Efficacy and safety of HT080 on prostate gland health: a 12-week, randomized, double-blind, placebo-controlled clinical trial.

Recruitment & Eligibility

Status: Not yet recruiting

Sex: Male

Target Recruitment: 100

Inclusion Criteria

1) Men aged 40 to 75 years
2) International Prostate Symptom Score of 8 to 19
3) Prostate size of = 20 g
4) Participants who agree to participate and sign the informed consent

Exclusion Criteria

1) Currently being treated for clinically relevant acute or chronic cerebrovascular, immune, respiratory, hepatobiliary, kidney and urinary, neurological, musculoskeletal, mental, infectious, or hemato-oncological diseases (However, it is possible to participate in the trial at the investigator’s discretion considering the condition of the participants)
2) Serum PSA level = 10 ng/ml (However, those whose test results are had not been confirmed as cancer within 6 months can be enrolled)
3) Maximal urinary flow rate (Qmax) less than 5 mL/sec
4) Post-void residual urine volume (PVR) greater than 200 mL
5) Bladder tumor, urinary stone, urethral stricture, bladder neck contracture, inflammation of the lower urinary tract (bladder and urethra), or urinary tuberculosis
6) Diagnosed as prostate cancer
7) History of genitourinary surgery including prostate surgery or other invasive procedures for prostate treatment (trans-urethral needle ablation, laser treatment, etc.)
8) Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg measured after a 10-min rest)
9) Uncontrolled diabetes (fasting blood sugar level = 180 mg/dL or those who have started to take drugs because of diabetes within 3 months)
10) Thyroid diseases
11) Creatinine level = 2 times the upper limit of normal
12) Aspartate and alanine aminotransferase levels = 3 times the upper limit of normal
13) Received drugs for BPH (antimuscarinics, etc.) or functional foods within 4 weeks
14) Participation in other clinical trials within 3 months or plan to participate in other trials during this study
15) Participants who are deemed unsuitable at the investigator’s discretion

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score

Secondary Outcome Measures

Name	Time	Method
serum prostate specific antigen and testosterone levels;Serum dihydrotestosterone level;Uroflowmetry (Peak flow rate );Residual urine volume;International Index of Erectile Function;Global Response Assessment