functional constipation
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| gut microbiota;Metabolomics;immunity index;SBM;wenger constipation Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| IL-17 IL-18 IL-4/IL-1;TNF-a;CD3 CD4/CD8;SIgA; | — |
Countries
China
Contacts
Weifang People's Hospital