A Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia
NCT Number: NCT06487871
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Benign Prostatic Hyperplasia
Interventions: DIETARY_SUPPLEMENT: Fucoidan extracted from Undaria pinnatifida (UPF)|DIETARY_SUPPLEMENT: Placebo
Sponsor: Vedic Lifesciences Pvt. Ltd.
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08-04
Completion Date: 2025-02-01
Locations: Parul Sevashram Hospital, Vadodara, Gujarat, 391760, India|NKP Salve Institute of Medical Science and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, 440025, India|Rising Medicare Hospital Name of, Pune, Maharashtra, 141014, India|Bhalerao Clinics, Pune, Maharashtra, 411045, India|Jaipur National University of Medical Science and Research Centre Name of, Jaipur, Rajasthan, 7060924809, India

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.

Primary Outcome Measures: 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 Outcome Measures: To assess the effect of IP on urinary flow rate as assessed by uroflowmetry., Uroflowmetry is a simple procedure to assess urine flow rate over time. The machine provides results including maximum flow rate (Qmax), flow time, voided volume, and average flow rate. Typically, urine flow ranges from 10 ml to 21 ml per second. A low flow rate may indicate potential issues such as bladder neck or urethral obstruction or an enlarged prostate. Conversely, a high flow rate might suggest weak muscles surrounding the urethra or urinary incontinence problems., Day 0, Day 90|To assess the effect of IP on Post void residual volume (PVR) as assessed by ultrasonography, Post void residual volume (PVR) serves as a diagnostic indicator, representing the urine left in the bladder after voluntary voiding. The PVR measurement, typically obtained through a formal bladder ultrasound examination, precisely quantifies the remaining urine shortly after voiding.

PVR volume of less than 50 mL is deemed sufficient for bladder emptying, while in the elderly, a range between 50 and 100 mL is considered normal. Typically, a PVR volume exceeding 200 mL is regarded as abnormal and may indicate incomplete bladder emptying or bladder outlet obstruction. A PVR volume surpassing 400 mL is considered high., Day 0, Day 90|To assess the effect of IP on Prostate-specific antigen (PSA) in serum, PSA, a kallikrein-like serine protease, is primarily produced by prostate epithelial cells to facilitate the liquefaction of ejaculate and support sperm motility. The standard PSA test measures total PSA, encompassing both bound (attached to proteins) and free (unbound) PSA. When both total PSA and free PSA levels are elevated, with a high percentage of free PSA, it typically indicates BPH rather than cancer., Day 0, Day 90|To assess the effect of IP on Perceived immune status as assessed by Immune Status Questionnaire (ISQ), The ISQ is rated on a 5-point Likert scale from 0 to 4.The total sum of ISQ score ranges from 0 to 28, with higher scores indicating poorer immune status., Day 0, Day 30, Day 60, Day 90