Trial Outcomes & Findings for Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia (NCT NCT02313233)
NCT ID: NCT02313233
Last Updated: 2016-06-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
56 days
Results posted on
2016-06-21
Participant Flow
Participant milestones
| Measure |
Umooze
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.
|
Placebo
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Umooze
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.
|
Placebo
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Administrative reason
|
1
|
1
|
Baseline Characteristics
Research on Benefit of Umooze as Add- on Therapy in Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Umooze
n=18 Participants
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.
|
Placebo
n=18 Participants
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
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Internation Prostate Symptom Score (IPSS)
|
13.22 units on a scale
STANDARD_DEVIATION 6.26 • n=5 Participants
|
19.5 units on a scale
STANDARD_DEVIATION 8.03 • n=7 Participants
|
16.36 units on a scale
STANDARD_DEVIATION 7.67 • n=5 Participants
|
|
Quality-of-Life
|
3.33 units on a scale
STANDARD_DEVIATION 1.50 • n=5 Participants
|
3.78 units on a scale
STANDARD_DEVIATION 1.22 • n=7 Participants
|
3.56 units on a scale
STANDARD_DEVIATION 1.34 • n=5 Participants
|
|
Uroflowmetry (UFR) measure of maximum flow rate (Qmax)
|
11.5 ml/ sec
STANDARD_DEVIATION 2.88 • n=5 Participants
|
10.23 ml/ sec
STANDARD_DEVIATION 3.71 • n=7 Participants
|
10.85 ml/ sec
STANDARD_DEVIATION 3.29 • n=5 Participants
|
|
Postvoid Residual Volume (PVR)
|
43.7 ml
STANDARD_DEVIATION 27.6 • n=5 Participants
|
52.4 ml
STANDARD_DEVIATION 67.0 • n=7 Participants
|
48.06 ml
STANDARD_DEVIATION 50.00 • n=5 Participants
|
|
Prostate volume
|
37.2 cm^3
STANDARD_DEVIATION 20.1 • n=5 Participants
|
39.5 cm^3
STANDARD_DEVIATION 16.9 • n=7 Participants
|
39.10 cm^3
STANDARD_DEVIATION 18.51 • n=5 Participants
|
|
Serum Total Prostate-Specific Antigen level (PSA)
|
1.54 nanograms/ ml
STANDARD_DEVIATION 1.34 • n=5 Participants
|
1.95 nanograms/ ml
STANDARD_DEVIATION 1.31 • n=7 Participants
|
1.74 nanograms/ ml
STANDARD_DEVIATION 1.31 • n=5 Participants
|
|
Different original medications and dosages
Harnalidge® 0.4 mg QD treatment
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Different original medications and dosages
Harnalidge® 0.2 mg QD treatment
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Different original medications and dosages
Harnalidge® 0.1 mg QD treatment
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Different original medications and dosages
Doxaben® 4 mg QD treatment
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Different original medications and dosages
Doxaben® XL 4 mg QD treatment
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 56 daysPopulation: 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.
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.
Outcome measures
| Measure |
Umooze
n=18 Participants
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.
|
Placebo
n=18 Participants
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.
|
|---|---|---|
|
International Prostate Symptom Score (IPSS)
International prostate symptom score
|
9.83 units on a scale
Standard Deviation 4.48
|
13.6 units on a scale
Standard Deviation 6.88
|
|
International Prostate Symptom Score (IPSS)
Difference in IPSS between V1 and V6
|
-3.39 units on a scale
Standard Deviation 6.11
|
-5.94 units on a scale
Standard Deviation 8.11
|
PRIMARY outcome
Timeframe: 56 daysPopulation: 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
The QoL index is a single question with scores of 0\~6 point and corresponding to the assessment index ranging from delighted to terrible.
Outcome measures
| Measure |
Umooze
n=18 Participants
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.
|
Placebo
n=18 Participants
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.
|
|---|---|---|
|
Quality- Of- Life Index (QoL)
Quality-of-Life (QoL)
|
2.72 units on a scale
Standard Deviation 1.07
|
3.22 units on a scale
Standard Deviation 1.17
|
|
Quality- Of- Life Index (QoL)
Difference of QoL between V1 and V6
|
-0.61 units on a scale
Standard Deviation 1.20
|
-0.56 units on a scale
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: 56 daysPopulation: All these five subjects in this statistical result have been treated BPH with 0.4 mg of Harnalidge 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.
