Efficacy and safety assesment of angelica root extract compound(SH-PRO-09) on prostate health

A 12 week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of SH-PRO-09 on Prostate Gland

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009039

Enrollment

100

Registered

2023-12-13

Start date

2021-12-28

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : This clinical trial was designed to evaluate the efficacy and safety of SH-PRO09 (Angelica Extract Complex) in improving prostate function in men with prostate symptoms compared t

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

Measure	Time frame
Those who took SH PRO 09 (Angelica root extract complex).;Those who took the control food (Placebo)	—

Primary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJun Hyun Han

Hallym University Medical Center-Dongtan

junuro@naver.com+82-31-8086-2730

Outcome results