Herbal Patch for Overactive Bladder | NCT03532789

Studies
Herbal Patch for Overactive Bladder

NCT03532789

Sponsor

En Chu Kong Hospital

Status

Completed

Last Update Posted

Oct 25, 2019Actual

Enrollment

66Actual

Phase

Phase 2Phase 3

Conditions

Overactive Bladder Syndrome

Interventions

herbal patch
placebo patch

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 14, 2018Actual

Primary Completion Date

Oct 23, 2019Actual

Completion Date

Oct 23, 2019Actual

First Submitted Date

May 8, 2018

First Submission Date that Met QC Criteria

May 21, 2018

First Posted Date

May 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2019

Last Update Posted Date

Oct 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

LIH-LIAN Chen, Attending physician of department of Traditional Chinese medicine, En Chu Kong HospitalPrincipal Investigator

Lead Sponsor

En Chu Kong HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
herbal patch group	Experimental	using herbal patch as an intervention	Drug: herbal patch
placebo patch group	Placebo Comparator	using placebo patch as an intervention	Drug: placebo patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
herbal patch	Drug	One patch with medicine should be applied to the skin every other day within two weeks	herbal patch group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OABSS	Overactive bladder symptom score, questionnaire	Change from Baseline OABSS at 2weeks

Secondary Outcomes

Measure	Description	Time Frame
PPBC	Patient perception of bladder condition, questionnaire	Change from Baseline PPBC at 2weeks
USS	Urgency Severity Scale, questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
LIH-LIAN CHEN, MD	attending physician of department of Traditional Chinese medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EnChuKong hospital		New Taipei City	Sanxia Dist	237	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

primary and secondary outcome of this study

Types

Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

information sharing after paper published

Access Criteria

all in public, without any kind of review

URL

Not provided