NCT04418635

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

June 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 5, 2020

Status Verified

May 1, 2020

Enrollment Period

1.6 years

First QC Date

May 18, 2020

Last Update Submit

June 3, 2020

Conditions

Lower Urinary Tract Symptoms

Keywords

lower urinary tract symptomsInternational Prostate Symptom Scoretamsulosinadjunct therapyherbal extractionsdouble-blindrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • change in International Prostate Symptom Score from baseline on the sum of 1 to 7 questions

    compare the change in International Prostate Symptom Score from baseline between the experiment group and placebo group on the sum of 1 to 7 questions that are related to voiding symptoms. Scores of 0 to 7, 8 to 19, and 20 to 35 signify mild, moderate, and severe symptoms, respectively.

    day 1 (before receiving therapy) and day 85

Secondary Outcomes (8)

  • change in International Prostate Symptom Score on questions 1, 3, and 5 that are related to voiding symptoms, questions 2, 4, and 7 that are related to storage symptoms, and question 8 that is related to the quality of life from baseline

    day 1 (before receiving therapy) and day 85

  • change in International Prostate Symptom Score from baseline by visit on the sum of 1 to 7 questions that are related to voiding symptoms and question 8 that is related to the quality of life

    day 1 (before receiving therapy), day 15, day 29, and day 85

  • change in interleukin 6, interleukin 8, tumor necrosis factor-alpha and interleukin 1 beta levels in expressed prostatic secretion from baseline by visit

    day 1 (before receiving therapy), day 15, day 29, and day 85

  • change in maximum urinary flow rate from baseline.

    day 1 (before receiving therapy) and day 85

  • change in amount of post voiding residual urine from baseline.

    day 1 (before receiving therapy) and day 85

  • +3 more secondary outcomes

Study Arms (2)

Tamsulosin and Prosta-OK® Neo

EXPERIMENTAL

Tamsulosin 0.2mg once daily and Prosta-OK® Neo 707mg 2 tablets twice daily for 85 days

Dietary Supplement: Prosta-OK® Neo or Prosta-OK® Neo-matched placebo

Tamsulosin and Prosta-OK® Neo-matched placebo

PLACEBO COMPARATOR

Tamsulosin 0.2mg once daily and Prosta-OK® Neo-matched placebo 707mg 2 tablets twice daily for 85 days

Dietary Supplement: Prosta-OK® Neo or Prosta-OK® Neo-matched placebo

Interventions

Prosta-OK® Neo or Prosta-OK® Neo-matched placeboDIETARY_SUPPLEMENT

the patient planed to receive Tamsulosin 0.2mg once daily is randomized to the experiment group or placebo group. After randomization, the patient received Tamsulosin therapy with Prosta-OK® Neo or Prosta-OK® Neo-matched placebo 707mg 2 tablets twice daily for 85 days.

Tamsulosin and Prosta-OK® NeoTamsulosin and Prosta-OK® Neo-matched placebo

Eligibility Criteria

Age30 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiayi Chang Gung Memorial Hospital

Chiayi County, 613016, Taiwan

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dong-Ru HO, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Associate

CONTACT

+886-2-2249-1998acrobio64@acrobio.com.tw

Pharmacist

CONTACT

+886-2-2249-1998acrobio23@acrobio.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

June 5, 2020

Study Start

June 4, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 5, 2020

Record last verified: 2020-05

Locations

TW(1)