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

Phase 3

• Conditions: Benign Prostate Hyperplasia.; Benign neoplasm of prostate; D29.1

• Registration Number: IRCT20190522043669N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 80

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.