Efficacy and Safety of HU033 on prostate gland health; A 12week Clinical Trial

Not Applicable

Active, not recruiting

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0003992
• Lead Sponsor: Huons

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 135

Inclusion Criteria

1) Men over 40 years old and under 75 years of age
2) International Prostate Symptom Score (IPSS) in the range of 8 to 19)
3) Those who agree to participate in the human aptitude test and who have completed a written consent form prior to the commencement of the Clinical trial

Exclusion Criteria

1) A person currently being treated for clinically significant acute or chronic cardiovascular relationships, immune systems, respiratory systems, gingko systems, kidney and urinary machinery, nervous systems, musculoskeletal disorders, psychotropic, infectious and blood and tumor diseases (however, it is possible to participate in the test according to the judgment of the test taker.)
2) Those with a blood prostate specific antigen (PSA) concentration greater than 4.0ng/ml (but those who have confirmed non-cancer test results within three months prior to this human testing can register)
3) Those with a maximum urination rate of less than 5 ml/s
4) Those who have a residual amount of more than 150 ml
5) bladder tumor, urinary stones, urethral stenosis, bladder construction, lower urinary tract (breathing, urethra) inflammation, urinary tuberculosis disease
6) A person diagnosed with prostate cancer
7) Persons who have undergone an invasive procedure for urinary tract-related surgery, including prostate surgery, and other prostate treatments
8) Patients with unregulated hypertension (160/100mmHg or higher, measured after 10 minutes of stabilization of the test subjects)
9) Unregulated diabetic patients (in case of new drug initiation due to diabetes within 3 months or greater than 180 mg/dl per empty blood)
10) a person with thyroid disease
11) Those whose creatine is more than twice the normal upper limit of the test institution
12) A person whose AST (GOT) or ALT (GPT) is more than three times the normal upper limit of the testing agency.
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14) Persons who participated in another clinical trial within three months prior to this human testing or who plan to participate in another clinical trial during this human testing period
15) Persons who are sensitive or allergic to food related to Quisqualis indica
16) who the Investigation finds inappropriate for this human testing.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IPSS Score

Secondary Outcome Measures

Name	Time	Method
Prostate Specific Antigen, Testosterone, Dihydrotestosterone;Peak flow rate;Residual urine;International Index of Erectile Function;Adverse events;clinical laboratory test(hematologic/chemistry examination, Urinalysis);Vital Sign(pulsus, arteriotony) , Weight