Crohn's Disease
Conditions
Interventions
Control Group:Received Infliximab induction therapy at Weeks 0 2 and 6 at a dose of 5 mg/kg.
Experimental Group:Gu Pi Sheng Ji Hua Zhuo Jie Du decoction (GHD)
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine Fangcun Branch Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Clinical Eligibility: Confirmed CD diagnosis per Western medical criteria with disease duration =6 months and BEST-CDAI score 150–450 or SES-CD score 3–15 (active disease). 2. Consent and Compliance: Willingness to provide written informed consent ability to understand the experimental protocol and commitment to adhere to study procedures. 3. Demographic Eligibility: Age range of 18–60 years old.
Exclusion criteria
Exclusion criteria: 1.Use of cyclosporine methotrexate or other investigational drugs within 3 months prior to screening. 2.Symptomatic gastrointestinal stenosis or ileal stenosis. 3.Presence of ostomy. 4.History of rectal colectomy or total colectomy. 5.Allergy to murine protein. 6.Prior treatment with murine chimeric or humanized monoclonal antibodies. 7.Intravenous corticosteroid or adrenocorticotropic hormone (ACTH) use within 4 weeks prior to screening. 8.Severe gastrointestinal complications (e.g. major bleeding perforation refractory obstruction or malignancy). 9.Pregnant or breastfeeding women. 10.Inability to comply with study requirements (e.g. dietary control or medication adherence). 11.Active tuberculosis or other active infections (e.g. sepsis abscesses opportunistic infections). 12.Moderate-to-severe heart failure (NYHA Class III/IV) hepatitis or renal insufficiency. 13.Coexisting psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| simple endoscopic score for CD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythrocyte Sedimentation Rate (ESR);Best-CDAI;Fecal Calprotectin;C-Reactive Protein (CRP); | — |
Countries
China
Contacts
Public ContactYan Chen
Guangdong Provincial Hospital of Traditional Chinese Medicine Fangcun Branch Hospital
Outcome results
None listed