Clinical trial NCT06487871: A Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 95
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled trial
Primary purpose: OTHER

Brief 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.

Primary outcomes:
measure: To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
timeFrame: Day 0
measure: To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
timeFrame: Day 30
measure: To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
timeFrame: Day 60
measure: To assess the effect of Investigational product (IP) on prostate health as assessed by the International Prostate Symptom Score (IPSS) as compared to placebo.
timeFrame: Day 90
Secondary outcomes:
measure: To assess the effect of IP on urinary flow rate as assessed by uroflowmetry.
timeFrame: Day 0, Day 90
measure: To assess the effect of IP on Post void residual volume (PVR) as assessed by ultrasonography
timeFrame: Day 0, Day 90
measure: To assess the effect of IP on Prostate-specific antigen (PSA) in serum
timeFrame: Day 0, Day 90
measure: To assess the effect of IP on Perceived immune status as assessed by Immune Status Questionnaire (ISQ)
timeFrame: Day 0, Day 30, Day 60, Day 90
Other outcomes:
Locations:
city: Vadodara
country: India
facility: Sarjanam Hospital
state: Gujarat
city: Nagpur
country: India
facility: NKP Salve Institute of Medical Science and Research Centre and Lata Mangeshkar Hospital
state: Maharashtra
city: Pune
country: India
facility: Rising Medicare Hospital Name of
state: Maharashtra
city: Pune
country: India
facility: Pawana Hospital
state: Maharashtra
city: Pune
country: India
facility: Bhalerao Clinics
state: Maharashtra
city: Jaipur
country: India
facility: Jaipur National University of Medical Science and Research Centre Name of
state: Rajasthan
Study officials:
References: