NCT06487871

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

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-08-05
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2024-07-05
• Last updated: 2025-06-06

Locations

6 sites across 1 country: India