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IRCT20190522043669N1 IRCT 2021-03-19 Tehran University of Medical Sciences 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 2020-01-21 anticipated 80 Complete https://irct.ir/trial/40090 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Benign Prostate Hyperplasia. 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 FruHis (2 capsuleس daily containing 10 mg FruHis). Intervention 3: Intervention group: Lycopene supplementation group (2 capsules daily containing 25 mg lycopene). Intervention 4: Control group: placebo group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Alireza Sadeghi
No. 44, Hojatdost Ave, Naderi Ave, Keshavarz Blvd, Tehran city
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8895 5742 sadeghi-a@razi.tums.ac.ir Tehran University of Medical Sciences scientific Alireza Sadeghi
No. 44, Hojatdost Ave, Naderi Ave, Keshavarz Blvd, Tehran city
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8895 5742 sadeghi-a@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 50 years 75 years Male 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 D29.1 Benign neoplasm of prostate Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: Lycopene and FruHis supplement group (1 capsule daily containing 25 mg lycopene and 10 mg FruHis) Intervention group: Supplementation group of FruHis (2 capsuleس daily containing 10 mg FruHis) Intervention group: Lycopene supplementation group (2 capsules daily containing 25 mg lycopene) Control group: placebo group 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. 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. Tehran University of Medical Sciences Approved 2019-02-12 Ethics committee of Tehran University of Medical Sciences Flat. 6, Office Building of Tehran University of Medical Sciences, Qods Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)