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etwork Pharmacology Dissection of Multiscale Mechanisms for Jiaoqi Powder in Treating Ulcerative Colitis

Phase 1
Recruiting
Conditions
lcerative colitis
Registration Number
ITMCTR2100004421
Lead Sponsor
Department of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, No.16 of Road Airport, Baiyun district, Guangzhou 510405, Province Guangdong, China
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

The diagnosis of UC is based on the clinical manifestations, characteristic endoscopic and histopathological changes, and the exclusion of infectious bowel disease:
(1) The clinical manifestations are recurrent or persistent abdominal pain, diarrhea, tenesmus, mucus pus and blood in the stool, fever, fatigue and other systemic symptoms of varying degrees, and may have extraintestinal manifestations such as skin, mucous membranes, joints, eyes, liver and gallbladder. The course of the disease is more than 4-6 weeks.
(2) The characteristic manifestations under endoscopy are persistent and confluent colitis and rectal involvement. The texture of mucosal blood vessels is blurred, disordered or disappeared. In severe cases, mucosal texture, spontaneous bleeding and ulcer formation can be seen.
(3) Mucosal pathology examination: pathologically visible structural changes (crypt bifurcation, crypt structural deformation, crypt atrophy and surface irregularity), epithelial abnormalities (mucin depletion and Paneth cell metaplasia) and inflammatory response manifestations (Inflammatory cells in the lamina propria increased, basal plasma cells increased, lymphocytes increased, and lamina propria eosinophils increased).
(4) Exclude bacterial infectious enteritis, amoebic enteropathy, intestinal schistosomiasis, intestinal tuberculosis, fungal enteritis, human immunodeficiency virus infection, ischemic enteropathy, eosinophilic enteritis, Behcet's disease, etc. disease.
(5) Age 18-75 years old. The patient informed consent and was willing to receive corresponding treatment.

Exclusion Criteria

(1) Typical medical history, no report of colonoscopy, no histological evidence or uncertain histological examination. (2) Patients with abdominal pain, diarrhea, mucus, pus and blood in the stool due to organic diseases or with any other diseases that can explain the above clinical symptoms.
(3) Although ulcerative colitis is the first diagnosis, but other infectious or non-infectious colitis at the same time, or accompanied by serious surgical diseases such as toxic megacolon, intestinal obstruction, intussusception, intestinal bleeding Necrosis, stenosis, perforation, cancer, etc.
(4) Patients with a history of abdominal surgery, patients with a history of abdominal surgery, organic diseases of the digestive system (such as chronic pancreatitis, cirrhosis, etc.), or systemic diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency, etc.).
(5) People who are unconscious, dementia, various mental illnesses, severe neurosis and unwilling to cooperate.
(6) Severe primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease, autoimmune system disease, or serious disease that affects their survival, such as tumor or AIDS.
(7) Pregnant and lactating women.
(8) People with allergies or allergies to multiple drugs.
(9) Those who are allergic to the components of Chinese medicine; those who are participating in clinical trials of other drugs within 4 weeks.
(10) There are cognitive or other impairments (such as vision, etc.) that affect the participants to complete the self-report.
(11) Those who refuse to carry out drug elution.
(12) The investigator has good reason to believe that the participants current medical or psychological state is not suitable for the research.

Study & Design

Study Type
Observational study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Immune Cells;
Secondary Outcome Measures
NameTimeMethod
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