A Clinical study to assess the Effectiveness of VISPO on Urinary Symptoms in Female Subjects.

Not yet recruiting

Conditions: Urinary tract infection, site notspecified,

Registration Number: CTRI/2022/10/046779

Lead Sponsor: Vidya Herbs Pvt Ltd

Brief Summary: This is a double-blind, randomized, placebo controlled, parallel group, two arm investigator-initiated study. Female subjects older than 50 years suffering with urinary symptoms and meeting all inclusion and no exclusion criteria after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects were randomized into 2 treatment arms to receive 500 mg capsule of VISPO or placebo in 1:1 ratio. The subject will arrive at the study site in a fasted state and blood samples will be collected for laboratory assessments. The study will be conducted in 3 visits over a period of 12-weeksand telephonic follow-up at week 4th week and 8th week.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 70

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in the Lower urinary tract symptoms	Day 1, Day 28, Day 42, Day 56, Day 84

Secondary Outcome Measures

Name	Time	Method
Safety	Day 1, Day 28, Day 42, Day 56, Day 84

Trial Locations

Locations (1): BGS Global Institute of Medical Sciences
🇮🇳
Bangalore, KARNATAKA, India
BGS Global Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Harshith CS
Principal investigator
9482164779
drharshithcs.research@gmail.com