Clinical dosage and effectiveness Study of ShanStar® Cranberry supplement for Prevention and Treatment against women's Urinary Tract Infections
| ISRCTN | ISRCTN55813586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55813586 |
| Secondary identifying numbers | 3604-001 |
- Submission date
- 24/01/2011
- Registration date
- 18/03/2011
- Last edited
- 18/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Albert Chang
Scientific
Scientific
16300 Sand Canyon Avenue
Suite 910
Irvine, California
92618
United States of America
| Phone | +1 949 585 9870 |
|---|---|
| shadycanyon@yahoo.com |
Study information
| Study design | Double blind randomised placebo-controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| 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(s) | This study is to be conducted according to US and International standards of Good Clinical Practice and IRB guidelines, approved on 27/01/2011 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | ShanStar® Cranberry extract |
| Primary outcome measure | 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 study start date | 31/01/2011 |
| Overall study end date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target number of participants | 60 |
| 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 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
Study participating centre
16300 Sand Canyon Avenue
Irvine, California
92618
United States of America
92618
United States of America
Sponsor information
ShanStar Biotech, Inc.
Industry
Industry
1 Cliffstar Avenue
Dunkirk, NY
14048
United States of America
| Phone | +1 716 363 3154 |
|---|---|
| shanstarcustserv@cliffstar.com | |
| Website | http://shanstar.com/ |
Funders
Funder type
Industry
ShanStar Biotech, Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
