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Clinical efficacy of Painful Diarrhea Essentials Formula in the treatment of remission-phase ulcerative colitis with overlapping irritable bowel syndrome-like symptoms: a multicenter prospective real-world controlled study

Clinical efficacy of Painful Diarrhea Essentials Formula in the treatment of remission-phase ulcerative colitis with overlapping irritable bowel syndrome-like symptoms: a multicenter prospective real-world controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000496
Enrollment
Unknown
Registered
2025-03-10
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

ulcerative colitis

Interventions

Tong-Xie-Yao-Fang Group:Normal diet + Maintenance of original UC treatment drugs + Tong-Xie-Yao-Fang
Low FODMAP diet group:Low FODMAP diet + maintenance of original UC treatment drugs

Sponsors

The Third Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Consistent with the TCM syndrome of liver depression and spleen deficiency; (2) Compatible with UC patients in clinical remission; (3) Age 12-75 years old gender is not limited; (4) Diagnosis of IBS in accordance with Rome IV criteria; (5) Those who signed the informed consent form and could cooperate to complete the trial (for patients aged <18 years written informed consent was also obtained from both parents).

Exclusion criteria

Exclusion criteria: (1) Patients with concomitant organic gastrointestinal abnormalities other than UC, patients with intestinal stenosis, and patients with UC who had undergone more than one previous gastrointestinal surgery; (2) Patients with significant co-morbidities (e.g., malignant tumors, unstable cardiovascular disease) were excluded; (3) Patients who have participated in other clinical trials in the last 3 months; (4) Patients with psychiatric disorders that are not well controlled; (5) Vegetarians or people with intolerance to foods such as lactose, people with severe food intolerance, or people who cannot accept the low FODMAP diet prescribed in this study due to religious beliefs, etc.; (6) People who are not on the FODMAP diet. (6) Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Chinese Medicine Symptom Score;IBS-SSS Symptom Score;

Secondary

MeasureTime frame
CRP;GAD-7;Visceral Sensitivity Index;IBD-Q;Improved Mayo score;ESR;PHQ-9;fecal calprotectin;

Countries

china

Contacts

Public ContactShanShan Gong

The Third Affiliated Hospital of Zhejiang Chinese Medical University

2429902139@qq.com15757125250

Outcome results

None listed

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