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IBS-D Prognosis and Xu's Yigan Fupi Formula Treatment Prediction Based on Multi-omics: A Real-World Cohort Study.

IBS-D Prognosis and Xu's Yigan Fupi Formula Treatment Prediction Based on Multi-omics: A Real-World Cohort Study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000275
Enrollment
Unknown
Registered
2024-08-20
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Irritable Bowel Syndrome with Predominant Diarrhea

Interventions

Unexposed group:Other treatments except for Xu's Yigan Fupi Formula, including gastrointestinal antispasmodics, microecological regulators, etc.
Exposed group:Xu's Yigan Fupi Formula

Sponsors

Affiliated Hospital of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Those who meet the diagnostic criteria of IBS-D and the syndrome differentiation criteria of Liver depression and Spleen deficiency syndrome in traditional Chinese medicine. 2.Age between 18~65 years old, gender is not limited. 3. Informed consent, voluntary participation. The process of obtaining informed consent should be in accordance with GCP regulations.

Exclusion criteria

Exclusion criteria: 1. Those who cannot cooperate with clinical data collection. 2. Pregnant and lactating women. 3. Have serious primary diseases in various systems or or serious diseases that affect their survival, such as malignant tumors, heart failure, acute stroke, severe liver and kidney insufficiency, etc. 4. Those who are unable to give full informed consent due to intellectual or behavioral disabilities. 5. Suspected or confirmed history of alcohol and drug abuse. 6. According to the judgment of the investigator, other lesions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, and other conditions that are easy to cause loss of follow-up. 7. Allergies, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of the formula being studied.

Design outcomes

Primary

MeasureTime frame
Score of symptoms and signs in traditional Chinese medicine;'relapse' or 'relapse-free';Bristol score;

Secondary

MeasureTime frame
SAS, SDS;IBS-SSS;IBS-QOL;

Countries

China

Contacts

Public ContactWeimin Lu

Affiliated Hospital of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine

wmlu@163.com+86 137 0158 0011

Outcome results

None listed

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