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This is a single-center trial. It enrolled nine 18- to 85-year-old patients with chronic constipation to evaluate the efficacy of long-course treatment by using vibrating capsule (VC).
This study was a single-center prospective, single-arm exploratory clinical trial. If a subject signs an Ethics Committee (EC)-approved study informed consent (ICF) that meets the inclusion criteria and does not meet any of the exclusion criteria, the subject is considered eligible for admission to the study.
After completing a baseline questionnaire on bowel movements over the most recent 2 weeks, participants took VC at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. After completion of treatment, subjects entered a follow-up period for at least 8 weeks. During the study period, the subjects are required to keep an e-diary recording daily bowel movements (BMs), medication intake, and discomforts, and complete the Patient Assessment of Constipation Symptoms (PAC-SYM) and the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires every two weeks.
Subjects are not expected to change their diet or lifestyle during the study. If the subject has not had a bowel movement for three or more consecutive days, the subject is allowed to use another method of defecation to assist with defecation. Subjects are required to avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial group | Experimental | Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treat with Vibrabot capsules for at least 7 weeks | Drug | Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportions of responders during the treatment period. | Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the treatment period compared to the baseline period. | at least 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period. | Evaluating the proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period. | at least 7 weeks |
| Number of mean weekly complete spontaneous bowel movements (CSBM). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuan Jiang, Professor | Beijing Tsinghua Changung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XuanJiang | Beijing | Beijing Municipality | 102218 | China |
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| ID | Term |
|---|---|
| D003033 | Coal Tar |
| ID | Term |
|---|---|
| D013638 | Tars |
| D045424 | Complex Mixtures |
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The average number of complete spontaneous bowel movements per week for each patient during the treatment period. |
| at least 7 weeks |