Efficacy and Safety of Soshiho-tang in patients with Atopic dermatitis and Gastrointestinal disorders:
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0003713
- Lead Sponsor
- Wonkwang University. Iksan Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion criteria
Participating patients should meet all of the following inclusion criteria:
1.Males and females aged 3-18 years with Scoring Atopic Dermatitis score between 15 and 49, exhibiting =3 main and =3 accessory symptoms based on the diagnostic criteria developed by Hanifin & Rajka
2.Participants with =1 box checked for gastrointestinal symptoms or food allergy history, in the questionnaire survey for gastrointestinal disorders
3.Participants who have fully understood information provided about the study, voluntarily decided to participate, and agreed to comply with precautions (written consent is required from the participants’ parents)
Exclusion criteria
1.Patients receiving treatment for severe Atopic Dermatitis (such as antihistamines, adrenocortical hormones, or Korean traditional herbal medication)
2.Patients who have previously used oral antihistamines, steroids, antibiotics, systemic photochemotherapy, and other immune suppressants in the previous 4 weeks
3.Patients with systemic infection or under treatment with systemic antibiotics
4.Patients with severe dermatological disorders aside from Atopic Dermatitis, pigmentation, or large scarring of the area affected by Atopic Dermatitis
5.Patients currently receiving interferon drug treatment (i.e.,interferon -a, interferon -ß, etc.)
6.Patients with liver diseases (i.e., liver cirrhosis or liver cancer)
7.Patients with platelet count =100,000/mm3 due to chronic hepatitis-induced liver dysfunction
8.Patients with kidney diseases (i.e., acute/chronic renal failure, renal syndrome, etc.)
9.Patients with acute severe cardiovascular diseases (i.e., cardiac failure, myocardial infarction, cerebral infarction, etc.)
10.Patients with a history of antipsychotic drug use within 2 months prior to the screening examination
11.Patients who have participated in other clinical trials within the past 4 weeks
12.Patients with a history of hypersensitivity or allergic reaction to an ingredient of the clinical trial product or the product itself
13.Patients with a history of drug or alcohol abuse
14.Patients who are pregnant or breastfeeding
15.Patients who may become pregnant and have not used appropriate contraceptives (excluding those who have undergone sterilization surgery)
16.Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including diagnostic radiology outcomes
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SCORing Atopic Dermatitis Index
- Secondary Outcome Measures
Name Time Method Survey questionnaires for perception of gastrointestinal disorders;Amount and frequency of ointment usage for Atopic dermatitis;Children’s Dermatology Life Quality Index;Itchiness and sleep disability score in visual analogue scale;Skin moisture content;Skin surface temperature;Hamilton Anxiety Rating Scale;Children's Depression Inventory;Stress & Autonomic nervous system