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Comparative Study of Different Dosages of Vibrabot Capsule in the Treatment of Chronic Functional Constipation

NCT06526767 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-07-30

No results posted yet for this study

Summary

This is a single-center trial that enrolls 120 18- to 85-year-old patients with mild to moderate chronic functional constipation to study the dose-response relationship of the Vibrabot capsule as well as the mechanism of action of the Vibrabot capsule.

Conditions

  • Chronic Functional Constipation

Interventions

DEVICE

Vibrabot capsules twice a week

Subjects in control group took Vibrabot capsules twice a week, one pill/time (on Monday and Thursday), for six weeks.

DEVICE

Vibrabot capsules three times a week

Subjects in trial group 1 took Vibrabot capsules three times a week, one pill/time (Monday, Wednesday, and Friday) for six consecutive weeks.

DEVICE

Vibrabot capsules five times a week

Subjects in trial group 2 took Vibrabot capsules five times a week, one pill/time (Monday, Tuesday, Wednesday, Friday, and Saturday), for six weeks.

DEVICE

Vibrabot capsules loading dose

Subjects in trial group 3 took Vibrabot capsules one pill/time, five times a week (Monday, Tuesday, Wednesday, Friday, and Saturday) during the first two weeks, three times a week (Monday, Wednesday, and Friday) during the middle two weeks, and two times a week (Monday and Thursday) during the last two weeks.

Sponsors & Collaborators

  • Beijing Tsinghua Chang Gung Hospital

    lead OTHER

Principal Investigators

  • Xuan Jiang, Professor · Beijing Tsinghua Changung Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06526767 on ClinicalTrials.gov