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

Main Objective: To determine the effect of Lycopene and Fruhis supplementation on plasma PSA levels and clinical parameters in patients with BPH. Sub-objectives of the project: Determining the effect of lycopene and FruHis supplementation on prostate size in patients with BPH Determining the effect of lycopene and Fruhis supplementation on serum PSA and Free PSA levels in patients with BPH Determining the effect of lycopene and FruHis supplementation on the factors affecting prostate cell proliferation (IGF-1) in patients with BPH Practical goals of the project: If the hypotheses of this study are met, we can help increase the effectiveness of common supplements for patients with BPH by conducting additional studies and further studies, by adding FruHis to lycopene supplements.

double blind randomized clinical trial with a parallel group design

Sampling will be done at Imam Khomeini Hospital in Tehran. Sampling will be done using available method and based on inclusion criteria. People who will be involved in sampling and statistical analysis will not be aware of the code of individuals and their placement in the study groups, and randomization will be done by someone else (in charge of the College Lab) who is not participating in the study.

Patients with BPH, aged between 50-75, were diagnosed by Urologist that have negative DRE test. People with prostate cancer or other malignancies who have been taking finasteride or other anti-androgen drugs for the past 6 months and also allergic to tomatoes will not be included in the study.

1) Lycopene and FruHis supplementation group 2) Lycopene supplementation group 3) FruHis supplementation group and 4) Control group

PSA, IGF-1,Severity of disease and quality of life of patients

Before intervention, subjects were first stratified by age (55-60 years and 60-75 years), BMI (25≥ BMI and 25≤ BMI) and opium consumption (with or without) by stratified randomization method and There will be in the binary blocks. Subjects were randomly assigned to four groups: 1- Lycopene and FruHis supplementation group (1 capsule daily containing 25 mg lycopene and one capsule containing 10 mg FruHis) 2- Lycopene supplementation group (2 capsules daily containing 25 mg lycopene) 3- FruHis Supplementation group (2 capsules daily containing 10 mg FruHis) 4- Control group (2 capsules similar other groups). For the purpose of random allocation, the code of individuals who are matched for the three variables mentioned is first poured into pots and the matched individuals are randomly divided into intervention groups.

Researchers involved in sampling and statistical analysis will not be aware of the code of individuals and their placement in the study groups, and randomization will be done by someone else (university lab officer) not involved in the study. The medical team, the data monitoring safety committee, will also be aware of the blinding process. Blinding: The patient takes the supplements (intervention groups or placebo groups) in enclosed packages. Coded by one of the partners' designs It takes place and blinds the doctor, the administrator and the patient.

The study protocol will be written and published in the form of an article. Clinical report of our study will be published after finishing data gathering

3 months after end of study

The study findings will be made available to the general public

For use in clinic or written a review article. For original studies, it will be permitted if they acknowledge our study personnel

Using Email, by author who are responsible for updating data

After receiving application by the author who are responsible for updating data and following consultation with scientific consultant, data will be provided