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CTRI Number  CTRI/2022/10/046779 [Registered on: 26/10/2022] Trial Registered Prospectively
Last Modified On: 21/10/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical study to assess the Effectiveness of VISPO on Urinary Symptoms in Female Subjects. 
Scientific Title of Study   A Double-Blind, Randomized, Placebo Controlled, Parallel Group,Clinical Trial Assessing the Effectiveness and Safety of VISPO on Urinary Symptoms in Female Subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshith C S 
Designation  Assistant Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9482164779   
Fax    
Email  drharshithcs.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd. 
Address  Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan Nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd. 
Address  Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan Nagar


KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Vidya Herbs Pvt Ltd ,Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078 
 
Primary Sponsor  
Name  Vidya Herbs Pvt Ltd  
Address  Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India 
Type of Sponsor  Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshith CS  BGS Global Institute of Medical Sciences  Department of General Medicine No.67, BGS Health and Education City,Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 9482164779

drharshithcs.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N390||Urinary tract infection, site notspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  500 mg maltodextrin capsule  Oral administration of single dose of Placebo 500mg capsule every night for 84 days 
Intervention  VISPO, 500 mg capsule  Oral administration of single dose of VispoTM 500mg capsule every night for 84 days 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
improvement in the Lower urinary tract symptoms  Day 1, Day 28, Day 42, Day 56, Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Safety  Day 1, Day 28, Day 42, Day 56, Day 84 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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