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

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.

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.