Functional constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Meeting the Rome IV diagnostic criteria for functional constipation; 2)Aged 18–70 years, with no restriction on gender; 3)Having not taken any drugs related to the treatment of this disease for at least one week before enrollment in the study, and having not participated in any other ongoing studies; 4)Having undergone a colonoscopy within 1 year (to rule out organic lesions such as colonic polyps and inflammatory bowel disease); 5)Voluntarily participating in the study and signing the informed consent form in person; 6)Having a permanent residence in the location where the treatment is provided, which is conducive to treatment and follow-up. Only patients who meet all the above criteria (1–6) can be included in this study. For patients with alarm signs, targeted auxiliary examinations should be selected to rule out organic diseases. Alarm signs include hematochezia, positive fecal occult blood test, thin stool, anemia, weight loss, obvious abdominal pain, abdominal mass, history of colorectal polyps, and family history of colorectal cancer.
Exclusion criteria
Exclusion criteria: 1) Organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tumors, tuberculous peritonitis, chronic pancreatitis, etc., or patients currently complicated with peptic ulcer or infectious diarrhea; 2)Drug-induced constipation; 3)Irritable bowel syndrome; 4)Diseases affecting digestive system function, such as uncontrolled hyperthyroidism or hypothyroidism, diabetes mellitus, autoimmune diseases, neurological diseases (e.g., anorexia nervosa, etc.) or severe mental system diseases (e.g., major depression or severe anxiety); 5)Severe heart, liver, kidney diseases, cerebrovascular diseases, hematopoietic system diseases, or tumors; 6)A history of gastrointestinal surgery; 7)Suspected or confirmed history of tobacco, alcohol, or drug abuse; 8)Inability to discontinue or planned use of drugs affecting gastrointestinal motility and function during the study period, such as prokinetic agents, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheals, antacids, antidepressants, anxiolytics, intestinal flora modulators, and antibiotics; 9)Female subjects who are pregnant, lactating, or planning to become pregnant during the study period; 10)Subjects who have participated in any clinical trial and received treatment within the past 3 months; 11)Other circumstances deemed by the researcher to make the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Spontaneous Complete Bowel Movements per Week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool Consistency;Severity of Abdominal Pain and Bloating;Degree of Defecatory Effort;Sensation of Incomplete Defecation;Quality of Life in Constipated Patients;Anxiety / Depression;Vasoactive Intestinal Peptide (VIP), Serum 5-Hydroxytryptamine (5-HT), Substance P (SP); | — |
Countries
China
Contacts
Suining Central Hospital