Outcome measures
| Measure |
Umooze
n=2 Participants
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.
|
Placebo
n=3 Participants
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.
|
|---|---|---|
|
International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
International prostate symptom score
|
11.00 units on a scale
Standard Deviation 4.24
|
14.33 units on a scale
Standard Deviation 3.21
|
|
International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
Difference in IPSS between V1 and V6
|
-9.50 units on a scale
Standard Deviation 3.54
|
-4.33 units on a scale
Standard Deviation 1.53
|
PRIMARY outcome
Timeframe: 56 daysPopulation: All these twenty-two subjects included in this statistical result have been received 0.4 mg Harnalidge for BPH treatment.
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.
Outcome measures
| Measure |
Umooze
n=11 Participants
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.
|
Placebo
n=11 Participants
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.
|
|---|---|---|
|
Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
Quality of Life (QoL)
|
2.73 units on a scale
Standard Deviation 1.10
|
3.27 units on a scale
Standard Deviation 1.10
|
|
Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
Difference of QoL between V1 and V6
|
-0.82 units on a scale
Standard Deviation 0.87
|
-0.09 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: 56 daysPopulation: 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.
It's used to determine the degree of urinary difficulty.
Outcome measures
| Measure |
Umooze
n=18 Participants
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.
|
Placebo
n=18 Participants
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.
|
|---|---|---|
|
Maximum Flow Rate (Qmax)
Qmax
|
14.4 ml/ sec
Standard Deviation 4.29
|
12.72 ml/ sec
Standard Deviation 6.57
|
|
Maximum Flow Rate (Qmax)
Difference of Qmax between V1 and V6
|
2.88 ml/ sec
Standard Deviation 3.77
|
2.49 ml/ sec
Standard Deviation 5.46
|
SECONDARY outcome
Timeframe: 56 daysPopulation: 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.
The PVR urine test measures the amount of urine left in the bladder after urination.
Outcome measures
| Measure |
Umooze
n=18 Participants
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.
|
Placebo
n=18 Participants
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.
|
|---|---|---|
|
Postvoid Residual Volume (PVR)
Post- Void Residual Volume (PVR)
|
35.3 ml
Standard Deviation 35.9
|
67.2 ml
Standard Deviation 47.8
|
|
Postvoid Residual Volume (PVR)
Difference of PVR between V1 and V6
|
-8.39 ml
Standard Deviation 31.9
|
14.8 ml
Standard Deviation 32.8
|
SECONDARY outcome
Timeframe: 56 daysPopulation: 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.
It's related to progression of benign prostatic hyperplasia (BPH).
Outcome measures
| Measure |
Umooze
n=18 Participants
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.
|
Placebo
n=18 Participants
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.
|
|---|---|---|
|
Prostate Volume
Prostate Volume
|
29.1 cm^3
Standard Deviation 11.5
|
38.2 cm^3
Standard Deviation 20.1
|
|
Prostate Volume
Difference of prostate volume between V1 and V6
|
-8.17 cm^3
Standard Deviation 12.7
|
-1.33 cm^3
Standard Deviation 7.36
|
SECONDARY outcome
Timeframe: 56 daysPopulation: 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.
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.
Outcome measures
| Measure |
Umooze
n=18 Participants
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.
|
Placebo
n=18 Participants
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.
|
|---|---|---|
|
Prostate-specific Antigen (PSA) Level
Prostate- specific Antigen (PSA)
|
1.67 ng/ml
Standard Deviation 1.34
|
2.22 ng/ml
Standard Deviation 1.69
|
|
Prostate-specific Antigen (PSA) Level
Difference of PSA between V1 and V6
|
0.14 ng/ml
Standard Deviation 0.32
|
0.26 ng/ml
Standard Deviation 0.76
|
Adverse Events
Umooze
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Umooze
n=20 participants at risk
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.
|
Placebo
n=21 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Insomnia
|
0.00%
0/20 • 56 days
|
4.8%
1/21 • Number of events 2 • 56 days
|
|
Immune system disorders
Rush
|
10.0%
2/20 • Number of events 2 • 56 days
|
4.8%
1/21 • Number of events 2 • 56 days
|
|
Cardiac disorders
Hypertension
|
0.00%
0/20 • 56 days
|
4.8%
1/21 • Number of events 1 • 56 days
|
Additional Information
Dr. Ching- Chia Li
Kaohsiung Municipal TA- TUNG Hospital
Phone: 886-7-291-1101
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER