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Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials

Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002423
Enrollment
Unknown
Registered
2019-06-24
Start date
2019-08-01
Completion date
Unknown
Last updated
2023-02-20

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. patients with UC in the remission phase (determined by a UC Disease Activity Index score of 0–2 and bloody stool score of 0); the extent of UC is limited to left sided colitis and extensive colitis (Montreal classificati on E2, E3); the TCM syndrome was dampness stagnancy due to spleen deficiency syndrome; 2. men or women aged between 18 and 75 years; 3. participants voluntarily participated in this study, signed informed consent, and had good compliance.

Exclusion criteria

Exclusion criteria: 1. patients with active UC, severe UC, or acute fulminating type UC; 2. patients undergoing treatment with corticosteroids (oral, enemas, suppository, injectable solution); 3. patients treated with blood cell apheresis; 4. patients who were administered anti-tumor necrosis factor-a antibody within 90 days before starting the study drug; 5. patients with history of hypersensitivity to mesalazine and salicylic acid; 6. patients with serious cardiovascular disease, hemodyscrasia, or lung disease or with a history of these conditions; 7. patients with liver disease or kidney disease; 8. patients with malignant tumor as a complication; 9. pregnant women or those who were breastfeeding; 10. other conditions that the researcher don't consider it was suitable.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale (diarrhea, abdominal pain, mucus stool, bloody purulent stool);

Secondary

MeasureTime frame
TCM Syndrome Scale;The Short Inflammatory Bowel Disease Questionnaire (SIBDQ);The Short Health Scale (SHS);The Rating Form of IBD Patient Concerns (RFIPC);

Countries

China

Contacts

Public ContactLiu Fengbin

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

liufb163@163.com+86 020 36590032

Outcome results

None listed

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