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A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis

A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003772
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Interventions

Sponsors

Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) it accords 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) 18-65 years old; regardless of sex. (4) agree to participate in this study and sign the informed letter at the same time.

Exclusion criteria

Exclusion criteria: (1) Patients with infectious colitis such as bacillary dysentery, amoebic dysentery, chronic schistosomiasis, intestinal tuberculosis, Crohn's disease, ischemic enteritis and radiation enteritis. (2) Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, toxic colonic dilatation, massive hemorrhage, colon cancer, 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.

Design outcomes

Primary

MeasureTime frame
Total Mayo score;Mayo endoscopic score;

Secondary

MeasureTime frame
TCM syndrome integral;ESR;Intestinal mucosal histopathology;Fecal calcitonin;C-reactive protein;

Countries

China

Contacts

Public ContactGu Sizhen

Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine

gusizhen@shutcm.edu.cn+86 15901904282

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026