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

NCT06487871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2025-06-06

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Fucoidan extracted from Undaria pinnatifida (UPF)

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Vedic Lifesciences Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2025-01-15
Completion
2025-01-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06487871 on ClinicalTrials.gov