Herbal Supplement Prosta-OK® Neo as an Adjunct Therapy in Patients With Mild to Severe Non-neurogenic Male Lower Urinary Tract Symptoms Receiving Tamsulosin Therapy
Herbal Supplement Prosta-OK® Neo as an Adjunct Therapy in Patients With Mild to Severe Non-neurogenic Male Lower Urinary Tract Symptoms Receiving Tamsulosin Therapy
The aim of the study is to uses Prosta-OK® Neo that contains herb extracts including
 lycopene, phellinus linteus, pomegranate, pumpkin seed, selenium and zinc that have been
 demonstrated with functions of inhibiting 5-alpha reductase, antioxidant, anti-inflammation
 and regulating the synthesis of nitric oxide to explore whether Prosta-OK® can help reduce
 symptoms and elevate the quality of life in patients with mild to severe non-neurogenic male
 lower urinary tract symptoms receiving Tamsulosin therapy.
Lower urinary tract symptoms (LUTS) are kind of uncomfortable subjective feelings reported
 from patients and are divided into three groups, storage, voiding, and postmicturition
 symptoms. Many epidemiological studies have pointed out that the prevalence of LUTS among
 individuals aged at least 40 years in the United States, the United Kingdom, Sweden, China,
 Taiwan, and South Korea is up to 60%. LUTS may cause mental health disorders such as anxiety
 and depression and affect lifestyle that leads to a negative impact on the quality of life.
 In recent years, there have been numerous academic or clinical studies that assess the
 improvement of plant and herb extracts in LUTS.

 Prosta-OK® Neo is mainly comprised of herb extracts, including lycopene, phellinus linteus,
 pomegranate, pumpkin seed, selenium and zinc that have been demonstrated with functions of
 inhibiting 5-alpha reductase, antioxidant, anti-inflammation and regulating the synthesis of
 nitric oxide.

 The aim of the study is to explore whether take Prosta-OK® 2 tablets for 85 days compared
 with placebo group can help reduce symptoms and elevate the quality of life in patients with
 mild to severe non-neurogenic male LUTS receiving Tamsulosin therapy.
Inclusion Criteria:

 -  male between the ages of 30 and 55 when signing the informed consent form

 -  the subject was diagnosed with mild to severe non-neurogenic lower urinary tract
 symptoms and planed to receive Tamsulosin therapy

 -  the sum of International Prostate Symptom Score (IPSS) on questions 1 to 7 was 10
 points or higher

 -  the subject can take medication via oral or nasogastric tube confirmed with the
 function of absorption by the principal investigator or co-principal investigators

 -  the subject was willing to corporate study-related procedures and sign the informed
 consent form

 Exclusion Criteria:

 -  post-void residual urine volume greater than 200 mL or peak of maximum urine flow rate
 less than 5 mL/s

 -  total serum prostate-specific antigen higher than 10 ng/mL

 -  bladder outlet obstruction caused by reasons other than benign prostatic hyperplasia

 -  lower urinary tract symptoms caused by neurological disease such as Cerebrovascular
 Diseases, Parkinson's, dementia, Multiple Sclerosis (MS), spinal cord injuries (SCI),
 cauda equina syndrome, and Peripheral Neuropathy

 -  history or evidence of prostate cancer, male reproductive cancers, bladder cancer, and
 cancer of the ureter and urethra

 -  history or evidence of acute urinary retention (AUR)

 -  history or evidence of acute orthostatic hypotension

 -  with the urinary catheter or intermittent catheter

 -  stone in the urinary system

 -  Interstitial cystitis (IC), neurogenic bladder, overactive bladder (OAB) and
 Inflammatory Bowel Disease (IBD) within 3 mo prior to study entry

 -  chemotherapy or radiation therapy within 3 mo prior to study entry

 -  immunosuppressive therapy within 2 mo prior to study entry

 -  pelvic surgery or urinary surgery within 2 mo prior to study entry

 -  5-alpha-reductase inhibitors use within 6 mo prior to entry or alpha-1-adrenergic
 blockers use within 2 w prior to entry

 -  the subject plans to use medication other than Tamsulosin such as alpha-blocker,
 5-alpha-reductase inhibitors, antimuscarinic drugs, phosphodiesterase type 5 inhibitor
 (PDE5 inhibitors), Beta-3 agonists, desmopressin, diuretics, phenazopyridine, other
 drugs or foods are known to interact with tamsulosin and steroid or a nonsteroidal
 anti-inflammatory drug during participating in the study.

 -  the subject plans to receive cataract surgery during participating in the study or 1
 mo after participating in the study.

 -  the subject took other therapies such as acupuncture or phytotherapy, including Saw
 Palmetto, Pygeum Africanum, Hypoxis Rooperi, Rye-pollen extract, and Pumpkin Seed
 extract within 2 w prior to entry.

 -  the subject took Chinese herbs such as Soaring Dragon Decoction, Rehmannia Right
 Formula, Powder for Five Types of Painful Urinary Dysfunction, Minor Bupleurum
 Decoction, Artemisiae Scopariae Decoction, Decoction to Enrich Yin and Direct Fire
 Downward, Tonifies Qi、Coptis Decoction to Relieve Toxicity and related modifications,
 Radix Rehmanniae, Cortex Moutan, Radix Pulsatillae, Herba Taraxaci, Herba Portulacae,
 Fructus Forsythiae, Flos Lonicerae, Herba Lophatheri, Fructus Gardeniae, Phellinus
 linteus within 7 days prior to entry.

 -  have a history of allergy to the ingredients of investigational product

 -  Serum Glutamic-Oxaloacetic Transaminase and serum Glutamic-Pyruvic Transaminase were
 more than three times of normal range or Serum creatinine less than 1.5 mg/dL

 -  have a history of substance abuse within 2 yr prior to entry

 -  participating in any clinical trial such as health food, herbal extracts, and drug
 within 30 days prior to entry

 -  have other significant diseases and confirmed by the principal investigator as
 non-eligible to be enrolled in the study