ulcerative colitis
Conditions
Interventions
TCM Group:Oral Chinese medicine Qinchang Lianyang Granule + Guanchang Fang granule
Control:Azathioprine
Sponsors
Affiliated Hospital of Nanjing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Steroid-dependent patients with ulcerative colitis; 2. The TCM differentiation is spleen kidney deficiency, damp-heat syndrome; 3. Male and female,age between 18-65; 4. Informed consent is signed.
Exclusion criteria
Exclusion criteria: 1. Subject with bacillary dysentery, Amoebic dysentery, Chronic schistosomiasis, Tuberculosis of the intestines and Crohn's disease, Ischemic colitis, Radiation enteritis; 2. Subject with serious complications such as Local stenosis, Intestinal obstruction, Intestinal perforation, Toxic colon dilatation, Bleeding, Colon Cancer, Colorectal cancer; 3. Woman who is pregnant or try to conceive. Woman who is breast-feeding baby; 4. Subjects with severe primary disease of heart, and lung diseases affect living; ALT Above the twice upper limit of normal; Cr Above the upper limit of normal; PLT less than 50*10^9/L; WBC less than 3.0*10^9/L; 5. Patients with disabilities in law; 6. Suspected or indeed alcohol, drug abuse history; 7. According to judgment of the investigator, having other diseases which may reduce the likelihood of participation or complex the participation; 8. Subject who is allergic, such as who is allergic to two or more medications or knowned medications; 9. Subject who is included in other clinical trials.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| endoscopic response rate;endoscopic remission rate;TCM clinical syndrome efficacy;Laboratory tests;Recurrence rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Clinical efficient rate;Reduction time and withdraw time of steroid;Clinical remission rate; | — |
Countries
China
Contacts
Public ContactHong Shen
Outcome results
None listed