Crohn's disease
Conditions
Interventions
Exposure group:Qingchang Tongluo decoction combined with ustekinumab
Non-exposed group:Ustekinumab
Sponsors
Affiliated Hospital of Nanjing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) meeting the diagnostic criteria of CD; (2) patients who met the diagnostic criteria of stenotic CD by imaging endoscopy or ultrasound; (3) Active lesions (simplified endoscopic score for Crohn's disease SES-CD > 2) on colonoscopy before treatment; (4) TCM syndrome differentiation belongs to the syndrome of damp heat and blood stasis; (5) age of 18-65 years old; (6) Informed consent and voluntary subjects. Informed consent was obtained in accordance with the GCP.
Exclusion criteria
Exclusion criteria: (1) history of ileocolonic surgery or surgical indications (complicated with complex fistula intestinal obstruction caused by fibrous stenosis intestinal perforation toxic colon dilatation massive bleeding colon cancer etc.); (2) Bacterial dysentery amoebic dysentery chronic schistosomiasis intestinal tuberculosis and other infectious colitis; (3) receiving total enteral nutrition or glucocorticoids; (4) severe organ dysfunction; (5) pregnant and lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate;Clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nutritional indicators;Traditional Chinese medicine syndrome evaluation standard;Inflammatory indicators;Intestinal ultrasound score;Disappear rate of intestinal stenosis;Endoscopic response/remission rate; | — |
Countries
China
Contacts
Public ContactZhu Lei
Affiliated Hospital of Nanjing University of Chinese Medicine
Outcome results
None listed