Mild or moderate ulcerative proctitis Digestive System Ulcerative (chronic) proctitis
Conditions
Interventions
Dexamethasone was formulated as 5 mg/60 ml and Xilei-San as 1000 mg/60 ml (Beijing Tong Ren Tang Ltd., Co., Beijing, China). Patients were instructed to take the formulation as enema once a day for 4
Sponsors
Zhengzhou University (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients between the ages of 18 and 80 years were eligible to participate if they had previously established UP with mild to moderate exacerbation at least 7 days
Exclusion criteria
Exclusion criteria: 1. Patients receiving 5-aminosalicylic acid and/or immunosuppressive agents in 7 days prior to entry into the trial, except those suffering symptomatic relapse during maintenance treatment of oral 5-aminosalicylic acid (5-ASA) preparations 2. Patients currently or recently receiving any oral or rectal steroid preparation 3. Patients having any episode of drug allergy and 4. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate at week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical and endoscopic remission rates at week 8 2. Clinical relapse rates at week 20 3. Adverse events were assessed at week 4, 8 and 20 | — |
Countries
China
Outcome results
None listed