Condition category
Urological and Genital Diseases
Date applied
24/01/2011
Date assigned
18/03/2011
Last edited
18/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Albert Chang

ORCID ID

Contact details

16300 Sand Canyon Avenue
Suite 910
Irvine
California
92618
United States of America
+1 949 585 9870
shadycanyon@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3604-001

Study information

Scientific title

Clinical dosage and effectiveness study of ShanStar® Cranberry supplement for prevention and treatment against women's urinary tract infections: a double blind, randomised, placebo-controlled clinical study

Acronym

SSCPTUTI

Study hypothesis

This study explores the effectiveness of ShanStar® Cranberry extract against recurrent urinary tract infections in women on the basis of symptoms, bacteriuria and pyuria in the urine and urine culture.

Ethics approval

This study is to be conducted according to US and International standards of Good Clinical Practice and IRB guidelines, approved on 27/01/2011

Study design

Double blind randomised placebo-controlled clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urinary tract infection

Intervention

ShanStar® Cranberry extract 150mg and 300mg per day. Participants in each group are given pills - 3 months supply. Participants are instructed to take one tablet twice a day by mouth for 3 months. At 1, 2 and final 3 months follow up, they will score the urinary tract infection (UTI) symptoms and provide urine for complete urine analysis and urine culture. Total duration of the treatment will be 3 months.

Intervention type

Drug

Phase

Not Specified

Drug names

ShanStar® Cranberry extract

Primary outcome measures

At 1, 2, and 3 months, the participants will return to answer urinary tract symptoms questions and provide urine for complete urialysis and culture.
Primary outcome measures are:
1. Decrease in urinary tract infection symptoms score and decreased bacteriruia and pyuria and culture in urine study

Secondary outcome measures

No secondary outcome measures

Overall trial start date

31/01/2011

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between the age of 18-50
2. Female gender
3. Healthy individual with 3 or more episodes of urinary tract infections per year
4. Able to complete the research study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Terminal diesease or dementia
2. Abstain from any cranberry, health food fruit extracts, anti-oxidants, vitamins, minerals and antibiotics for 2 weeks prior to participation in the study
3. Pregnancy
4. Urine catherisation within previous 2 weeks of study
5. Participants with history of diabetes, cardiovascular disease, symptoms of pyelonephritis and stones in the urinary tract
6. Sexually transmitted disease
7. Pyuria or bacteriuria on urinalysis or positive urine culture ( will be treated and wait 2 weeks to be eligible)

Recruitment start date

31/01/2011

Recruitment end date

30/04/2011

Locations

Countries of recruitment

United States of America

Trial participating centre

16300 Sand Canyon Avenue
Irvine, California
92618
United States of America

Sponsor information

Organisation

ShanStar Biotech, Inc.

Sponsor details

1 Cliffstar Avenue
Dunkirk
NY
14048
United States of America
+1 716 363 3154
shanstarcustserv@cliffstar.com

Sponsor type

Industry

Website

http://shanstar.com/

Funders

Funder type

Industry

Funder name

ShanStar Biotech, Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes