Chronic Constipation
Conditions
Keywords
Vibrating Capsule, Efficacy and Safety, Chronic Constipation, different vibrating modes
Brief summary
Constipated patients in the participating center from February 2017 to June 2018 (anticipated) were prospectively enrolled. Number of defecation per week，Bristol score，and Colon transmission experiment were compared with the constipated patients before treatment.
Detailed description
Constipation affects the quality of life of patients, some patients abuse laxatives or repeated medical treatment, increased medical costs. At present, the main treatment of constipation is to adjust life style, medicine, psychotherapy, biofeedback and surgical treatment. However, the above methods are associated with adverse reactions, and the patient's satisfaction is still low. A new approach is needed to solve this clinical problem. Investigators have developed a vibration capsule that can be adjusted in different modes. Preliminary animal experiments showed that the capsule was safe and increased the number of defecation. This study is a clinical research for patients with constipation, to explore the effect in different vibrating modes in patients with constipation and tract emptying transmission and its effectiveness.
Interventions
DEVICESham Capsule
Capsules can't vibrate but look the same as Vibrating Capsule
DEVICEVibrating Capsule
Patients in this group would be treated with Vibrating Capsule
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged form 18 to 80 * Clinical diagnosis of functional constipation * Must be able to swallow vibrating capsule
Exclusion criteria
* complex history of gastrointestinal diverticula, obstruction, ulcer, bleeding, stenosis or fistula. * recent use of banned drugs. * patients who are preparing for mri.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| defecation frequency | 8 weeks | the average weekly defecation frequency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bristol Stool Chart | 8 weeks | Record the BSC of each defecation. |
| first defecation | 8 weeks | The time of complete defecation after taking the capsule for the first time |
Countries
China
Outcome results
None listed