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CTRI Number  CTRI/2024/07/071419 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
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 study to assess the effect of fucoidan on prostate health in males with benign prostatic hyperplasia 
Scientific Title of Study   A randomized, double-blind, placebo-controlled study to assess the effect of fucoidan on prostate health in males with benign prostatic hyperplasia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MN 231202 IP BPH, Version No. 1.0, Date: June 17, 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Srivastava 
Designation  Director- Clinical Development and Strategy 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  B-118, Morya House Off. New Link Road, Andheri(West), Mumbai, Maharashtra, India

Mumbai
MAHARASHTRA
400053
India 
Phone  8655448527  
Fax    
Email  shalini.s@vediclifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalini Srivastava 
Designation  Director- Clinical Development and Strategy 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  B-118, Morya House Off. New Link Road, Andheri(West), Mumbai, Maharashtra, India


MAHARASHTRA
400053
India 
Phone  8655448527  
Fax    
Email  shalini.s@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhangi Mote 
Designation  Project Lead- Clinical Development 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  B-118, Morya House Off. New Link Road, Andheri(West), Mumbai, Maharashtra, India

Mumbai
MAHARASHTRA
400053
India 
Phone  8655448527  
Fax    
Email  shubhangi.m@vediclifesciences.com  
 
Source of Monetary or Material Support  
Vedic Lifesciences Pvt. Ltd, B-118, Morya House, Off New Link Road, Andheri West, Mumbai-400053 
 
Primary Sponsor  
Name  Vedic Lifesciences Pvt. Ltd. 
Address  B-118, Morya House, Off New Link Road, Andheri West, Mumbai-400053 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sagar Bhalerao  Bhalerao Clinics  1st floor, Park marina, 1/2, Vardan Bunglow Rd, Above daily delights and kulfi house, Opposite Jupiter Hospital, Baner, Pune, Maharashtra- 411045, India.
Pune
MAHARASHTRA 		 9819846896

bhaleraosagar@gmail.com 
Dr Chirag Gupta  Jaipur National University of Medical Science and Research Centre  Jaipur National University of Medical Science and Research Centre-302017, India.
Jaipur
RAJASTHAN 		 7060924809

drchiragjnu@gmail.com 
Dr Nandkishor Raut  Pawana Hospital  Pawana Hospital, Gate No-167 Urse, Parandwadi Road,Somatne phata, Maval, Pune 410506, Maharashtra, India.
Pune
MAHARASHTRA 		 9404904176

surgeon.nandkishor@gmail.com 
Dr Kalpesh Saswade  Rising Medicare Hospital  Surve No 4/1, Mundhawa-Kharadi Road, behind Radisson’s Blu, Pandhari Nagar, Kharadi Pune 411014, Maharashtra, India.
Pune
MAHARASHTRA 		 766818096

drkalpeshsaswade@gmail.com 
Dr Saurabh Pandya  Sarjanam Superspeciality Hospital  Sarjanam Superspeciality Hospital, 2nd Floor, Marvel Square, Sun Pharma Rd, Vadodara, Gujarat 390012.
Vadodara
GUJARAT 		 9725288822

drsaurabhpandyaicr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Anand Institutional Ethics Committee  Approved 
Institutional Ethics Committee, JNUIMSRC  Approved 
Rising Medical Care Hospital and IEC  Approved 
Royal Pune Independent Ethics Committee  Approved 
Skinovate Independent Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N400||Benign prostatic hyperplasia without lower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fucoidan extracted from Undaria pinnatifida (UPF)  Two capsules to be taken after breakfast daily, with 200 ml of water for 90 days.  
Comparator Agent  Placebo  Two capsules to be taken after breakfast daily, with 200 ml of water for 90 days. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  1. Males aged 45 to 80 years (inclusive of both ages) with a diagnosis of BPH established by a surgeon/nephrologist/urologist within the last 3 months and having any one of the two clinical as well as one of the radio-diagnostic parameters:-
a) Clinical parameter:
i) History of lower urinary tract symptoms
ii) Rectal examination indicating increased prostate size.
b) Radio-diagnostic parameter:
i) Uroflowmetry (less than 20 ml/sec maximum flow rate [Qmax])
ii) Ultrasound Sonography (USG) – Enlargement of the central gland with a calculated urine volume exceeding 30 mL and increased post-micturition.
2. Moderate symptoms with an IPSS Score more than or equal to 8 to 19.
3. No signs of prostate cancer as indicated by 1-3 U/L of Prostatic Acid Phosphatase (PAP) in serum.
4. Fasting blood glucose (FBG) less than 125 mg/dL.
5. Willing to give voluntary written informed consent and adhere to all the requirements of the study.
Note: Only biological males will be included.
During screening I, if participants are currently on drug/ supplement for BPH, a washout period of 10±2 days will be provided. After this period, the participant will be rescheduled for screening IA. 
 
ExclusionCriteria 
Details  1. Males with no signs of inflammation as assessed by Erythrocyte Sedimentation Rate (ESR) of more than or equal to 20 mm/hr.
2. Males with more than or equal to 3.5 ng/mL of PSA in serum.
3. Males diagnosed with prostate cancer.
4. Males who have recently started a bladder-training program within the last 30 days.
5. Males who have undergone urogenital surgery.
6. Males who have had a bladder biopsy and/or cystoscopy and biopsy within the last 30 days.
7. Males who have had an indwelling catheter or practiced self-catheterization, and/or urethral stricture within the last 30 days.
8. Males diagnosed with obstructive renal/urinary tract calculi.
9. Males who have been medically diagnosed with chronic persistent local pathology (i.e., interstitial cystitis, prostatitis, etc.)
10. Males with chronic inflammatory diseases such as Rheumatoid arthritis (RA), Ulcerative colitis, and Chronic obstructive pulmonary disease (COPD).
11. Males receiving or prescribed anticoagulation therapy.
12. Males who have been diagnosed with severe renal and/or hepatic insufficiency.
13. Males who have been diagnosed with genital anatomical deformities.
14. Males with a history of uncontrolled diabetes mellitus, uncontrolled hypertension (SBP/DBP ≥ 140/90 mmHg with or without medication), thyroid disorders, spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics.
15. Males who have a history of chronic alcohol (defined as consuming more than 5 drinks on any day or more than 15 drinks/week) and/or illicit drug abuse.
16. Males who have participated in any other clinical study during the last 30 days. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.  Day 0, Day 30, Day 60, Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of IP on urinary flow rate as assessed by uroflowmetry  Day 0, Day 90 
To assess the effect of IP on Post void residual volume (PVR) as assessed by ultrasonography  Day 0, Day 90 
To assess the effect of IP on Prostate-specific antigen (PSA) in serum  Day 0, Day 90 
To assess the effect of IP on Perceived immune status as assessed by Immune Status Questionnaire (ISQ)  day 0, day 30, day 60, day 90 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="95" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   05/08/2024 
Date of Study Completion (India) 15/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
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 present study is a randomized, double-blind, placebo-controlled study. Approximately 125 individuals will be screened, and considering a screening failure rate of 20%, at least 100 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have not less than 40 completed participants after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 90 days. 
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