ulcerative colitis
Conditions
Interventions
QingChangHuaShi Group:basic treatment and QingChangHuaShi Granule
QingChangHuaShi (low dose) Group:basic treatment and QingChangHuaShi (low dose) Granule
Sponsors
Jiangsu Province Hospital of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. A confirmed diagnosis of ulcerative colitis, using 5-ASA for at least 4 weeks: (1) the disease stage is still active phase; (2) the disease severity is moderate, score of 6 to 10 on the Mayo scale and moderately active disease on sigmoidoscopy (a Mayo endoscopic findings subscore of 2 or 3); 2. The TCM differentiation is damp-heat syndrome of large intestine; 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, liver, lung and Kidney, Blood system or other diseases affect living; such as Tumor, AIDS, Asthma, Kidney stones, Renal dysfunction; positive response on urinary protein, icroscopic red blood cells in urine more than 24/ul; ALTAbove the upper limit of normal; Clinically significant ECG abnormalities; PLT less than 100*10^9/L; WBC less than 4.0*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 involved in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical effecacy;Rate of clinical remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| endoscopic response rate;endoscopic remission rate;TCM clinical syndrome efficacy;Laboratory tests;recurernce rate; | — |
Countries
China
Contacts
Public ContactHong Shen
Outcome results
None listed