Ulcerative Colitis
Conditions
Interventions
Mesalazine group:Patients received enteric-coated mesalazine tablets (1 g three times daily
manufacturer: Kui Hua Pharmaceutical Group Jiamusi Luling Pharmaceutical Co., Ltd.
National Drug Approval Number: H19980148).
New Jinzhi+ (Baizhu–Huangbai) Group:Patients with the "Large Intestine Damp-Heat" UC pattern were treated with the "New Jinzhi+" regimen, comprising New Jinzhi capsules combined with Baizhu–Huangbai.
New Jinzhi+ (Baizhu–Fuling) Group:Patients with the "Spleen Deficiency and Dampness Encumbrance" UC pattern were administered the "New Jinzhi+" regimen, comprising New Jinzhi capsules combined with Ba
Sponsors
The Affiliated Hospital of Jiangxi University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients are eligible for inclusion in the study only when all of the following criteria are met: 1. Confirmed diagnosis of ulcerative colitis (UC) with supportive clinical, endoscopic, and histopathological evidence, further categorized by Traditional Chinese Medicine (TCM) syndrome differentiation as "Large Intestine Damp-Heat" or "Spleen Deficiency and Dampness Encumbrance" patterns;2. Age between 18 and 65 years;3. No prior use of corticosteroids, biological agents, or immunosuppressants within the past 4 weeks;4. No use of antibiotics affecting the intestinal microbiota within the past 2 weeks;5. No use of TCM formulas or Chinese patent medicines for UC treatment within the past week;6. No use of 5-aminosalicylic acid (5-ASA) drugs for at least 1 week prior to enrollment;7. UC diagnosis classified as being in the active phase, with disease severity falling within the mild-to-moderate range;8. Voluntary participation with a signed informed consent form and willingness to comply with the study protocol.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study:1.Presence of high-grade mechanical intestinal obstruction, severe dynamic ileus, uncontrolled intestinal fistula, intra-abdominal infection, high-output diarrhea, uncontrolled sepsis, toxic megacolon, high suspicion of malignancy, or active major gastrointestinal hemorrhage in UC patients;2.Recent receipt of high-risk immunosuppressive or cytotoxic therapy (e.g., rituximab, doxorubicin, or moderate-to-high dose corticosteroids = 20 mg/d prednisone for a duration of = 4 weeks);3.Severe immunosuppression, defined as an absolute neutrophil count (ANC) < 1,500/mm³ in adults or < 1,000/mm³ in children;4.Women who are currently pregnant or lactating;5.Patients with congenital or acquired immunodeficiency diseases;6.Concurrent uncontrolled major systemic diseases that may increase treatment-related risks, including but not limited to cardiovascular, endocrine/metabolic, hematological, respiratory, or immune system disorders;7.A history of extensive colectomy, subtotal or total colectomy, or other relevant gastrointestinal surgical procedures;8.Known hypersensitivity or allergy to fecal microbiota transplantation (FMT) or specific components of the traditional Chinese medicine (TCM) formula;9.Current participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of therapeutic efficacy on TCM syndromes;Endoscopic evaluation;Histological evaluation;Microbiota assessment;IBDQ;Cytokine Detection; | — |
Countries
China
Contacts
Public ContactLeichang-Zhang
The Affiliated Hospital of Jiangxi University of Chinese Medicine
Outcome results
None listed