Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: VISPO, 500 mg capsule: Oral administration of single dose of VispoTM 500mg capsule every night for 84 days
Control Intervention1: 500 mg maltodextrin capsule: Oral administration of sin
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Women with frequent urination, nocturia, and/or urgency for at least 2 months 2.Urinary symptoms that do not require medical treatment based on definitions by physicians 3.Must be able to read and understand in English or local language and maintain a subject diary 4.Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1.Suspected to have overactive bladder (OAB) according to the core lower urinary tract symptom score (CLSS) and the OAB symptom score (OABSS). 2.Currently receiving or have received treatments for urinary disorders within the past 2 months 3.Subjects who are unable to have the desire to urinate. 4.Subjects who have dysuria as the main symptom 5.Subjects allergic to herbal products or any component of the study product 6.History of uncontrolled chronic or lifestyle related disease 7. Known HIV or Hepatitis B positive or any other immuno-compromised state 8. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement in the Lower urinary tract symptomsTimepoint: Day 1, Day 28, Day 42, Day 56, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| SafetyTimepoint: Day 1, Day 28, Day 42, Day 56, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed