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Investigating the Mechanism of TongXie YaoFang in Reducing Visceral Hypersensitivity in IBS-D via the "Clostridium Butyricum-Secondary Bile Acid-FXR/NGF/TRPV1" Axis from the Perspective of "Spleen Deficiency Leading to Diarrhea and Engendering Wind"

Investigating the Mechanism of TongXie YaoFang in Reducing Visceral Hypersensitivity in IBS-D via the "Clostridium Butyricum-Secondary Bile Acid-FXR/NGF/TRPV1" Axis from the Perspective of "Spleen Deficiency Leading to Diarrhea and Engendering Wind"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001614
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Diarrhea-predominant irritable bowel syndrome

Interventions

observe group:Tongxie Yaofang granules, 3 times daily, orally for 4 weeks.

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meeting both the Western medicine diagnostic criteria for IBS-D and the traditional Chinese medicine (TCM) diagnostic criteria for liver stagnation and spleen deficiency syndrome; (2) A baseline Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score >75; (3) Aged between 18 and 65 years (including 18 and 65 years) with no restriction on gender; (4) Willing to receive and able to comply with the treatment protocol and has signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) IBS subtypes other than IBS-D; patients with infectious diarrhea inflammatory bowel disease colorectal tumors or other organic gastrointestinal diseases will be excluded; (2) Patients with diabetes hyperthyroidism or uncontrolled hypertension; patients with severe primary diseases of major organs; those with abnormal liver or kidney function (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels greater than 1.5 times the upper limit of normal; creatinine [Cr] levels above the upper limit of normal); or clinically significant electrocardiogram (ECG) abnormalities; (3) Patients with neurological diseases a history of psychiatric disorders or poor compliance; (4) Individuals with allergic constitutions a history of severe drug allergies or severe food allergies; (5) Patients with a history of gastrointestinal surgery (excluding cesarean section and appendectomy); (6) Pregnant or lactating women or those planning to become pregnant in the near future; (7) Patients who have participated in other clinical trials within the past month; (8) Patients deemed unsuitable for inclusion by the investigators.

Design outcomes

Primary

MeasureTime frame
visceral sensitivity;

Secondary

MeasureTime frame
Bile acid metabolism;Inflammatory factors and neurotrophic factors;Irritable Bowel Syndrome-Quality of Life Measure;Irritable Bowel Syndrome symptom severity scale;Defecation situation;Anxiety and Depression Assessment;Intestinal flora;Farnesoid X Receptor/Nerve growth factor/Transient receptor potential vanilloid subfamily 1 signaling pathway;

Countries

China

Contacts

Public ContactFeng Peimin

Hospital of Chengdu University of Traditional Chinese Medicine

fpmvv@126.com18981885791

Outcome results

None listed

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