Health Condition 1: N399- Disorder of urinary system, unspecified
Conditions
Interventions
Intervention1: IND 1-A (Active) Blends of strains VHBSUB, VHBCSI, VHBAX: Each capsule contains Bacillus coagulans(3 billion),Bacillus clausii(1 billion),Bacillus subtilis(6 billion),billion cfu of eac
Sponsors
Vidya Herbs Pvt LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Post-menopausal women >12 months since their last menstrual period. Menopause may be natural or induced due to surgical or medical intervention. 2.Have a history of recurrent UTIs, defined as = 3 episodes in the past year, of which two were approximately in the past 6 months immediately prior to their screening visit (Visit 1), at the discretion of the investigator. At least one episode must be diagnosed medically and treated by a health care professional, the remaining two may be self-reported.
Exclusion criteria
Exclusion criteria: Patients with history or significant presence of the following will be excluded from participation or enrollment in the study trial: ?Immunosuppressed ?Known allergies to investigational product or its excipients ?Known vaginal infection other than bacterial vaginosis (BV) or yeast infection at time of screening ?Women who have needed changes to medical intervention or in-office procedures in the last 3 months ?Women who wear a pessary ?Women who use catheters regularly ?Women with an obstruction or neurogenic bladder causing incomplete bladder emptying. Individuals who have taken oral antibiotics (or topical antibiotics in their urogenital area) within the previous 30 days. ?Individuals that have a significant acute or chronic coexisting illness such as renal diseases (renal failure, nephrolithiasis), anatomical urinary tract abnormalities, intestinal disease, severe uncontrolled metabolic or cardiovascular disease (such as diabetes or hypertension), anticoagulant therapy, cancer. ?Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of symptomatic UTITimepoint: Screening and Enrollment visit. Visit 01(Day 01) Baseline Visit 02 (Day 14 ? 3 days) Assessment Visit iv.Visit 03 (Day 28 ? 3 days) Assessment visit Visit 04 Day 45 (Interim visit) Visit 05 (Day 56 ? 3 days) Assessment visit Visit 06 (Day 70 ? 3 days) Assessment visit (Day 90): End of Treatment Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Number of participants who Experienced at least one Adverse Event during the study duration ?Number of participants who discontinued study drug due to an Adverse Event during the study.Timepoint: ?Number of participants who Experienced at least one Adverse Event during the study duration ?Number of participants who discontinued study drug due to an Adverse Event during the study.One of both of these formulations will be administrated thrice a day for 12 consecutive weeks. | — |
Countries
India
Contacts
Public ContactDr Suman G
Rajalakshmi Hospital
Outcome results
None listed