Clinical study of Shenling Baizhu Powder combined with Special Disease Prescription in the treatment of ulcerative colitis with dampness obstruction syndrome of spleen deficiency

Phase 1

Not yet recruiting

• Conditions: ulcerative colitis

• Registration Number: ITMCTR2200006064
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

(1) 18-75 years old, male or female;
(2) Meet the diagnostic criteria of ulcerative colitis;
(3) Meet the criteria of mild and moderate active stage of ulcerative colitis;
(4) Meet the criteria for waiting diagnosis of dampness obstruction syndrome of spleen deficiency;
(5) The informed consent is signed.

Exclusion Criteria

(1) Chronic schistosomiasis, bacterial dysentery, intestinal tuberculosis and other infectious colitis, colonic Crohn's disease, radiation enteritis, ischemic enteritis;
(2) Patients in lactation, pregnant women and intolerant to this drug;
(3) patients with serious primary diseases such as heart, lung, liver, kidney and hematopoietic system, and mental illness;
(4) Patients with serious complications such as local stenosis, toxic megacolon, intestinal obstruction, colon cancer, rectal cancer, intestinal perforation and anal diseases;
(5) persons with disabilities defined by law (mute, deaf, blind, mental disorder, physical disability, intellectual disability).
(6) Normal cognitive function, no dyslexia; Be able to actively cooperate and participate in investigation and research.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
C Disease activity index;

Secondary Outcome Measures

Name	Time	Method
Blood sedimentation and CRP;Ibd Quality of life Questionnaire;Intestinal mucosa endoscopic and pathological scores;