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A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis

Phase 1
Conditions
ulcerative colitis
Registration Number
ITMCTR2000003558
Lead Sponsor
Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1) accord with the diagnostic standard of western medicine for ulcerative colitis;
2) the selected patients were mild to moderate ulcerative colitis (total Mayo score = 310);
3) Aged 18-65 years old;
4) agree to participate in this study and sign the informed letter at the same time.

Exclusion Criteria

(1) infectious colitis such as bacillary dysentery, amoebic dysentery, chronic schistosomiasis, intestinal tuberculosis, Crohn's disease and ischemic intestine;
Patients with inflammatory and radiation enteritis;
(2) there are serious complications such as local stenosis, intestinal obstruction, intestinal perforation, toxic colonic dilatation, massive hemorrhage, colon cancer and rectal cancer;
(3) patients with other primary and secondary infectious diseases, such as cholecystitis, pneumonia, etc.;
(4) patients with serious diseases of cardiovascular, hepatobiliary, lung, kidney and blood system;
(5) Women during pregnancy and lactation;
(6) patients with disabilities prescribed by law (blindness, deafness, mute, mental retardation, physical disability);
(7) patients with severe ulcerative colitis (Mayo=11~12 score); or patients with complications.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total Mayo score;Mayo endoscopic score;
Secondary Outcome Measures
NameTimeMethod
Fecal calcitonin;Score of curative effect of TCM syndrome;Mucosal histology;ESR;Fecal routine and occult blood;CRP;SIBDQ;
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