A Chinese herbal medicine (Xilei-san) for mild/moderate ulcerative proctitis
Not Applicable
Completed
- Conditions
- Mild or moderate ulcerative proctitisDigestive SystemUlcerative (chronic) proctitis
- Registration Number
- ISRCTN56157078
- Lead Sponsor
- Zhengzhou University (China)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical remission rate at week 4
- Secondary Outcome Measures
Name Time Method 1. Clinical and endoscopic remission rates at week 8<br>2. Clinical relapse rates at week 20<br>3. Adverse events were assessed at week 4, 8 and 20