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

NCT ID: NCT06487871

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2025-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Fucoidan extracted from Undaria pinnatifida (UPF)

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

Group Type: ACTIVE_COMPARATOR

Fucoidan extracted from Undaria pinnatifida (UPF)

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Fucoidan extracted from Undaria pinnatifida (UPF)

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Males who have participated in any other clinical study during the last 30 days.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sarjanam Hospital

Vadodara, Gujarat, India

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

Nagpur, Maharashtra, India

Rising Medicare Hospital Name of

Pune, Maharashtra, India

Pawana Hospital

Pune, Maharashtra, India

Bhalerao Clinics

Pune, Maharashtra, India

Jaipur National University of Medical Science and Research Centre Name of

Jaipur, Rajasthan, India

Countries

India

Other Identifiers

MN/231202/IP/BPH

Identifier Type: -

Identifier Source: org_study_id