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Clinical and Experimental Study on Shunwei Jiangni Granules in the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome Based on the "Gut-Brain Axis" (Clinical Research Section)

Clinical and Experimental Study on Shunwei Jiangni Granules in the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome Based on the "Gut-Brain Axis" (Clinical Research Section)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000103
Enrollment
Unknown
Registered
2026-01-17
Start date
2025-04-22
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Irritable Bowel Syndrome

Interventions

Control group2:Taking trimebutine Maleate Capsules and deanxit
Treatment group:Taking Shunwei Jiangni Granules
Control group1:Taking deanxit

Sponsors

Affiliated Hospital of Shanxi University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meeting the diagnostic criteria for IBS in the Consensus on Integrative Medicine Diagnosis and Treatment of Irritable Bowel Syndrome (2017) with the TCM syndrome type being cold-heat mixed syndrome; (2) Exclusion of intestinal organic lesions by colonoscopy; (3) Aged 18–65 years; (4) No administration of IBS treatment drugs in the past month; (5) No history of abdominal surgery; (6) Hamilton Depression Scale score =7 and =17 Hamilton Anxiety Scale score =7 and =14; (7) Informed about the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Aged 65 years; (2) Constipation-predominant IBS mixed IBS or unsubtyped IBS; (3) Diarrhea caused by tumors bacterial/viral infections poisoning etc.; (4) Participation in other clinical trials or allergy/intolerance to the study drugs; (5) Use of drugs affecting intestinal function or pain within the past month; (6) Pregnant or lactating women; (7) Comorbid mental disorders inflammatory bowel disease or severe cardiovascular hepatic renal or cerebrovascular diseases; (8) Refusal of traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
Serum levels of CRH, ACTH, and cortisol;Serum brain-gut peptide levels (VIP 5-HT SP BDNF);

Secondary

MeasureTime frame
Traditional Chinese Medicine (TCM) syndrome scores;Overall symptom evaluation;Single symptom evaluation;

Countries

China

Contacts

Public Contactlipeifang

Affiliated Hospital of Shanxi University of Chinese Medicine

fangfang444@163.com15235181143

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026