A Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia

NCT06487871 | Completed

• 1 other identifier: MN/231202/IP/BPH
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 6

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (4)

• To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.

  The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH). Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms. Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.

  Day 0

• To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.

  The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH). Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms. Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.

  Day 30

• To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.

  The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH). Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms. Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.

  Day 60

• To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.

  The International Prostate Symptom Score (IPSS) consists of seven questions that assess both storage and voiding symptoms in participants with Benign Prostatic Hyperplasia (BPH). Respondents are presented with six response options for each of the seven questions, with scores ranging from 0 to 5 indicating the severity of the respective symptom. The total sum score, ranging from 0 to 35, aids in categorizing the severity of lower urinary tract symptoms (LUTSs): 0 - 7 indicates mild symptoms, 8 - 19 indicates moderate symptoms, and 20 - 35 indicates severe symptoms. Additionally, the final question of the IPSS addresses Quality of Life (QoL), with responses varying from "delighted" to "terrible" or scores from 0 to 6.

  Day 90

Secondary Outcomes (4)

• 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

Study Arms (2)

Fucoidan extracted from Undaria pinnatifida (UPF)

ACTIVE COMPARATOR

Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days.

Dietary Supplement: Fucoidan extracted from Undaria pinnatifida (UPF)

Placebo

PLACEBO COMPARATOR

Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days.

Dietary Supplement: Placebo

Interventions

Fucoidan extracted from Undaria pinnatifida (UPF) DIETARY_SUPPLEMENT

Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days.

Fucoidan extracted from Undaria pinnatifida (UPF)

Placebo DIETARY_SUPPLEMENT

Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days.

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: Only biological males will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Moderate symptoms with an IPSS Score more than or equal to 8-19.
• No signs of prostate cancer as indicated by 1-3 U/L of Prostatic Acid Phosphatase (PAP) in serum.
• Fasting blood glucose (FBG) less than 125 mg/dL.
• 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.

You may not qualify if:

• Males with no signs of inflammation as assessed by Erythrocyte Sedimentation Rate (ESR) of more than or equal to 20 mm/hr.
• Males with more than or equal to 3.5 ng/mL of PSA in serum.
• Males diagnosed with prostate cancer.
• Males who have recently started a bladder-training program within the last 30 days.
• Males who have undergone urogenital surgery.
• Males who have had a bladder biopsy and/or cystoscopy and biopsy within the last 30 days.
• Males who have had an indwelling catheter or practiced self-catheterization, and/or urethral stricture within the last 30 days.
• Males diagnosed with obstructive renal/urinary tract calculi.
• Males who have been medically diagnosed with chronic persistent local pathology (i.e., interstitial cystitis, prostatitis, etc.)
• Males with chronic inflammatory diseases such as Rheumatoid arthritis (RA), Ulcerative colitis, and Chronic obstructive pulmonary disease (COPD).
• Males receiving or prescribed anticoagulation therapy.
• Males who have been diagnosed with severe renal and/or hepatic insufficiency.
• Males who have been diagnosed with genital anatomical deformities.
• Males with a history of uncontrolled diabetes mellitus, uncontrolled hypertension (SBP/DBP ≥ 140/90 mmHg1 with or without medication), thyroid disorders, spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics.
• Males who have a history of chronic alcohol (defined as consuming more than 5 drinks on any day or more than 15 drinks/week2) and/or illicit drug abuse.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (6)

Sarjanam Hospital

Vadodara, Gujarat, 390012, India

Location

NKP Salve Institute of Medical Science and Research Centre and Lata Mangeshkar Hospital

Nagpur, Maharashtra, 440025, India

Location

Rising Medicare Hospital Name of

Pune, Maharashtra, 141014, India

Location

Pawana Hospital

Pune, Maharashtra, 410506, India

Location

Bhalerao Clinics

Pune, Maharashtra, 411045, India

Location

Jaipur National University of Medical Science and Research Centre Name of

Jaipur, Rajasthan, 7060924809, India

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: August 5, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

IN (6)