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
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