Research Article

Chinese Herbal Formula Huoxiang Zhengqi for Dampness Pattern in Atopic Dermatitis and Diarrhea-Predominant Irritable Bowel Syndrome: Rationale and Design of a Master Protocol

Table 2

Inclusion and exclusion criteria for patient selection in the RCTs.

Inclusion criteriaExclusion criteria

Patients who meet all of the following criteria are eligible for the RCTs:Patients who meet any of the following criteria are not eligible to participate in the RCTs:
1. Patients between 18 and 70 years of age and informed consent obtained1. Patients with any uncontrolled cardiovascular, respiratory, digestive, urinary, or hematological disease; known cancer or mental illness
2. Diagnosed with CM dampness pattern2. Examination results show ALT or AST levels exceeding 2 times the upper limit normal value; or BUN level exceeds 1.5 times the upper limit normal value during the screening period
3. CHARM
(a) 1% < body surface area (BSA) < 10%
(b) 1 ≤ investigator’s global assessment (IGA) ≤ 3
3. Anyone allergic to any medicine or ingredients used in the study
4. Women who are pregnant or lactating or plan to become pregnant in three months
4. CHAIRS
(a) Initial irritable bowel syndromes symptom severity (IBS-SSS) score >75
(b) Patients had to be literate
5. Those who are considered unfit for the trial
6. CHARM
(a) those who have ever used HXZQ for treating eczema
(b) medication used: systemic therapy with immunomodulatory or immunosuppressive agents (including tripterygium wilfordii) within the previous 4 weeks; topical or systematic therapy with antibiotics or antihistamines within the previous 2 weeks phototherapy (such as PUVA, UVA, or UVB) within the previous 4 weeks; topical therapy with immunomodulator within the previous 2 weeks; or topical or systematic use of any over-the-counter drugs within the previous week
(c) those who are participating in any other clinical trial or had participated in a clinical trial within the previous month
7. CHAIRS
(a) Patients with warning signs (weight loss within 3 months of emaciation >10%), hematochezia that is confirmed not to have been caused by hemorrhoids or anal fissure, diarrhea at night, fever, family history of colorectal cancer (or polyposis syndrome), inflammatory bowel disease (IBD) or celiac disease
(b) Organic diseases of the digestive system, or systemic diseases that affect digestive tract dynamics
(c) Patients with a history of abdominal surgery (except caesarean section)
(d) Those who are unwilling or unable to stop using drugs that affect the evaluation of interventions during the study
(e) Standard points on the self-rating anxiety scale (SAS) > 50; standard points on the self-rating depression scale (SDS) > 53
(f) Those who have participated in other trials within the past 3 months

CHARM, Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern; CHAIRS, Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome; CM, Chinese Medicine.