Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02313233
Recruitment Status : Completed
First Posted : December 10, 2014
Results First Posted : December 31, 2015
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Golden Biotechnology Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Benign Prostatic Hyperplasia
Interventions Dietary Supplement: Umooze
Dietary Supplement: Placebo
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Umooze Placebo
Hide Arm/Group Description

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. Umooze is given as add-on therapy for benigh prostate hyperplasia (BPH). All the subjects have the history for this medical condition and receive the medication. Each subject receives Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
Period Title: Overall Study
Started 20 21
Completed 18 18
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             1             2
Administrative reason             1             1
Arm/Group Title Umooze Placebo Total
Hide Arm/Group Description

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water. Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
The baseline analysis includes the International Prostate Symptom Score (IPSS), quality-of-life (QoL), urinary flow rate (Qmax), postvoided residual volume (PVR), prostate volume, serum PSA level. All the subjects have the history of benigh prostate hyperplasia and have been receiving the medication for this condition.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  61.1%
8
  44.4%
19
  52.8%
>=65 years
7
  38.9%
10
  55.6%
17
  47.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
18
 100.0%
18
 100.0%
36
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
18
 100.0%
18
 100.0%
36
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 18 participants 18 participants 36 participants
18 18 36
Internation Prostate Symptom Score (IPSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
13.22  (6.26) 19.5  (8.03) 16.36  (7.67)
[1]
Measure Description: The international prostate symptom score (IPSS) is a validated 7- item urinary symptom severity scale. The answers are assigned from 0 to 5, indicating increasing severity. The total score therefore ranges from 0 to 35 points (asymptomatic to symptomatic). Patients can be classified as follows: <=7 is mildly symptomatic; 8~ 19 is moderately symptomatic; 20~ 35 is severely symptomatic.
Quality-of-Life   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 18 participants 18 participants 36 participants
3.33  (1.50) 3.78  (1.22) 3.56  (1.34)
[1]
Measure 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.
Uroflowmetry (UFR) measure of maximum flow rate (Qmax)   [1] 
Mean (Standard Deviation)
Unit of measure:  Ml/ sec
Number Analyzed 18 participants 18 participants 36 participants
11.5  (2.88) 10.23  (3.71) 10.85  (3.29)
[1]
Measure Description: Urine flow rate is a measure of the quantity of urine excreted. Qmax is an indicator to diagnose the enlarged prostate. A lower Qmax may relate to the pressure on the urethra by the enlarged prostate.
Postvoid Residual Volume (PVR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Ml
Number Analyzed 18 participants 18 participants 36 participants
43.7  (27.6) 52.4  (67.0) 48.06  (50.00)
[1]
Measure Description: This PVR test measures the quantity of urine remained in the bladder after urination. This test is helpful to evaluate the existence of urination problems including an enlarged prostate (BPH).
Prostate volume   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm^3
Number Analyzed 18 participants 18 participants 36 participants
37.2  (20.1) 39.5  (16.9) 39.10  (18.51)
[1]
Measure Description: The measurement of prostate volume is used to diagnose an abnormal enlargement of the prostate. Abnormally enlarged prostate may be caused by inflammation or viral infection.
Serum Total Prostate-Specific Antigen level (PSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Nanograms/ ml
Number Analyzed 18 participants 18 participants 36 participants
1.54  (1.34) 1.95  (1.31) 1.74  (1.31)
[1]
Measure Description: The prostate- specific antigen (PSA) is a protein produced by the prostate gland. This test is utilized to evaluate the presence of prostate hyperplasia if a rise of PSA level detected in a man's blood.
Different original medications and dosages   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Harnalidge® 0.4 mg QD treatment 11 11 22
Harnalidge® 0.2 mg QD treatment 2 3 5
Harnalidge® 0.1 mg QD treatment 1 0 1
Doxaben® 4 mg QD treatment 2 2 4
Doxaben® XL 4 mg QD treatment 2 2 4
[1]
Measure Description: The study product (Umooze or placebo) is given as add-on therapy in BPH, therefore the evaluation of benefit may be affected by the original medication.
1.Primary Outcome
Title International Prostate Symptom Score (IPSS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
For all subjects' medical histories in this study, there are one subject receiving Hatnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.
Arm/Group Title Umooze Placebo
Hide Arm/Group Description:

