Ulcerative colitis Digestive System
Conditions
Interventions
Participants are randomly allocated to one of two groups using SAS9.10 software:
1. Qingrehuashiquyu recipe 200ml, taken orally two times per day and mesalazine 0.25g,taken orally four
Sponsors
Beijing Municipal Science & Technology Commission
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The diagnosis of ulcerative colitis is active, and the clinical severity is mild to moderate. 2. Meeting the Traditional Chinese Medicine syndrome of large intestinal damp-heat criteria. 3. The age is between 18 and 65 years old, and gender is not limited. 4. The patient signs informed consent. The process of obtaining informed consent should be in accordance with GCP regulations.
Exclusion criteria
Exclusion criteria: 1. The type of ulcerative colitis is acute fulminant, and the severity of the condition is severe. 2. Infectious colitis such as bacillary dysentery, amoebic sputum, chronic schistosomiasis, intestinal tuberculosis, and patients with Crohn's colitis, ischemic enteritis, and radiation enteritis. 3. Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic colonic dilatation, colon cancer, rectal cancer and anal disease. 4. Pregnant and lactating women 5. Those with severe primary heart, liver, lung, kidney, blood or serious diseases that affect their survival. 6. Disabled patients prescribed by law. 7. Suspected or indeed had a history of alcohol and drug abuse. 8. Poor compliance or any other reason the researchers believe may not be appropriate to participate in this trial. 9. Allergic constitution or known to be allergic to the drug used in this trial. 10. Patients who are participating in other drug clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 29/10/2021: Mayo Activity Index, assessed at baseline and 12 weeks Previous primary outcome measure: Mucosal histology score measured using Geboes index, assessed at baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/10/2021: 1. Mucosal histology score measured using Geboes index, assessed at baseline and 12 weeks 2. Traditional Chinese Medicine syndromes of UC score, assessed at baseline,4,8 and 12weeks 3. Fecal occult blood test, erythrocyte sedimentation rate, C-reactive protein, fecal calprotectin at baseline and 12weeks 4. Detection of intestinal apoptosis at baseline and 12 weeks 5. Detection of intestinal flora at baseline and 12 weeks 6. Detection of intestinal nitric oxide at baseline and 12 weeks 7. Inflammatory bowel disease quality of life scale at baseline and 12 weeks Previous secondary outcome measures: 1. Mayo Activity Index, assessed at baseline and 12 weeks 2. Traditional Chinese Medicine syndromes of UC score, assessed at baseline,4,8 and 12weeks 3. Fecal occult blood test, erythrocyte sedimentation rate, C-reactive protein, fecal calprotectin at baseline and 12weeks 4. Detection of intestinal apoptosis at baseline and 12 weeks 5. Detection of intestinal flora at baseline and 12 weeks 6. Detection of intestinal nitric oxide at baseline and 12 weeks 7. Inflammatory bowel disease quality of life scale at baseline and 12 weeks | — |
Countries
China
Outcome results
None listed