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Exploring the mechanism of Buzhong Yiqi Decoction in treating chronic functional constipation through regulating intestinal immune infiltration based on gut microbiota and metabolomics

Exploring the mechanism of Buzhong Yiqi Decoction in treating chronic functional constipation through regulating intestinal immune infiltration based on gut microbiota and metabolomics

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075882
Enrollment
Unknown
Registered
2023-09-19
Start date
2023-09-19
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

functional constipation

Interventions

The experimental group:Buzhong Yiqi Decoction

Sponsors

Weifang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: a) Age =18 years, regardless of gender; b) Western medical diagnosis criteria: diagnosed with chronic functional constipation according to the 2016 functional gastrointestinal disorders (FCIDS)-Rome IV criteria, and TCM syndrome differentiation criteria: diagnosed with Qi Deficiency Constipation according to the "Consensus Opinion of Chinese Traditional Medicine Experts on the Diagnosis and Treatment of Constipation" issued by the Spleen and Stomach Diseases Branch of the Chinese Traditional Medicine Association in 2017; c) Those who have undergone relevant physical examination, laboratory tests, and imaging examination without any alarming symptoms; d) Patients who have not taken any drugs that affect the gut microbiota, gut motility, and/or stimulate laxatives or antibiotics within 1 week prior to treatment; e) Discontinue use of other traditional Chinese medicine formulas, and have a stable condition for 4 weeks or more; f) Those whose laboratory test results at the screening stage indicate that the subjects have sufficient organ function; g) Voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion criteria: a) Patients with constipation caused by organic diseases; b) Patients with chronic constipation and anorectal diseases who have surgical indications; c) Patients with secondary constipation with clear causes; d) Patients with digestive system diseases, or those with serious circulatory, respiratory, endocrine, and other systemic diseases; e) Patients who have undergone acute gastrointestinal diseases or surgery within the past 30 days; f) Women who are pregnant or breastfeeding; g) Long-term users of antipsychotic drugs.

Design outcomes

Primary

MeasureTime frame
gut microbiota;Metabolomics;immunity index;SBM;wenger constipation Score;

Secondary

MeasureTime frame
IL-17 IL-18 IL-4/IL-1;TNF-a;CD3 CD4/CD8;SIgA;

Countries

China

Contacts

Public ContactYuying Zhang

Weifang People's Hospital

wfzzbzy@126.com+86 139 6368 8595

Outcome results

None listed

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