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Effect of Shenqing capsule on inducing mild to moderate active ulcerative colitis: a multicenter, randomized, double-blinded, parallelly positive controlled study

Effect of Shenqing capsule on inducing mild to moderate active ulcerative colitis: a multicenter, randomized, double-blinded, parallelly positive controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036768
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

ulcerative colitis

Interventions

Sponsors

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) active ulcerative colitis (mild to moderate), Mayo score >= 3; 2) the subjects between 18 and 70 years, male or female; 3) the subjects informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) severe ulcerative colitis or acute severe ulcerative colitis. 2) ulcerative proctitis. 3) patients with complications, such as intestinal obstruction, intestinal perforation, massive hemorrhage of lower digestive tract or perianal diseases. 4) pathological biopsy of colonic mucosa showed dysplasia or suspected carcinoma. 5) extra-colonic manifestations, such as skin and mucosal manifestations (oral ulcer, nodular erythema and pyoderma gangrenosum), joint lesions (such as peripheral arthritis, spinal arthritis, etc.), eye lesions (such as iritis, scleritis, uveitis, etc.), hepatobiliary diseases (such as primary sclerosing cholangitis, etc.), thromboembolic disease. 6) confirmed or suspected bacillary dysentery, amoebic dysentery, intestinal schistosomiasis, intestinal tuberculosis, fungal colitis, antibiotic-associated colitis, eosinophilic colitis, Behcet's disease, Crohn's disease, ischemic enteritis, radiation enteritis, undetermined colitis, colonic diverticulitis, etc. 7) 5-aminosalicylic acid and hormone were used in the past 1 month, immunosuppressants and biological agents were used in the last 3 months, etc. 8) complicated with severe respiratory, circulatory, endocrine, blood, urinary, neurological or other digestive diseases, malignant tumors. 9) the upper limit of serum creatinine > normal reference value, alanine aminotransferase, aspartate aminotransferase > 2x normal upper limits. 10) pregnant or lactating women, patients with recent fertility plans. 11) allergic constitution, history of allergy to mesalazine, Shenqing capsule or any excipients. 12) those who suspect or do have a history of alcohol or drug abuse. 13) those who have a history of anxiety or depression and need to take medication, or who have a history of mental illness. 14) according to the researcher's judgment, the subjects who has other conditions which are not suitable to participate in this clincial trial.

Design outcomes

Primary

MeasureTime frame
Mayo scoring;

Secondary

MeasureTime frame
colonscopy;colon mucosa specimen;ESR;CRP;FC;fecae routine +OB;

Countries

China

Contacts

Public ContactLinjiang

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

linjiang@longhua.net+86 18917763419

Outcome results

None listed

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