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

• Sponsor: Golden Biotechnology Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02313233
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Dietary Supplement: Umooze; Dietary Supplement: Placebo	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Research on Benefit of Umooze as Add-on Therapy in Benign Prostatic Hyperplasia
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Umooze Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extracts 20 mg	Dietary Supplement: Umooze; 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.
Placebo Comparator: Placebo Cornstarch.	Dietary Supplement: Placebo; Placebo is consisted of cornstarch and is provided by by Golden Biotechnology Corp.

Outcome Measures

Primary Outcome Measures

1. International Prostate Symptom Score (IPSS) [56 days]

   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.

2. Quality- Of- Life Index (QoL) [56 days]

   The QoL index is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.

3. International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months [56 days]

   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.

4. Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge [56 days]

   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

1. Maximum Flow Rate (Qmax) [56 days]

   It's used to determine the degree of urinary difficulty.

2. Postvoid Residual Volume (PVR) [56 days]

   The PVR urine test measures the amount of urine left in the bladder after urination.

3. Prostate Volume [56 days]

   It's related to progression of benign prostatic hyperplasia (BPH).

4. Prostate-specific Antigen (PSA) Level [56 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Municipal TA- TUNG Hospital	Kaohsiung City		Taiwan	80145

Sponsors and Collaborators

• Golden Biotechnology Corporation

Investigators

• Principal Investigator: Ching- Chia Li, M.D, Kaohsiung Municipal Ta-Tung Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Angalakuditi M, Seifert RF, Hayes RP, O'Leary MP, Viktrup L. Measurement properties of the benign prostatic hyperplasia impact index in tadalafil studies. Health Qual Life Outcomes. 2010 Nov 12;8:131. doi: 10.1186/1477-7525-8-131.
• Gaynor ML. Isoflavones and the prevention and treatment of prostate disease: is there a role? Cleve Clin J Med. 2003 Mar;70(3):203-4, 206, 208-9 passim. Review.
• Kurashige S, Akuzawa Y, Endo F. Effects of astragali radix extract on carcinogenesis, cytokine production, and cytotoxicity in mice treated with a carcinogen, N-butyl-N'-butanolnitrosoamine. Cancer Invest. 1999;17(1):30-5.
• Li NC, Chen S, Yang XH, Du LD, Wang JY, Na YQ; Beijing Tamsulosin Study Group. Efficacy of low-dose tamsulosin in chinese patients with symptomatic benign prostatic hyperplasia. Clin Drug Investig. 2003;23(12):781-7.
• Lin J, Dong HF, Oppenheim JJ, Howard OM. Effects of astragali radix on the growth of different cancer cell lines. World J Gastroenterol. 2003 Apr;9(4):670-3.
• Messina M, Redmond G. Effects of soy protein and soybean isoflavones on thyroid function in healthy adults and hypothyroid patients: a review of the relevant literature. Thyroid. 2006 Mar;16(3):249-58. Review.
• Safety, efficacy and impact on Patients' quality of life of a long-term treatment with the alpha(1)-blocker alfuzosin in symptomatic patients with BPH. The Italian Alfuzosin Co-Operative Group. Eur Urol. 2000 Jun;37(6):680-6.
• Upadhyay L, Tripathi K, Kulkarni KS. A study of prostane in the treatment of benign prostatic hyperplasia. Phytother Res. 2001 Aug;15(5):411-5.

• Responsible Party: Golden Biotechnology Corporation
• ClinicalTrials.gov Identifier: NCT02313233
• Other Study ID Numbers: IRC01110908
• First Posted: Dec 10, 2014
• Last Update Posted: Jun 21, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

Participant Flow

Arm/Group Title	Umooze	Placebo
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

Baseline Characteristics

Arm/Group Title	Umooze	Placebo	Total
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 Participants	18	18	36
Age (Count of Participants)
<=18 years	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 (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	18 100%	18 100%	36 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	18 100%	18 100%	36 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Taiwan	18 100%	18 100%	36 100%
Internation Prostate Symptom Score (IPSS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	13.22 (6.26)	19.5 (8.03)	16.36 (7.67)
Quality-of-Life (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.33 (1.50)	3.78 (1.22)	3.56 (1.34)
Uroflowmetry (UFR) measure of maximum flow rate (Qmax) (ml/ sec) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/ sec]	11.5 (2.88)	10.23 (3.71)	10.85 (3.29)
Postvoid Residual Volume (PVR) (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	43.7 (27.6)	52.4 (67.0)	48.06 (50.00)
Prostate volume (cm^3) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm^3]	37.2 (20.1)	39.5 (16.9)	39.10 (18.51)
Serum Total Prostate-Specific Antigen level (PSA) (nanograms/ ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [nanograms/ ml]	1.54 (1.34)	1.95 (1.31)	1.74 (1.31)
Different original medications and dosages (participants) [Number]
Harnalidge® 0.4 mg QD treatment	11 61.1%	11 61.1%	22 61.1%
Harnalidge® 0.2 mg QD treatment	2 11.1%	3 16.7%	5 13.9%
Harnalidge® 0.1 mg QD treatment	1 5.6%	0 0%	1 2.8%
Doxaben® 4 mg QD treatment	2 11.1%	2 11.1%	4 11.1%
Doxaben® XL 4 mg QD treatment	2 11.1%	2 11.1%	4 11.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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
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.
Measure Participants	18	18
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. Secondary Outcome

Title	Maximum Flow Rate (Qmax)
Description	It's used to determine the degree of urinary difficulty.
Time Frame	56 days

Outcome Measure Data

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
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.
Measure Participants	18	18
Qmax	14.4 (4.29)	12.72 (6.57)
Difference of Qmax between V1 and V6	2.88 (3.77)	2.49 (5.46)

3. Secondary Outcome

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

Outcome Measure Data

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
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.
Measure Participants	18	18
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umooze, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 1 sided
	Comments

4. Secondary Outcome

Title	Prostate Volume
Description	It's related to progression of benign prostatic hyperplasia (BPH).
Time Frame	56 days

Outcome Measure Data

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
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.
Measure Participants	18	18
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umooze, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 1 sided
	Comments

5. Secondary Outcome

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

Outcome Measure Data

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
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.
Measure Participants	18	18
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)

6. Primary Outcome

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

Outcome Measure Data

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
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.
Measure Participants	18	18
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)

7. Primary Outcome

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

Outcome Measure Data

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
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.
Measure Participants	2	3
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umooze, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 1 sided
	Comments

8. Primary Outcome

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

Outcome Measure Data

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
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.
Measure Participants	11	11
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Umooze, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	56 days
Arm/Group Title	Umooze		Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Umooze		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Umooze		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		2/21 (9.5%)
Cardiac disorders
Hypertension	0/20 (0%)	0	1/21 (4.8%)	1
Immune system disorders
Rush	2/20 (10%)	2	1/21 (4.8%)	2
Nervous system disorders
Insomnia	0/20 (0%)	0	1/21 (4.8%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.