a study to assess the effect of fucoidan on prostate health in males with benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

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.


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.