CTRI

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CTRI Number

CTRI/2024/06/068991 [Registered on: 18/06/2024] Trial Registered Prospectively

Last Modified On:

06/04/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Nutraceutical

Study Design

Single Arm Study

Public Title of Study

To see the Efficacy and Safety of ProPlus Capsules in patients with Benign Prostatic Hyperplasia (BPH)

Scientific Title of Study

A Prospective Interventional Open label Single centre Single arm Study to Evaluate the Efficacy and Safety of ProPlus Capsules in Subject suffering with Benign Prostatic Hyperplasia (BPH)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
007/ACRS/ProPlus/2024 Version 1.0 dated 5th Apr 2024	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Upendra Kudlikar
Designation	General Surgeon
Affiliation	Saikrupa Hospital
Address	Urology department 2nd floor Sai krupa hospital and research centre 41141 B sector 34 renuka corner tapkir chowk Pune MAHARASHTRA 411033 India
Phone	7030729676
Fax	-
Email	drup.research@gmail.com

Details of Contact Person
Scientific Query

Name	Mr Chandu Devanpally
Designation	Founder & Managing Director
Affiliation	Ardent Clinical Research Services
Address	Office no 302 303 Level 3 Nyati Unitree Building yerwada Pune Pune MAHARASHTRA 411006 India
Phone	9545817447
Fax	-
Email	swati.k@ardent-cro.com

Details of Contact Person
Public Query

Name	Mr Chandu Devanpally
Designation	Founder & Managing Director
Affiliation	Ardent Clinical Research Services
Address	Office no 302 303 Level 3 Nyati Unitree Building yerwada Pune Pune MAHARASHTRA 411006 India
Phone	9545817447
Fax	-
Email	swati.k@ardent-cro.com

Source of Monetary or Material Support

Ardent Clinical Research Services office no 302 303 level 3 Nyati unitree building pune nagar highway yerwada 411006 Pune INDIA

Primary Sponsor

Name	M/s Synthite Industries Private Limited
Address	Synthite Corporate House VIII 683 A Kadayiruppu Kolenchery Ernakulam Kerala 682 311
Type of Sponsor	Pharmaceutical industry-Indian

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 Upendra Kudilkar	Sai Krupa Hospital & research Centre	Urology Department 2nd floor Sai Krupa Hospital and Research Center 41141 B sector 34 Renuka Corner Tapkir Chowk Pune 411033 INDIA Pune MAHARASHTRA	7030729676 - drup.research@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Sai Krupa Hospital Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N401\|\|Benign prostatic hyperplasia withlower urinary tract symptoms,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Not Applicable	Not Applicable
Intervention	Proplus(Pumpkin seed oil Quercetin Vitamin D3 and Selenium) Nutraceutical product	01 capsule once in a day after lunch with defined standard of care for 90 Days duration

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Male
Details	1 Male Patients of age between 18 years to 65 years both inclusive who are diagnosed case of benign Prostatic Hyperplasia 2 Patients having International Prostate Symptom Score IPSS greater than or equal to 8 moderate to severe BPH at time of enrollment 3 Patients having Qmax between 5 ml per sec and 15ml per sec both included with minimum voided volume of greater than 125 ml at the time of Screening 4 Patients having post voiding residue PVR of less than 300 ml as assessed by Ultrasound at screening 5 Patient is willing to give Informed Consent

ExclusionCriteria

Details

1 Prostate specific antigen (PSA) beyond 4 ng per mL at screening and enrolment
2 Patient with history of neurologic bladder urethral strictures urinary tract infections prostatitis urologic cancer and prostatic surgery
3 Patient with clinically significant bladder outflow obstruction other than BPH (calculi tumour or stricture) as judged by Investigator
4 Clinical evidence of any other bladder or urinary tract conditions which may affect lower urinary tract symptoms at screening
5 Patient undergoing hemodialysis
6 Patient who are planning for cataract or glaucoma surgery
7 Patients with history of cardiovascular disease
including but not limited to
History of Myocardial Infraction within the last 90 days
History of angina
History of congestive cardiac failure
History with uncontrolled arrhythmias hypotension Blood Pressure less than 90 per 60 mm Hg uncontrolled hypertension greater than or equal to 170 per 100 mm Hg

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1 Improvement in Total International Prostate Symptom Score (IPSS) 2 Definition of improvement Reduction in IPSS score of â‰¥25%	from baseline to End of treatment

Secondary Outcome

Outcome

TimePoints

1 Improvement in maximum urinary flow rate (Qmax) & Change in Qmax
2 Evaluation of change in Total IPSS storage(Irritative) score
3 Evaluation of change in Total IPSS voiding (Obstructive)score
4 Evaluation of change in Total IIEF-EF score
5 Reduction in inflammation of prostate area
6 Improvement in Prostate specific antigen (PSA) level
7 Improvement in PVR volume from screening
8 Evaluation of change in Quality of Life (QOL) Index score
9 Reduction in frequent urination

1 Baseline(Day 0) & EOT (Day 90)
2 baseline to EOT(Day 90)
3 baseline to EOT(Day 90)
4 baseline to EOT(day 90)
5 baseline to EOT (Day 90)
6 baseline to EOT(Day 90)
7 baseline to EOT(day 90)
8 baseline to EOT(Day90)
9 baseline to EOT (Day 90)

Target Sample Size

Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0"

Phase of Trial

N/A

Date of First Enrollment (India)

26/06/2024

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

The study is designed as Prospective, Interventional, Open label, Single-centre, Single arm. Participants enrolled in this prospective, interventional, open-label, single-center, single-arm study will receive the ProPlus Capsule along with defined SoC, a formulation comprising Pumpkin seed oil, Quercetin, Vitamin D3 and Selenium. The treatment regimen is designed to assess the safety and efficacy of this capsule in individuals experiencing Benign Prostate hyperplasia (BPH). The treatment duration will be 3 months, with each participant taking 1 capsule a day (after lunch). Various parameters will be assessed including Quality of Life questionnaires, Hematology, Biochemistry, PSA level, Urine flow and Liver function. Adverse Events (AE) and Serious Adverse Events (SAE) will be monitored and documented throughout the study duration.