Functional constipation in adults
Conditions
Interventions
Experimental group:Swallow vibrating capsules 2 times/week for a course of 4 weeks
Sponsors
Medical Ethics Committee of Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Study subjects should meet the following criteria: • Subjects must meet all of the following inclusion criteria: • 18= age= 70 years old, regardless of gender; • At least 2 of the following symptoms are included, (1) At least 25% of bowel movements are laborious (2) At least 25% of bowel movements are dry bulbous or hard stools (3) At least 25% of bowel movements are incomplete (4) At least 25% of bowel movements have anorectal obstruction/obstruction (5) At least 25% of bowel movements require manual assistance (e.g., finger defecation assistance, pelvic floor support) (6) The number of spontaneous bowel movements< 3 times/week The above symptoms have been present for at least 6 months, and the symptoms in the last 3 months meet the above diagnostic criteria. • Subjects receiving vibration capsules; • Able and willing to comply with the contraindications and restrictions set forth in the protocol; • Subject is willing and able to fill out questionnaires and diaries; • Subjects are able to receive follow-up during the trial phase as specified in the trial protocol; • Subject agrees to use contraception for the duration of the study; • Subjects understand the purpose and procedures of the trial and voluntarily participate in the study, voluntarily sign a written informed consent form. • Patients with no obvious organic lesions confirmed by colonoscopy in the past 3 years in hospitals above the second level;
Exclusion criteria
Exclusion criteria: Those who are allergic to barium; • Patients with permanent pacemaker (e.g., implantable cardioverter-defibrillator) or any electronic/magnetic/mechanical control device; • Dysphagia or gastric outlet obstruction; • Exclude pregnancy or lactation; • "alarm" symptoms in recent years, including abnormal weight loss (more than 10% in the last three months) • Drugs prohibited in this study (such as prokinetic drugs, intestinal lamients, antidepressants, drugs for the treatment of Parkinson's disease, opioids and other anesthetics, aluminum magnesium hydroxide, etc.) • Have severe cardiopulmonary and renal, diabetic, psychiatric diseases (such as pacemaker placement, cardiac stent placement, cardiac function grade III-IV requiring anti-heart failure therapy, diabetic gastroparesis, diabetic ketosis or ketoacidosis, hyperosmolar coma). Kidney failure, chronic asthma attack, chronic obstructive pulmonary disease attack, schizophrenia attack, or other serious psychiatric illness that is being controlled by medication) • Known or suspected organic lesions of the large intestine, i.e., obstructive, cancerous, or inflammatory diseases; • Known or suspected stricture, obstruction, diverticulum, perforation, bleeding, infection of the digestive tract; • Intestinal polyps or gastrointestinal ESD surgery within the past 3 months; • Participated in other interventional clinical trials in the past 3 months; • Other conditions judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SBM+1; | — |
Secondary
| Measure | Time frame |
|---|---|
| SBM+1;PCA- SYM;PAC-QOL;CSBM; | — |
Countries
China
Contacts
Public ContactYang Jie
Medical Ethics Committee of Affiliated Hospital of Guizhou Medical University
Outcome results
None listed