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CTRI Number  CTRI/2022/02/039901 [Registered on: 01/02/2022] Trial Registered Prospectively
Last Modified On: 30/01/2022
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 asses the efficacy and safety of JACKPROTM 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel-group, single center clinical study to evaluate the efficacy and safety of JACKPROTM in comparison to placebo in the treatment of benign prostate hyperplasia and androgen deficiency. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M E Mohan 
Designation  Principal Investigator  
Affiliation  BGS Global Institute of Medical Sciences  
Address  Department of General Medicine BGS Global Institute of Medical Sciences #67, BGS health and Education city, Uttarahalli road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9482164779  
Fax    
Email  drmohanbgsresearch@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

Bangalore
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,India  
 
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 M E Mohan   BGS Global Institute of Medical sciences   Department of General Medicine, BGS Global Institute of Medical Sciences #67, BGS health and Education city, Uttarahalli road, Kengeri
Bangalore
KARNATAKA 		 9482164779

drmohanbgsresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BGS Global Institute of Medical Scineces Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N40||Benign prostatic hyperplasia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  JACKPROTM  Oral administration of single dose of JACKPROTM capsules everyday for 84 days  
Comparator Agent  Placebo  Oral administration of single dose of Placebo capsules everyday for 84 days  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  1.At screening, subject has IPSS score greater than 7,AMS score greater than 27 and ADAM questionnaire items 1 or 7 or any 3 other questions as positive
2.Must be willing and able to give informed consent and comply with the study procedures


 
 
ExclusionCriteria 
Details  1.Has a history of prostate cancer or carcinoma of the prostate or Subjects with known history of serum PSA concentration greater than 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator.
2.Has a residual void volume greater than 250 mL
3.History of Neurogenic bladder dysfunction or bladder neck contracture or urethral stricture r acute or chronic prostatitis or urinary tract infection or Serious medical co-morbidity including Haematuria diabetes,any prior surgery which could induce dysuria, Use of any other herbal medications for treatment of BPH,or associated symptoms and Erectile Dysfunction in past 1 month or Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months
4.Subjects allergic to herbal products or any component of the study product
5.Known HIV or Hepatitis B positive or any other immuno-compromised state
6.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
7.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 
Mean Change in Post-voidal residual volume of urine and change in Questionnaire based assessments  Day 0, Day 42, Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in uroflowmetry parameters  Day 0, Day 84 
Mean change in the male hormonal markers   Day 0, Day 84 
Mean change in Quality of Life Questionnaire  Day 0, Day 42, 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)   02/02/2022 
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   "None Yet" 
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 (1:1), placebo controlled, parallel group, two arm, single center study. Elderly male subjects 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 will be randomized into 2 treatment arms to receive JACKPROTM  or placebo  in 1:1 ratio.The subject will arrive at the study site in a fasting state and blood samples will be collected for laboratory assessment  and questionnaire based assessments will be performed.The study is planned to be conducted in 3 visits over a period of 12 weeks.

 
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