Benign Prostatic HyperplasiaNCT02313233

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

A study testing Umooze in people with Benign Prostatic Hyperplasia, run by Golden Biotechnology Corporation at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: Umooze
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 1 siteTaiwan
Study dates: Dec 2013to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Kaohsiung Municipal TA- TUNG Hospital
Kaohsiung City, 80145

Other trials in Taiwan

About this study

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

Read the 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).

Conditions: Benign Prostatic Hyperplasia
Being tested: Umooze, Placebo
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UmoozeDietary 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.
PlaceboDietary supplement
Placebo is consisted of cornstarch and is provided by by Golden Biotechnology Corp.

Study groups in NCT02313233
Study group	Role	What they receive
Umooze	Experimental	Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extracts 20 mg Receives: Dietary Supplement: Umooze
Placebo	Placebo comparator	Cornstarch. Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 56 days

Secondary outcomes (4)

Maximum Flow Rate (Qmax)
It's used to determine the degree of urinary difficulty.
Measured: 56 days
Postvoid Residual Volume (PVR)
The PVR urine test measures the amount of urine left in the bladder after urination.
Measured: 56 days
Prostate Volume
It's related to progression of benign prostatic hyperplasia (BPH).
Measured: 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.
Measured: 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013May 2015

First posted10 Dec 2014 (estimated)
Study startDec 2013
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02313233
Sponsor's protocol ID: IRC01110908
Status last verified: May 2016
First submitted: 5 Dec 2014
Last updated: 21 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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.
PubMed 21073697
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.
PubMed 17536892
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.
PubMed 11507733
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.
PubMed 12678210
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.
PubMed 10999046
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.
PubMed 12679907
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.
PubMed 16571087
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.
PubMed 10828668

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Research on Benefit of Umooze as Add-on Therapy in Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT02313233
Acronym / sponsor ID: IRC01110908
Conditions: Benign Prostatic Hyperplasia
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Golden Biotechnology CorporationIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 10 Dec 2014 (estimated)
Results: Posted 31 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Umooze	Experimental	Dietary Supplement: UmoozeTablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extracts 20 mg
Placebo	Placebo comparator	Dietary Supplement: PlaceboCornstarch.

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UmoozeUmooze 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.	Dietary supplement	Umooze
PlaceboPlacebo is consisted of cornstarch and is provided by by Golden Biotechnology Corp.	Dietary supplement	Placebo

Primary outcome

International Prostate Symptom Score (IPSS)
Time frame: 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.
Quality- Of- Life Index (QoL)
Time frame: 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.
International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
Time frame: 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.
Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
Time frame: 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.

4 secondary outcomes

Maximum Flow Rate (Qmax)
Time frame: 56 days
Postvoid Residual Volume (PVR)
Time frame: 56 days
Prostate Volume
Time frame: 56 days
Prostate-specific Antigen (PSA) Level
Time frame: 56 days

Results and safety

Results posted to the registry on 31 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Umooze	20	18
Placebo	21	18

Primary outcome: International Prostate Symptom Score (IPSS)

Time frame: 56 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Umooze n = 18	Placebo n = 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)

Population analysed: 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.

Primary outcome: Quality- Of- Life Index (QoL)

Time frame: 56 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Umooze n = 18	Placebo n = 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)

Population analysed: 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

Primary outcome: International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months

Time frame: 56 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Umooze n = 2	Placebo n = 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)

Umooze vs Placebo: p <0.05, t-test, 1 sided

Population analysed: All these five subjects in this statistical result have been treated BPH with 0.4 mg of Harnalidge for more than 12 months.

Primary outcome: Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge

Time frame: 56 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Umooze n = 11	Placebo n = 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)

Umooze vs Placebo: p <0.05, t-test, 1 sided

Population analysed: All these twenty-two subjects included in this statistical result have been received 0.4 mg Harnalidge for BPH treatment.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 56 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Umooze	0 of 20 (0%)	2 of 20 (10%)	Not reported
Placebo	0 of 21 (0%)	2 of 21 (9.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21073697Angalakuditi 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.
Background: PubMed 17536892Li 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.
Background: PubMed 11507733Upadhyay 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.
Background: PubMed 12678210Gaynor 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.
Background: PubMed 10999046Kurashige 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.
Background: PubMed 12679907Lin 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.
Background: PubMed 16571087Messina 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.
Background: PubMed 10828668Safety, 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.
Individual participant dataSharing planned: No

Related trials for Benign Prostatic Hyperplasia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ching- Chia Li, M.D principal investigator

Kaohsiung Municipal Ta-Tung Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Umooze in people with Benign Prostatic Hyperplasia, run by Golden Biotechnology Corporation at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Prostate Symptom Score (IPSS) (time frame: 56 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02313233, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.