Chronic ulcerative colitis
Conditions
Interventions
Sponsors
Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for healthy subjects: 1. Those aged between 18 and 75 are not limited to men and women; 2. Subjects with BMI between 18 and 26 kg / m2; 3. The subjects who had no previous intestinal diseases and normal stool pattern had no history of using antibiotics and intestinal flora preparations in the past month; 4. The subjects with history of hypertension, heart disease, diabetes, tuberculosis and hepatitis were excluded by physical examination and laboratory examination; 5. The subjects agreed to participate in this study and signed the informed consent form. The informed consent process was in accordance with the quality management rules of drug clinical trials (GCP). Inclusion criteria: Patients with chronic ulcerative colitis 1. Patients with ulcerative colitis diagnosed by western medicine were classified into chronic recurrent type and / or chronic persistent type; 2. Patients with spleen and kidney yang deficiency syndrome, spleen deficiency and dampness accumulation syndrome and large intestine dampness heat syndrome; 3. Patients between 18 and 75 years old, male or female; 4. The patients who agreed to participate in this study were willing to accept the relevant examination and signed the informed consent form. The informed consent process was in line with the quality management rules of drug clinical trials (GCP).
Exclusion criteria
Exclusion criteria: 1. Patients with severe complications, such as toxic megacolon, intestinal obstruction, stenosis, perforation and canceration; 2. Pregnant or lactating women; 3. Patients with serious diseases such as hematopoietic system, liver, kidney and endocrine system; 4. Patients with mental diseases; 5. Patients with suspected or definite history of alcohol or drug abuse; 6. Patients who are using drugs that may affect gastrointestinal function; 7. Patients with allergic history and severe food allergy to the related drugs used in this study; 8. Patients who are participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baron endoscopic score;Disease severity and patient activity (modified Mayo score);Gebones index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool routine examination (+ occult blood test);Individual and overall scores of main symptoms;Symptom and syndrome integral scale of Traditional Chinese Medicine;Inflammation index (CXCL8 and ICAM-1);Blood routine examination;Renal function examination;Liver function examination; | — |
Countries
China
Contacts
Public ContactZhang Shuxin
Dongzhimen Hospital of Beijing University of traditional Chinese Medicine
Outcome results
None listed