Functional constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Meet the diagnostic criteria for functional constipation according to Rome IV; 2.Meet the diagnostic criteria for constipation of Qi stagnation type in traditional Chinese medicine (TCM) pattern differentiation; 3.Patients possess the ability to comprehend and answer questions, with no communication barriers; 4.Participants fully understand the purpose, nature, procedures, and potential adverse reactions of the study, agree to comply with all study requirements, voluntarily join the study, and sign the informed consent form before the initiation of any study procedures.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Organic diseases of the digestive tract: tumors, inflammatory bowel disease (IBD), intestinal stenosis, outlet obstruction, etc.; 2. Pelvic floor dysfunction or rectal-anal coordination abnormalities: functional defecation disorders, outlet obstruction-type constipation; 3. Metabolic/endocrine disorders: thyroid dysfunction (hypothyroidism), diabetic neuropathy, electrolyte imbalances (e.g., hypokalemia); 4. Individuals with an allergic constitution; 5. Individuals who have used constipation treatment drugs or other medications affecting intestinal function (such as opioids, antidepressants, calcium supplements, etc.) within the recent period (within two weeks); 6. Individuals with abdominal conditions that clearly indicate a need for surgical intervention; 7. Individuals with abdominal wounds, skin damage, or other conditions unsuitable for local abdominal drug intervention; 8. Individuals concurrently participating in other drug clinical studies or unable to provide complete data, which may affect the efficacy assessment of this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wexner Constipation Score, WCS;Bristol Stool Form Scale (BSFS) score;TCM Syndrome Score;Fecal microbiota composition and a/ß diversity;Serum 5-HT concentratio;Serum SP concentration;Serum VIP concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Metabolomic Profile;Patient Assessment of Constipation Quality of Life (PAC-QOL) score;Safety outcome measure (AEs and ADRs); | — |
Countries
China
Contacts
Xiangya Hospital of Central South University