benign prostatic hyperplasia
Conditions
Interventions
Test Group:Aland Lycopene plant sterol ester soft capsules
Control group:Placebo
Sponsors
The 983rd Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Eligibility
Sex/Gender
Male
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Men aged 35-65 years old; (2) IPSS score greater than 0 and less than or equal to 19; (3) Prostate hyperplasia of grade 2 or below (prostate ultrasound examination); (4) Those who voluntarily participate in the experiment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals who are unable to eat orally or take the test substance as prescribed; (2) Individuals who are intolerant or allergic to the test substance; (3) Those with unclear chief complaints; (4) Serum prostate antigen PSA>10.0 µ g/L; (5) Patients with serious diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as psychiatric disorders; (6) History of taking anti androgen drugs within six months (such as finasteride, bicalutamide tablets, ketoconazole, Flutamide, Nilutamide, Apatamide, Enzalutamide, Daloramide, spironolactone, spironolactone, finasteride, etc.); (7) History of taking health supplements or 5 a - reductase inhibitors, a 1 adrenergic receptor antagonists, and anticholinergic drugs that interfere with the test within 3 months (health supplements: health supplements containing lycopene/sawdust/epigallocatechin gallocatechin gallate or Qianliekang; anticholinergic drugs: dutasteride, irinotecan, simulated nitrogen, simulated aprepitide, benzoic acid inhibitors, atropine, etc.; 5 a - reductase inhibitors: scopolamine, scopolamine, belladonna, antispasmodin (scopolamine bromide), propofol, aprepitide tablets, etc.); a 1-adrenergic receptor antagonists: phentolamine (levocetirizine) and tolazoline (benzylazoline), etc; (8) Previous urological history (including urethral stricture disease/bladder neck disease/recurrent urinary tract infection/urinary retention/bladder or urethral calculus/acute or chronic prostatitis/prostate/bladder cancer cancer/interstitial cystitis/active upper segment calculus), or surgical history or other chronic diseases that are not suitable for the test; (9) Participants in other clinical trials in the past 3 months. (10) Those who have not taken the test substance as prescribed, and whose incomplete data affects the efficacy or safety assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Flow Rate;Prostate volume;Dihydrotestosterone;Prostate symptoms;Comprehensive Prostate Symptom Status;Quality of life situation;Nighttime frequency; | — |
Countries
China
Contacts
Public ContactMeng Yongxia
The 983rd Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Outcome results
None listed