Status:
COMPLETED
A Study to Assess the Effect of Fucoidan on Prostate Health in Males With Benign Prostatic Hyperplasia
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45-80 years
Phase:
NA
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 randomi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2025
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT06487871
Start Date
August 5 2024
End Date
January 15 2025
Last Update
June 6 2025
Active Locations (6)
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1
Sarjanam Hospital
Vadodara, Gujarat, India, 390012
2
NKP Salve Institute of Medical Science and Research Centre and Lata Mangeshkar Hospital
Nagpur, Maharashtra, India, 440025
3
Rising Medicare Hospital Name of
Pune, Maharashtra, India, 141014
4
Pawana Hospital
Pune, Maharashtra, India, 410506