An interventional study of Fucoidan extracted from Undaria pinnatifida (UPF) and Placebo in Benign Prostatic Hyperplasia, sponsored by Vedic Lifesciences Pvt. Ltd.. Completed at 6 sites in India. Open to male participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Other
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 95 is close to the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
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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.
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:
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)
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.
Two capsules to be taken after breakfast daily, with 200 ml glass of water for 90 days.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 90
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0, Day 30, Day 60, Day 90
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Vedic Lifesciences Pvt. Ltd.