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The Effect of Lycopene and FruHis supplementation on serum levels of PSA in BPH patients

The Effect of Lycopene and FruHis supplementation on serum levels of prostate specific antigen (PSA) and clinical outcomes in Benign Prostate Hyperplasia (BPH) patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190522043669N1
Enrollment
80
Registered
2021-03-19
Start date
2020-01-21
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia. Benign neoplasm of prostate

Interventions

Intervention 1: Intervention group: Lycopene and FruHis supplement group (1 capsule daily containing 25 mg lycopene and 10 mg FruHis). Intervention 2: Intervention group: Supplementation group of FruH

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with BPH, whose disease is diagnosed by an urologist, range in age from 50 to 75 years. a serum PSA level between 4-10 ng / ml and have a negative DRE test. Negative DRE test.

Exclusion criteria

Exclusion criteria: Use of Finasteride or other anti-androgen drugs for the last 6 months. Prostate cancer and other malignancies such as skin, myeloma and bladder cancers. Chronic diseases such as severe liver disease and renal failure. Bladder and kidney stones. Lycopene supplementation in the last 6 months Any allergies and sensitivities to tomatoes or tomato products

Design outcomes

Primary

MeasureTime frame
Serum PSA Levels. Timepoint: at the baseline and end of intervention. Method of measurement: Immuno Chemi Luminance.;Serum free-PSA Levels. Timepoint: at the baseline and end of intervention. Method of measurement: Immuno Chemi Luminance.;Serum IGF-1 Levels. Timepoint: at the baseline and end of intervention. Method of measurement: ELISA.

Secondary

MeasureTime frame
Severity of illness. Timepoint: at the baseline and end of intervention. Method of measurement: International Prostate Symptom Score(IPSS) questionnaire.;Quality of life. Timepoint: at the baseline and end of intervention. Method of measurement: International Prostate Symptom Score(IPSS) questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Sadeghi

Tehran University of Medical Sciences

sadeghi-a@razi.tums.ac.ir+98 21 8895 5742

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 11, 2026