Herbal Patch for Overactive Bladder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-14

Study Completion Date

2019-10-23

Brief Summary

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Overactive bladder is a clinical syndrome characterized by frequency, with or without urge incontinence, urgency, and nocturia, which affect patients' sleeping quality and rehabilitation program progressing. Current treatments include behavioral therapy (eg, life style adjustment, bladder training, pelvic floor muscle therapy) and medication. Antimuscarinic agents is the most common medications prescribed for OAB, but patients often have side effects like dry mouth and constipation. And there were plenty of herbal medicine which are beneficial to urine frequency and voiding dysfunction in ancient Chinese medicine books and records. In human trial, 62 Subjects diagnosed as overactive bladder will be enrolled and treated with Cinnamon patch. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.

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Detailed Description

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Overactive bladder is a clinical syndrome characterized by frequency, with or without urge incontinence, urgency, and nocturia, which affect patients' sleeping quality and rehabilitation program progressing. Current treatments include behavioral therapy (eg, life style adjustment, bladder training, pelvic floor muscle therapy) and medication. Antimuscarinic agents is the most common medications prescribed for OAB, but patients often have side effects like dry mouth and constipation. And there were plenty of herbal medicine which are beneficial to urine frequency and voiding dysfunction in ancient Chinese medicine books and records. In human trial, 62 Subjects diagnosed as overactive bladder will be enrolled and treated with Cinnamon patch. After treatment we will estimate the efficacy and record adverse events to conduct statistically analysis.

The 1st year project: (1) Expect to enroll 62 clinical subjects of OAB. (2) Evaluate subjects 'symptom and proceed patch treatment. (3) Record treatment responses including adverse effect. (4) Conduct statistically analysis.

The 2nd year project: (1) Completing enrollment of 62 clinical subjects of OAB. (2) Finish evaluation and treatment of all subjects. (3) Statistically analysis all collecting data (4) Discuss and analyze the outcome.

Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

overactive bladder patients

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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herbal patch group

using herbal patch as an intervention

Group Type EXPERIMENTAL

herbal patch

Intervention Type DRUG

One patch with medicine should be applied to the skin every other day within two weeks

placebo patch group

using placebo patch as an intervention

Group Type PLACEBO_COMPARATOR

placebo patch

Intervention Type DRUG

One patch without medicine should be applied to the skin every other day within two weeks

Interventions

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herbal patch

One patch with medicine should be applied to the skin every other day within two weeks

Intervention Type DRUG

placebo patch

One patch without medicine should be applied to the skin every other day within two weeks

Intervention Type DRUG

Other Intervention Names

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OAB patch control patch

Eligibility Criteria

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Inclusion Criteria

* urgency score of OABSS ≥ 2 or total score of OABSS ≥ 3

Exclusion Criteria

* suffering from acute urinary tract infection
* recurrent urinary tract infection ≥ 5 times in the last year
* Hematuria or bladder stone disease
* using foley catheter
* Pregnant or breastfeeding women
* Spinal cord injury patients
* Mental illness or substance abuse
* taking medicine for the treatment of overactive bladder within one month

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No