeks' treatment, total 2 times

• Changes of CRP level after a mixed CHF treatment

  Assess at the beginning of the study and after 12 weeks' treatment, total 2 times

• Changes of eosinophil count after a mixed CHF treatment

  Assess at the beginning of the study and after 12 weeks' treatment, total 2 times

• Changes of IgE level after a mixed CHF treatment

  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

  Assess at the beginning of the study and after 12 weeks' treatment, total 2 times

Study Arms (2)

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)

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)

Drug: Placebo

Interventions

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)

Chinese herbal formula (CHF)

Placebo 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.

Control

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Yang Ming Chiao Tung University: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Taipei Medical University: collaborator

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 13, 2022
• Study Start: December 15, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 6, 2022

Record last verified: 2022-12