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

Phase 1

• Conditions: ulcerative colitis

• Registration Number: ITMCTR2000003683
• Lead Sponsor: onghua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mayo scoring;

Secondary Outcome Measures

Name	Time	Method
CRP;fecae routine +OB;ESR;colonscopy;colon mucosa specimen;FC;