Chronic functional constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this trial: (1) Meet the diagnostic criteria for functional constipation; (2) Average weekly CSBMs = 2 times and weekly SBMs = 2 times in the past 3 months; (3) No gender restrictions, age between 18 = age = 75 years old; (4) Patients over 50 years old or presenting with the following alarm symptoms and signs must provide normal colonoscopy results from a tertiary hospital within the past 3 months: lower gastrointestinal bleeding (hematochezia, melena, positive fecal occult blood test), anemia, unexplained weight loss (weight loss >10% in 3 months), abdominal mass, significant abdominal pain, history of colonic polyps, family history of colorectal cancer, or sudden change in intestinal symptoms; (5) Have not used any constipation medications in the past 2 weeks prior to treatment (except for emergency treatment), have not received acupuncture therapy for constipation in the past month, and are not participating in any other ongoing clinical studies; (6) Sign the informed consent form and voluntarily participate in this study.
Exclusion criteria
Exclusion criteria: Subjects with any of the following cannot be enrolled in this study: (1) Irritable Bowel Syndrome (IBS) and organic constipation (e.g., gastrointestinal obstruction) or drug-induced constipation; constipation secondary to endocrine, metabolic, neurological, or surgical conditions (e.g., gastrointestinal surgery); (2) During spontaneous bowel movements without the use of laxatives at baseline, the occurrence of more than one episode of pudding-like or watery stools (as per the Bristol Stool Form Scale types 6 and 7); (3) History of pelvic floor dysfunction; (4) Currently taking medications that affect intestinal function or can cause constipation (however, medications for other conditions that may impact efficacy assessment are permitted during the trial, but must be truthfully recorded and analyzed); (5) Severe hemorrhoids or anal fissures; (6) Concurrent severe or uncontrolled cardiovascular, hepatic, or renal impairment; abdominal aortic aneurysm; hepatosplenomegaly; cognitive dysfunction; aphasia; mental disorders; or inability to comply with examinations and treatments; (7) Pregnant or breastfeeding patients; (8) Bleeding disorders or long-term use of anticoagulants such as warfarin or heparin; (9) Patients with pacemakers installed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of cases where CSBMs =3 in the last week of the treatment period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of cases with CSBMs = 3 times per week on average during the treatment and follow-up periods.;Bristol Stool Scale;Severity of difficulty in defecation;Constipation Patients' Symptom Self-Assessment Scale;Constipation Patients' Quality of Life Self-Rating Scale;Overall Effectiveness Evaluation;Acupuncture Expectation Value Evaluation;Acupuncture Acceptance Evaluation;Compliance Evaluation;Safety Evaluation; | — |
Countries
China
Contacts
Hunan University of Traditional Chinese Medicine