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CTRI Number  CTRI/2023/11/060343 [Registered on: 29/11/2023] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Exploring the Efficacy of P Grace: A Promising Intervention for Managing Benign Prostatic Hyperplasia (BPH) - An Open-Label, Single-Centric Clinical Study 
Scientific Title of Study   An open-label, single-centric, Interventional clinical study to assess the effectiveness of P Grace in the Management of Benign Prostatic Hyperplasia (BPH).  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
PHAR/CT/2023/09  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Mahesh 
Designation  Consultant 
Affiliation  Gita Clinic 
Address  Gita Clinic No 238 4th Cross 4th main Nelamaheshwaramma road Near Byalappa Circle Dasarahalli

Bangalore
KARNATAKA
560057
India 
Phone  8105868530  
Fax    
Email  drpriyankamahesh1990@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Baburao Vikram 
Designation  Director 
Affiliation  Pharexcelconsulting private Limited 
Address  Clinical Research Dept, Ground floor, room number 1, plot 11, 10th cross AYR layout, Shettihalli Bengaluru Karnataka 560015 India

Bangalore
KARNATAKA
560015
India 
Phone  09878551428  
Fax    
Email  info@pharexcelconsulting.com  
 
Details of Contact Person
Public Query  
Name  Mr Sunil Gupta 
Designation  Managing Director 
Affiliation  Nutra Grace 
Address  NUTRA GRACED B11 7 11 8 IDA Uppal Hyderabad 500039 Telangana India

Bangalore
KARNATAKA
500039
India 
Phone  9000007983  
Fax    
Email  sunil@nutragrace.com  
 
Source of Monetary or Material Support  
Nutra Grace B 11/7 11/8 IDA Uppal Hyderabad 560039 Telangana INDIA 
 
Primary Sponsor  
Name  Nutra Grace 
Address  NUTRA GRACE B 11 7 11 8 IDA Uppal Hyderabad 500039 Telangana India 
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 Priyanka Mahesh  Gita Clinic  Gita Clinic No 238 4th 4th cross 4th main Nelamaheshwaramma Road Bylappa Circle
Bangalore
KARNATAKA 		 8105868530

drpriyankamahesh1990@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pharexcel Independent Ethics Committee Pharexcel Consulting Private Limited Plot No. 11, 10th Cross, AYR Layout, Shettihalli, Jalhalli, West Banglore Karnataka Bengaluru (Bangalore) Urban Karnataka - 560015 India  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  NA  NA 
Intervention  P grace (Pumpkin seed oil 320 mg) capsules  1 capsule twice daily along with food morning and evening for 3 months. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  Aged 45 years and above male subjects.
Subjects must have low to moderate BPH symptoms.
Subjects having symptoms such as delay in initiating micturition,
hesitancy, weak urinary stream, straining to void, sensation of
incomplete emptying and terminal dribbling.
Subjects with increased residual urine volume.
USG prostate volume not more than 80 cc.
Nocturia, Urgency, bladder pain, dysuria.
Willingness to sign the informed consent, follow the protocol, and
participate in clinical trials voluntarily. 
 
ExclusionCriteria 
Details  Patients with malignancy, Congenital deformities of urogenital tract or
any pathology other than BPH.
Patients with high Diabetes Mellitus Hypertension
systolic 140 mm Hg or higher diastolic 90 mm Hg or higher, Renal
disorders or any other systemic disease.
Patients planned for surgical treatment of BPH.
Urinary bladder calculus.
History of chronic prostatic diseases.
Patients with disturbed low BPH associated QoL scores.
Allergy or sensitivity to pumpkin seed oil. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To improve IPSS in patients of BPH  Visit 1 Screening Visit Day 0
Visit 2 Month 1 Week 4
Visit 3 Month 2 Week 8
Visit 4 Month 3 Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
To asses the change in the PSA level  Baseline and Month 3 (Week 12) 
To asses the change in the QOL  Baseline and Month 3 (WEEK 12) 
To assess the adverse events and vital signs  Baseline, Month 1 (Week 4), Month 2 (Week 8) and Month 3 (Week 12) 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   05/12/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  NA

  2. What additional supporting information will be shared?
    Response (Others) -  NA
  3. Who will be able to view these files?
    Response (Others) -  NA

  4. For what types of analyses will this data be available?
    Response (Others) -  NA

  5. By what mechanism will data be made available?
    Response (Others) -  NA

  6. For how long will this data be available start date provided 16-04-2024 and end date provided 31-03-2025?
    Response (Others) -  NA

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary  

Benign Prostatic Hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland, causing bothersome urinary symptoms in men like delay in initiating micturition, hesitancy, and dribbling. For the management of BPH, medical therapy options are available with α-blockers or 5-α-reductase inhibitors, and surgery.

To reduce the risks of associated side effects with these treatment options, alternative medicines (AM) are put into use by many individuals regularly. One of these commonly used AM involves Pumpkin Seed Oil (PSO). PSO contains phytosterols, antioxidants, and essential fatty acids like Omega-3 and Omega-6, explaining its anti-inflammatory and antioxidant properties. Several preclinical and clinical studies explain PSO in potentially reducing biomarkers of BPH like PSA and alleviating the associated symptoms.   

P Grace Capsules- PSO(320 mg) is administered to a total 120 subjects- One capsule twice a day along with food, in the morning and evening, consistently over 12 weeks.

Primary Study Objective: Assessment of International Prostate Symptom Score (IPSS).

Secondary Objectives:

(1) Assessing Quality of Life (QoL),

(2) changes in serum prostate specific antigen (PSA) levels,

(3) changes in maximum urine flow (Uroflowmetry), and

(4) reduction in the size of the prostate gland and prostate volume and residual urine volume using an Ultrasound scan.

 

 
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