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Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials

Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048502
Enrollment
Unknown
Registered
2021-07-09
Start date
2021-07-15
Completion date
Unknown
Last updated
2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. (1) Patients in remission who meet the diagnostic criteria for UC; (2) The classification belongs to E2 or E3 type, that is, the lesion range is sigmoid colon type, or sigmoid colon type combined with rectal type; (3) Meet the diagnostic criteria of TCM syndrome of spleen deficiency and dampness accumulation. 2. Aged 18 to 75 years old; 3. Patients who signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Active UC patients, severe UC patients who need systemic hormones (intravenous or oral); the classification belongs to E1 type, that is, the lesions are patients with pure rectal type; 2. Bacillary dysentery, amoebic dysentery, chronic schistosomiasis, intestinal tuberculosis and other infectious colitis and Crohn's disease, ischemic enteritis, radiation enteritis patients; colon cancer, rectal cancer patients; 3. Patients with severe complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal adenoma, toxic colonic dilatation, and anal disease; 4. Pregnant or lactating women; 5. Allergic constitution or allergic history to multiple drugs (more than 2 kinds or known ingredients in the prescription), allergic to aminosalicylic acid drugs; 6. Have serious primary cardiovascular, respiratory and blood system diseases; 7. Serum creatinine (Cr) is higher than the upper limit of the normal value, and liver function alanine aminotransferase (ALT) is more than 2 times the normal value; 8. Male patients with fertility requirements; 9. Patients who participated in clinical trials of other drugs within 3 months; 10. Other conditions that the doctor considers inappropriate as a subject.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Scale;The Short Inflammatory Bowel Disease Questionnaire (SIBDQ);The Short Health Scale ;The Rating Form of IBD Patient Concerns ;

Countries

China

Contacts

Public ContactHou Jiangtao

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

houjiangtao0128@163.com+86 20 36590032

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026