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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umooze | Experimental | Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extracts 20 mg |
|
| Placebo | Placebo Comparator | Cornstarch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umooze | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 56 days |
| 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. | 56 days |
| 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. | 56 days |
| 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. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Flow Rate (Qmax) | It's used to determine the degree of urinary difficulty. | 56 days |
| Postvoid Residual Volume (PVR) | The PVR urine test measures the amount of urine left in the bladder after urination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ching- Chia Li, M.D | Kaohsiung Municipal Ta-Tung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Municipal TA- TUNG Hospital | Kaohsiung City | 80145 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21073697 | Background | 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. | |
| 17536892 | Background | 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. doi: 10.2165/00044011-200323120-00003. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
56 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | Non-systematic Assessment | Insomnia happened to only one subject who has been withdrawn from this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ching- Chia Li | Kaohsiung Municipal TA- TUNG Hospital | 886-7-291-1101 |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| Placebo | Dietary Supplement | Placebo is consisted of cornstarch and is provided by by Golden Biotechnology Corp. |
|
| 56 days |
| Prostate Volume | It's related to progression of benign prostatic hyperplasia (BPH). | 56 days |
| 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. | 56 days |
| 11507733 | Background | 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. doi: 10.1002/ptr.769. |
| 12678210 | Background | 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. doi: 10.3949/ccjm.70.3.203. |
| 10999046 | Background | 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. doi: 10.1080/07357909909011714. |
| 12679907 | Background | 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. doi: 10.3748/wjg.v9.i4.670. |
| 16571087 | Background | 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. doi: 10.1089/thy.2006.16.249. |
| 10828668 | Background | 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. doi: 10.1159/000020218. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Internation Prostate Symptom Score (IPSS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Quality-of-Life | The QoL index is a single question with scores of 0-6 point and corresponding to the assessment index ranging from delighted to terrible. | Mean | Standard Deviation | units on a scale |
|
| Uroflowmetry (UFR) measure of maximum flow rate (Qmax) | 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. | Mean | Standard Deviation | ml/ sec |
|
| Postvoid Residual Volume (PVR) | 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). | Mean | Standard Deviation | ml |
|
| Prostate volume | 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. | Mean | Standard Deviation | cm^3 |
|
| Serum Total Prostate-Specific Antigen level (PSA) | 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. | Mean | Standard Deviation | nanograms/ ml |
|
| Different original medications and dosages | 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. | Number | participants |
|
| OG001 | Placebo | 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. |
|
|
| Secondary | Maximum Flow Rate (Qmax) | It's used to determine the degree of urinary difficulty. | 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. | Posted | Mean | Standard Deviation | ml/ sec | 56 days |
|
|
|
| Secondary | Postvoid Residual Volume (PVR) | The PVR urine test measures the amount of urine left in the bladder after urination. | 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. | Posted | Mean | Standard Deviation | ml | 56 days |
|
|
|
|
| Secondary | Prostate Volume | It's related to progression of benign prostatic hyperplasia (BPH). | 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. | Posted | Mean | Standard Deviation | cm^3 | 56 days |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | ng/ml | 56 days |
|
|
|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
| Primary | 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. | All these five subjects in this statistical result have been treated BPH with 0.4 mg of Harnalidge for more than 12 months. | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
|
| Primary | 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. | All these twenty-two subjects included in this statistical result have been received 0.4 mg Harnalidge for BPH treatment. | Posted | Mean | Standard Deviation | units on a scale | 56 days |
|
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | 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. | 0 | 21 | 2 | 21 |
|
| Rush | Immune system disorders | Non-systematic Assessment | 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. |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment | It happened to only one subject in the placebo group. This subject got it mild and has been withdrawn. |
|
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| D052801 |
| Male Urogenital Diseases |