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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Capsule | Sham Comparator | Patients swallowed 1 sham Vibrating capsule with water every three days,recorded his defecation time, defecation frequency and bristol score.The total capsule need to take 12. |
|
| Vibration Capsule of low level | Experimental | Patients swallowed 1 low level vibration Capsule Vibrating capsule with water every three days,recorded his defecation time, defecation frequency and bristol score.The total capsule need to take 12. |
|
| Vibration Capsule of high level | Experimental | Patients swallowed 1 high level vibration Capsule Vibrating capsule with water every three days,recorded his defecation time, defecation frequency and bristol score.The total capsule need to take 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrating Capsule | Device | Patients in this group would be treated with Vibrating Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| defecation frequency | the average weekly defecation frequency | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bristol Stool Chart | Record the BSC of each defecation. | 8 weeks |
| first defecation | The time of complete defecation after taking the capsule for the first time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28588191 | Result | Yu J, Qian YY, He CH, Zhu SG, Zhao AJ, Zhu QQ, Shao CW, Wang TG, Wang Y, Ding GL, Liao Z, Li ZS. Safety and Efficacy of a New Smartphone-controlled Vibrating Capsule on Defecation in Beagles. Sci Rep. 2017 Jun 6;7(1):2841. doi: 10.1038/s41598-017-02844-4. |
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We may share IPD when we finish this research
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| Sham Capsule | Device | Capsules can't vibrate but look the same as Vibrating Capsule |
|
| 8 weeks |