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
International prostate symptom score 9.83  (4.48) 13.6  (6.88)
Difference in IPSS between V1 and V6 -3.39  (6.11) -5.94  (8.11)
2.Primary Outcome
Title Quality- Of- Life Index (QoL)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Hatnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment
Arm/Group Title Umooze Placebo
Hide Arm/Group Description:

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Quality-of-Life (QoL) 2.72  (1.07) 3.22  (1.17)
Difference of QoL between V1 and V6 -0.61  (1.20) -0.56  (1.20)
3.Primary Outcome
Title International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All these five subjects in this statistical result have been treated BPH with 0.4 mg of Harnalidge for more than 12 months.
Arm/Group Title Umooze Placebo
Hide Arm/Group Description:

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
Overall Number of Participants Analyzed 2 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
International prostate symptom score 11.00  (4.24) 14.33  (3.21)
Difference in IPSS between V1 and V6 -9.50  (3.54) -4.33  (1.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Umooze, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
4.Primary Outcome
Title Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All these twenty-two subjects included in this statistical result have been received 0.4 mg Harnalidge for BPH treatment.
Arm/Group Title Umooze Placebo
Hide Arm/Group Description:

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of the study product was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Quality of Life (QoL) 2.73  (1.10) 3.27  (1.10)
Difference of QoL between V1 and V6 -0.82  (0.87) -0.09  (0.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Umooze, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
5.Secondary Outcome
Title Maximum Flow Rate (Qmax)
Hide Description It's used to determine the degree of urinary difficulty.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment.
Arm/Group Title Umooze Placebo
Hide Arm/Group Description:

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ml/ sec
Qmax 14.4  (4.29) 12.72  (6.57)
Difference of Qmax between V1 and V6 2.88  (3.77) 2.49  (5.46)
6.Secondary Outcome
Title Postvoid Residual Volume (PVR)
Hide Description The PVR urine test measures the amount of urine left in the bladder after urination.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receivingHarnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.
Arm/Group Title Umooze Placebo
Hide Arm/Group Description:

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ml
Post- Void Residual Volume (PVR) 35.3  (35.9) 67.2  (47.8)
Difference of PVR between V1 and V6 -8.39  (31.9) 14.8  (32.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Umooze, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
7.Secondary Outcome
Title Prostate Volume
Hide Description It's related to progression of benign prostatic hyperplasia (BPH).
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.
Arm/Group Title Umooze Placebo
Hide Arm/Group Description:

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: cm^3
Prostate Volume 29.1  (11.5) 38.2  (20.1)
Difference of prostate volume between V1 and V6 -8.17  (12.7) -1.33  (7.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Umooze, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
8.Secondary Outcome
Title Prostate-specific Antigen (PSA) Level
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.
Arm/Group Title Umooze Placebo
Hide Arm/Group Description:

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: ng/ml
Prostate- specific Antigen (PSA) 1.67  (1.34) 2.22  (1.69)
Difference of PSA between V1 and V6 0.14  (0.32) 0.26  (0.76)
Time Frame 56 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Umooze Placebo
Hide Arm/Group Description

Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg

Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. 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. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water.

Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
All-Cause Mortality
Umooze Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Umooze Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Umooze Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/20 (10.00%)      2/21 (9.52%)    
Cardiac disorders     
Hypertension * [1]  0/20 (0.00%)  0 1/21 (4.76%)  1
Immune system disorders     
Rush * [2]  2/20 (10.00%)  2 1/21 (4.76%)  2
Nervous system disorders     
Insomnia * [3]  0/20 (0.00%)  0 1/21 (4.76%)  2
*
Indicates events were collected by non-systematic assessment
[1]
It happened to only one subject in the placebo group. This subject got it mild and has been withdrawn.
[2]
This event took place in both umooze and placebo groups, one subject in placebo group and two subjects in umooze group. Rush on these three affected subjects was mild. There was one subject of them was withdrawn from the placebo group.
[3]
Insomnia happened to only one subject who has been withdrawn from this study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ching- Chia Li
Organization: Kaohsiung Municipal TA- TUNG Hospital
Phone: 886-7-291-1101
Publications:
Layout table for additonal information
Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT02313233    
Other Study ID Numbers: IRC01110908
First Submitted: December 5, 2014
First Posted: December 10, 2014
Results First Submitted: September 3, 2015
Results First Posted: December 31, 2015
Last Update Posted: June 21, 2016