ulcerative colitis
Conditions
Interventions
experimental group:Mesalazine extended-release granules 3g daily + Shenyu Enema Decoction 100mL enema daily
control group:Mesalazine extended-release granules 3g daily + Mesalazine enema 1 enema daily
Sponsors
Jiangsu Province Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meeting the western diagnostic criteria for UC: (1) Active stage of disease with a Mayo score of 3 to 10 and a Mayo endoscopic subscore of 2 or more; (2) Mild to moderate disease severity; (3) Lesion extent of the left hemicolectomy type; 2. Aged 18-65 years; 3. Knowledge of the enema procedure; 4. Informed consent and volunteering to be tested. The process of obtaining informed consent should be in accordance with ethical principles.
Exclusion criteria
Exclusion criteria: 1. Patients with a severe degree of disease, with lesions in the rectum, extensive colon, in remission; 2. Patients with infectious colitis such as bacillary dysentery, amebic dysentery, chronic schistosomiasis, intestinal tuberculosis and patients with Crohn's disease, ischaemic enteritis and radiation enteritis; 3. Patients with severe complications such as local stricture, intestinal obstruction, intestinal perforation, toxic colonic dilatation, haemorrhage, colon cancer, rectal cancer; 4. Patients with pulmonary, hepatic or renal dysfunction, and severe haematological disorders; 5. Women during pregnancy and lactation; 6. Patients with disabilities as defined by law (blind, deaf, mute, mentally handicapped, mentally handicapped, physically handicapped); 7. Patients with a suspected or confirmed history of alcohol or drug abuse; 8. Other pathologies which, in the judgement of the investigator, have the potential to reduce or complicate enrolment, such as frequent changes in the work environment and other conditions likely to cause loss of access; 9. Patients with allergies, asthma or a history of allergy treatment; those with a known hypersensitivity to mesalazine, salicylic acid and its derivatives, potassium metabisulphite, or to the components of this drug; 10. Patients who are participating in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficiency rate;Clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic response rate;Mucosal healing rate;Chinese medicine evidence of efficacy;Improvement and disappearance rate of individual symptom scores;Changes in CRP, ESR and faecal calprotectin from baseline;Patient Reported Outcome Scale; | — |
Countries
China
Contacts
Public ContactZhu Lei
Jiangsu Province Hospital of Chinese Medicine
Outcome results
None listed