Back to resultsResearch on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Umooze
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Males aged >=40 years old
- Screened by inquiry and diagnosed as BPH based on the result of a digital rectal examination (DRE) or transrectal ultrasonography (TRUS)
- Prostate volume >= 20 cm3
- Has complained of voiding symptoms related to BPH
- Has an IPSS >= 13 or an UFR measure of Qmax <= 15 ml/sec together with a voided volume >= 150 ml.
- Serum PSA < 6.5 ng/ml
- Has been treated with medication for BPH
- Informed consent form signed.
Exclusion Criteria:
- Sensitivity to study product
- Had received prostatic surgery for BPH during the past 24 weeks
- Hard nodule found by DRE
- Ongoing neurogenic bladder, urinary tract infection, bladder stone, urethral stricture, bladder cancer, prostate cancer, severe liver dysfunction, severe renal dysfunction or severe cardiovascular disease.
- Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co- investigator.
- Participation of any clinical investigation during the last 30 days.
- Individuals are judged by the investigators or co- investigator to be undesirable as subjects.
Sites / Locations
- Kaohsiung Municipal TA- TUNG Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Umooze
Placebo
Arm Description
Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extracts 20 mg
Cornstarch.
Outcomes
Primary Outcome Measures
International Prostate Symptom Score (IPSS)
It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Quality- Of- Life Index (QoL)
The QoL index is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.
International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
The Quality of Life (QoL) is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.
Secondary Outcome Measures
Maximum Flow Rate (Qmax)
It's used to determine the degree of urinary difficulty.
Postvoid Residual Volume (PVR)
The PVR urine test measures the amount of urine left in the bladder after urination.
Prostate Volume
It's related to progression of benign prostatic hyperplasia (BPH).
Prostate-specific Antigen (PSA) Level
Serum PSA test measures the amount of prostate- specific antigen in the blood. As a man's prostate enlarges with age, the amount of PSA in the blood normally increases.
Full Information
NCT ID
NCT02313233
First Posted
December 5, 2014
Last Updated
May 17, 2016
Sponsor
Golden Biotechnology Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02313233
Brief Title
Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia
Official Title
Research on Benefit of Umooze as Add-on Therapy in Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Golden Biotechnology Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the improvement in symptoms of Benign Prostatic Hyperplasia (BPH) according to the Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze twice daily administration for 56 days in patients with BPH.
Detailed Description
The study product, Umooze, contain Astragalus radix extracts and Soy extracts as the combination of 960:40 in one 500 mg tablet. Umooze is sold in the market as food. The objective of this study is to evaluate the benefit of Umooze as add- on therapy in BPH, by evaluation the improvement in symptoms of BPH assessed according to the International Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze in patients with BPH. The IPSS is a validated 7-item urinary symptom severity scale.
A randomized, two-regimen, placebo-controlled, parallel- design is used in this study in which each subject will receive Umooze or placebo. The add- on study product will be administered twice daily for 56 days. Benefit will be evaluated at baseline and subsequently on the study day 28, 42, and 56, such as IPSS index, QoL index, Qmax, PVR, prostate volume and Prostate-specific antigen(PSA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umooze
Arm Type
Experimental
Arm Description
Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extracts 20 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cornstarch.
Intervention Type
Dietary Supplement
Intervention Name(s)
Umooze
Intervention Description
Umooze is consisted of Astragalus radix extracts and soy extracts. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo is consisted of cornstarch and is provided by by Golden Biotechnology Corp.
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS)
Description
It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Time Frame
56 days
Title
Quality- Of- Life Index (QoL)
Description
The QoL index is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.
Time Frame
56 days
Title
International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
Description
It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Time Frame
56 days
Title
Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
Description
The Quality of Life (QoL) is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Maximum Flow Rate (Qmax)
Description
It's used to determine the degree of urinary difficulty.
Time Frame
56 days
Title
Postvoid Residual Volume (PVR)
Description
The PVR urine test measures the amount of urine left in the bladder after urination.
Time Frame
56 days
Title
Prostate Volume
Description
It's related to progression of benign prostatic hyperplasia (BPH).
Time Frame
56 days
Title
Prostate-specific Antigen (PSA) Level
Description
Serum PSA test measures the amount of prostate- specific antigen in the blood. As a man's prostate enlarges with age, the amount of PSA in the blood normally increases.
Time Frame
56 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males aged >=40 years old
Screened by inquiry and diagnosed as BPH based on the result of a digital rectal examination (DRE) or transrectal ultrasonography (TRUS)
Prostate volume >= 20 cm3
Has complained of voiding symptoms related to BPH
Has an IPSS >= 13 or an UFR measure of Qmax <= 15 ml/sec together with a voided volume >= 150 ml.
Serum PSA < 6.5 ng/ml
Has been treated with medication for BPH
Informed consent form signed.
Exclusion Criteria:
Sensitivity to study product
Had received prostatic surgery for BPH during the past 24 weeks
Hard nodule found by DRE
Ongoing neurogenic bladder, urinary tract infection, bladder stone, urethral stricture, bladder cancer, prostate cancer, severe liver dysfunction, severe renal dysfunction or severe cardiovascular disease.
Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co- investigator.
Participation of any clinical investigation during the last 30 days.
Individuals are judged by the investigators or co- investigator to be undesirable as subjects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching- Chia Li, M.D
Organizational Affiliation
Kaohsiung Municipal Ta-Tung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Municipal TA- TUNG Hospital
City
Kaohsiung City
ZIP/Postal Code
80145
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia
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