Ulerative Colitis
Conditions
Interventions
MZWD CDD-2103 group:MZWD CDD-2103 Gao Fang, two packs/day, twice daily for 24 weeks
Placebo group:Placebo, two packs/day, twice daily for 24 weeks
Sponsors
Hong Kong Baptist University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients eligible for the trial must comply with all of the following at randomization: 1. Aged 18-65 years. 2. The diagnostic criteria for clinical remission of UC at least 3 months prior to study entry. Clinical remission is defined as Mayo score of less than or equal to 2 with no individual subscore greater than 1. 3. The diagnostic criteria for spleen deficiency with dampness obstruction, which can be diagnosed on the basis of any two main symptoms and two secondary symptoms, with reference to the tongue and pulse, as follows: main symptoms include loose stool (with mucus or not); diarrhea and loose stool with undigested food; and distended abdomen. Secondary symptoms include abdominal vague pain; physical fatigue and heavy; poor appetite or anorexia; and mental fatigue and lazy talk. Light red tongue with edge teeth marks and thin white greasy coasting; as well as thready and weak pulse or thready and slippery pulse. 4. Normal liver and renal function in blood test within 3 months. 5. Individuals should fully understand what is involved in this study and give documented consent to participate in the study.
Exclusion criteria
Exclusion criteria: Patients who meet one of the following criteria will be excluded: 1. The presence of active UC within 90 days before eligibility determination. 2. Abnormal colonoscopy and biopsy pathology report, such as crypt epithelial dysplasia (intraepithelial neoplasia) or cancerous. 3. Intestinal stenosis. 4. Infectious enteritis or any suspicion of the presence of infectious enteritis (e.g., present of positive in the clostridium difficile test). 5. Individual who has been taken biological drugs or antibiotics within the last three months. 6. Aparotomy or laparoscropic surgery, surgery for hemorrhoids or perianal abscess, endoscopic mucosal resection or endoscropic intestinal dilation or endoscopic intestinal dilatation of the colon within 60 days before eligibility determination. 7. History of resection of the small intestine, cecum, colon or rectum. 8. Individuals with moderate or severe hepatic or renal disease abnormalities. 9. Individuals with any serious comorbid disease, such as hematological, respiratory, cardiovascular, or neuropsychiatric disease, or metabolic/electrolyte abnormality. 10. Individuals undergoing treatment or follow-up under 5 years for a malignant tumor. 11. History of allergy to Chinese herbal medicine (e.g., G6PD deficiency). 12. History of alcohol or drug abuse. 13. Pregnant and nursing women and women suspected of being pregnant. 14. Individuals who are participating in any other clinical researches at study entry. 15. Others whom the investigator or co-investigator considered to be inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nonrecurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial Mayo Score;IBD questionnaire (IBDQ);Simple clinical colitis activity index (SCCAI);TCM syndrome scale; | — |
Countries
China
Contacts
Public ContactZhaoxiang Bian
Hong Kong Baptist University
Outcome results
None listed