Ulcerative colitis
Conditions
Interventions
Treatment group:Introduction period (1 week)
Mesalazine enteric-coated tablets 3.0g/day (2 tablets at a time, 3 times a day, taken orally 1 hour before meals)
Treatment period (12 weeks)
Mesalazine enteric-coated Tablet 3.0g/day (2 tablets at a time, 3 times a day, taken orally 1 hour before meals) + Kangfuxin enteric-coated capsule 18 tablets/day (6 tablet
Placebo group:Introduction period (1 week)
Mesalazine enteric-coated tablets 3.0g/day (2 tablets at a time, 3 times a day, taken orally 1 hour before meals)
Treatment period (12 weeks)
Mesalazine enteric-coated tablet 3.0g/day (2 tablets, 3 times a day, taken orally 1 hour before meals) + 18 placebo capsules/day (6 capsules, 3 times a day, taken orally 1
Sponsors
Tenth People's Hospital Affiliated to Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical trial and sign a written informed consent; 2. At least 18 years old, regardless of gender; 3. Consistent with Western medicine diagnosis of ulcerative colitis (Consensus Opinion on Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)); Clinical type: primary type or chronic recurrent type; Range of lesions: Montreal type E2 or E3; 4. For patients with mild or moderate active ulcerative colitis, 4 points = 2 points; 5. Female and male subjects of reproductive age and their spouses were willing to use effective contraception (medically approved contraceptive methods, such as Iuds, contraceptives or condoms) during the study medication period and within 6 months after the termination of medication.
Exclusion criteria
Exclusion criteria: 1. Those who have been identified as steroid-ineffective UC or steroid-dependent UC; steroid ineffective UC definition: after treatment with the equivalent dose of prednisone 0.75~1mg·kg/d for more than 4 weeks, the disease was still active. steroid-dependent UC definition: Although remission is maintained, prednisone does not decrease to 10 mg/d after 3 months of steroid therapy or relapse within 3 months of steroid discontinuation. 2. Pregnant or lactating women, subjects who have a birth plan in the past six months; 3. Patients with confirmed or suspected bacillary dysentery, amebic dysentery, intestinal schistosomiasis, intestinal tuberculosis, fungal colitis, antibiotic-associated colitis, eosinophilic colitis, Belcet's disease, Crohn's disease, ischemic enteritis, radiation enteritis, undefined colitis, colitis of the colon diverticulitis, and colorectal cancer; 4. Subjects whose disease was found to be confined to the rectum (ulcerative colitis rectal type) by endoscopy during screening; 5. The subjects have serious diseases of the heart, lung, liver, kidney, endocrine system, immune system, hematopoietic system and nervous system, which the investigators believe will interfere with the study results or endanger the safety of the subjects; 6. People who are allergic to the ingredients contained in rehabilitation new; Allergic to 5-aminosalicylic acid and its derivatives; 7. Colorectal surgery was expected to be required within 14 weeks after enrollment due to gastrointestinal diseases and operations that were judged by the investigators to affect drug absorption; 8. The subject has undergone small intestine or colon surgery and has evidence of colon dysplasia or intestinal stenosis; 9. Patients who had recently used other drugs to treat the disease, such as azathioprine, 6-mercaptopurine, methotrexate, tacrolimus, cyclosporine, or other immunosuppressive therapy within the first 6 weeks of admission; Prednisone, dexamethasone, or other glucocorticoid drugs were used within the first 6 weeks of enrollment; Patients who had been treated with anti-TNF-a mab within 8 weeks prior to enrollment (such as infliximab, Adalimumab, cetuzumab, etc.); Used other biologics or small molecule drugs such as Vederizumab, ulinumab, tofacitib, etc., within 8 weeks before enrollment; Treatment of ulcerative colitis within 2 weeks prior to enrollment with health food, traditional Chinese medicine decoction, Chinese patent medicine [such as Chang Ning tablet, Xianglian pill, Shenling Baizhu pill, Wumei pill, Guchang Zhixie pill, Bupi Yichang pill, Gubenyichang tablet, Coloning (enema), Huangbai lotion, Wuwei Kushen capsule, etc.], traditional Chinese medicine enema treatment (such as: Fuxing new liquid, Tuxing sore and muscle, activating blood stasis and cooling blood stasis, clearing heat and detoxification, such as tin powder, etc.); 10. Suspected or true history of alcohol and drug abuse; 11. Participants in other clinical trials within the last 3 months; 12. ALT or AST >= 1.5 times the upper limit of normal, Scr > the upper limit of normal; 13. Uncontrolled hypertension after systemic drug therapy (blood pressure >= 160/100mmHg at enrollment); 14. Diabetes mellitus with poor blood glucose control after systemic drug therapy (HbA1c >= 7% at enrollment); 15. There were complications in the first 4 weeks of enrollment, such as intestinal obstruction, intestinal perforation, toxic colonic dilation, gastrointestinal hemorrhage, and perianal lesions (an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical remission rate;endoscopic remission rate;changes from baseline in individual scores for modified Mayo endoscopy;changes from baseline in the total score of modified Mayo defecation + blood in stool; the Quality of Life analysis table of patients with inflammatory bowel disease (IBDQ The change in rating from baseline;histological clinical response rate (based on Geboes index rating); | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom remission rate; the proportion of subjects who achieved an endoscopic single score of 0;changes from baseline in the total score of modified Mayo symptoms + endoscopy; | — |
Countries
China
Contacts
Public ContactLiu Zhanju
Tenth People's Hospital Affiliated to Tongji University
Outcome results
None listed