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Clinical Study on the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome with Liver Depression and Spleen Deficiency Syndrome by Rougan Jianpi Formula

Inheritance of Professor Wen Yandong's Academic Thought and Clinical Experience in Treating Spleen and Stomach Diseases---Clinical Study on the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome with Liver Depression and Spleen Deficiency Syndrome by Rougan Jianpi Formula

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000941
Enrollment
Unknown
Registered
2025-05-09
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

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

Test group:Rougan Jianpi Formula made into granules twice a day 2 bags each time
Control group:Placebo made into granules twice a day 2 bags each time

Sponsors

Eye Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients who fulfill the diagnostic criteria for IBS-D according to Rome IV and ICD-10 as well as Liver Depression and Spleen Deficiency Syndrome based on TCM syndrome differentiation. (2) Patients whose age between 18 and 70 years old (inclusive). (3) Patients who not currently participating in other clinical trials. (4) Patients with no use of antidiarrheal drugs antibiotics or other medications that may interfere with the study outcomes within 30 days prior to enrollment. (5) Patietns voluntarily agree to participate in and cooperate with the trial as well as sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Patients with diarrhea caused by other diseases such as infectious diarrhea inflammatory bowel disease hyperthyroidism malignancies diabetes mellitus etc. (2)Patients whose age 70 years old. (3)Patients with severe comorbid conditions affecting vital organs (e.g. respiratory cardiovascular or digestive systems). (4)Patients with history of abdominal or rectal/anal surgery. (5)Patients who participated in other clinical trials within 3 months prior to enrollment. (6)Inability to communicate normally or presence of psychiatric disorders or non-compliance with treatment. (7)Patients who are planning pregnancy currently pregnant or breastfeeding. (8)patients with history of alcohol abuse drug/substance dependence or illicit drug use.

Design outcomes

Primary

MeasureTime frame
Assessment of abdominal pain intensity;Changes in defecation characteristics;—

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Points for Diarrhea;Hamilton Depression Scale score;Hamilton Anxiety Scale score;Severity score of irritable bowel syndrome;Quality of Life Score for Irritable Bowel Syndrome ;—

Countries

China

Contacts

Public ContactSU FU

Eye Hospital China Academy of Chinese Medical Sciences

fpianpian@live.cn13810973741

Outcome results

None listed

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