Efficacy and safety assesment of angelica root extract compound(SH-PRO-09) on prostate health
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0009039
- Lead Sponsor
- Suheung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 100
1) Men between the ages of 40 and 75 with symptoms of enlarged prostate.
2) Those whose IPSS (International prostate symptom score) is 8 to 19 (Moderate).
3) A person who agrees to participate in this human application test and fills out a written consent form before the human application test begins.
1) Those currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary tract, kidney and urinary, nervous, musculoskeletal, psychiatric, infectious diseases, and malignant tumors.
2) Those with a blood PSA (prostate specific antigen) concentration of 4.0 ng/mL or higher.
3) Those whose maximum urination rate is less than 5 mL/sec.
4) Those with residual urine volume exceeding 150mL.
5) Patients with bladder tumor, urinary stones, urethral stricture, bladder neck contracture, lower urinary tract inflammation, urinary tract tuberculosis, prostatitis, urinary tract infection, acute urinary retention, and neurogenic bladder disease.
6) Those diagnosed with prostate cancer or bladder cancer
7) Those who have undergone surgery related to the genitourinary system, including prostate surgery, or other invasive procedures for prostate treatment.
8) Those with thyroid disease.
9) Those who have taken treatments for prostatic hyperplasia (5-alpha reductase inhibitors, alpha blockers, anticholinergics, antidiuretic hormones, antimuscarinics, etc.) and health functional foods related to prostate health within 4 weeks of visit 1.
10) Those whose creatinine level is more than twice the normal upper limit of the implementing institution.
11) Those whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of normal at the implementing institution.
12) Patients with uncontrolled high blood pressure
13) Patients with uncontrolled diabetes
14) Those who are sensitive or allergic to the food ingredients for this human application test.
15) A person who is deemed unsuitable for this human application test by the tester.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy and safety in improving prostate function when SH PRO 09 (complex of Angelica chive extract) is ingested and when a control food (Placebo) is ingested
- Secondary Outcome Measures
Name Time Method Those who took SH PRO 09 (Angelica root extract complex).;Those who took the control food (Placebo)