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CompletedNCT02313233Updated Jun 21, 2016Results posted

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

An interventional study of Umooze and Placebo in Benign Prostatic Hyperplasia, sponsored by Golden Biotechnology Corporation. Completed at 1 site in Taiwan. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-06-21.

Sponsored by Golden Biotechnology Corporation · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
40 Years and older
Sex
Male
01

Study 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 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).

02

Conditions studied

  • Benign Prostatic Hyperplasia

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03

In context

Prostatic Hyperplasia

803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 41 is below the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Golden Biotechnology Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Umooze

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

    Dietary Supplement: Umooze

  • Placebo comparator
    Placebo

    Cornstarch.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementUmooze

    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.

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 56 days

  2. 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.

    Time frame: 56 days

  3. 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.

    Time frame: 56 days

  4. 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.

    Time frame: 56 days

Secondary outcomes

  1. Maximum Flow Rate (Qmax)

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

    Time frame: 56 days

  2. Postvoid Residual Volume (PVR)

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

    Time frame: 56 days

  3. Prostate Volume

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

    Time frame: 56 days

  4. 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.

    Time frame: 56 days

07

Results

Posted Dec 31, 2015

Participant flow

Participant flow — Overall Study
MilestoneUmoozePlacebo
Started2021
Completed1818
Not completed23
Withdrew: Withdrawal by subject12
Withdrew: Administrative reason11

Outcome measures

PrimaryInternational 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.

Time frame:
56 days
Reported as:
Mean · units on a scale
International Prostate Symptom Score (IPSS)
units on a scaleUmoozePlacebo
International prostate symptom score9.83 ± 4.4813.6 ± 6.88
Difference in IPSS between V1 and V6-3.39 ± 6.11-5.94 ± 8.11
SecondaryMaximum Flow Rate (Qmax)

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

Time frame:
56 days
Reported as:
Mean · ml/ sec
Maximum Flow Rate (Qmax)
ml/ secUmoozePlacebo
Qmax14.4 ± 4.2912.72 ± 6.57
Difference of Qmax between V1 and V62.88 ± 3.772.49 ± 5.46
SecondaryPostvoid Residual Volume (PVR)

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

Time frame:
56 days
Reported as:
Mean · ml
Postvoid Residual Volume (PVR)
mlUmoozePlacebo
Post- Void Residual Volume (PVR)35.3 ± 35.967.2 ± 47.8
Difference of PVR between V1 and V6-8.39 ± 31.914.8 ± 32.8
Statistical analysis
  • Umooze vs Placebo · t-test, 1 sided · p = <0.05
SecondaryProstate Volume

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

Time frame:
56 days
Reported as:
Mean · cm^3
Prostate Volume
cm^3UmoozePlacebo
Prostate Volume29.1 ± 11.538.2 ± 20.1
Difference of prostate volume between V1 and V6-8.17 ± 12.7-1.33 ± 7.36
Statistical analysis
  • Umooze vs Placebo · t-test, 1 sided · p = <0.05
SecondaryProstate-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.

Time frame:
56 days
Reported as:
Mean · ng/ml
Prostate-specific Antigen (PSA) Level
ng/mlUmoozePlacebo
Prostate- specific Antigen (PSA)1.67 ± 1.342.22 ± 1.69
Difference of PSA between V1 and V60.14 ± 0.320.26 ± 0.76
PrimaryQuality- 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.

Time frame:
56 days
Reported as:
Mean · units on a scale
Quality- Of- Life Index (QoL)
units on a scaleUmoozePlacebo
Quality-of-Life (QoL)2.72 ± 1.073.22 ± 1.17
Difference of QoL between V1 and V6-0.61 ± 1.20-0.56 ± 1.20
PrimaryInternational 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.

Time frame:
56 days
Reported as:
Mean · units on a scale
International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
units on a scaleUmoozePlacebo
International prostate symptom score11.00 ± 4.2414.33 ± 3.21
Difference in IPSS between V1 and V6-9.50 ± 3.54-4.33 ± 1.53
Statistical analysis
  • Umooze vs Placebo · t-test, 1 sided · p = <0.05
PrimaryQuality 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.

Time frame:
56 days
Reported as:
Mean · units on a scale
Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
units on a scaleUmoozePlacebo
Quality of Life (QoL)2.73 ± 1.103.27 ± 1.10
Difference of QoL between V1 and V6-0.82 ± 0.87-0.09 ± 0.70
Statistical analysis
  • Umooze vs Placebo · t-test, 1 sided · p = <0.05

Adverse events

Collected over 56 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Umooze—0/20 (0%)2/20 (10%)
Placebo—0/21 (0%)2/21 (9.5%)
Most frequent other events
Most frequent other events
EventUmoozePlacebo
RushImmune system disorders2/201/21
InsomniaNervous system disorders0/201/21
HypertensionCardiac disorders0/201/21

Baseline characteristics

The baseline analysis includes the International Prostate Symptom Score (IPSS), quality-of-life (QoL), urinary flow rate (Qmax), postvoided residual volume (PVR), prostate volume, serum PSA level. All the subjects have the history of benigh prostate hyperplasia and have been receiving the medication for this condition.

Age, Categorical
Age, Categorical(Participants)UmoozePlaceboTotal
<=18 years000
Between 18 and 65 years11819
>=65 years71017
Sex: Female, Male
Sex: Female, Male(Participants)UmoozePlaceboTotal
Female000
Male181836
Race (NIH/OMB)
Race (NIH/OMB)(Participants)UmoozePlaceboTotal
American Indian or Alaska Native000
Asian181836
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)UmoozePlaceboTotal
Taiwan181836
Internation Prostate Symptom Score (IPSS)
Internation Prostate Symptom Score (IPSS)(units on a scale)UmoozePlaceboTotal
Mean13.22 ± 6.2619.5 ± 8.0316.36 ± 7.67
Quality-of-Life
Quality-of-Life(units on a scale)UmoozePlaceboTotal
Mean3.33 ± 1.503.78 ± 1.223.56 ± 1.34
Uroflowmetry (UFR) measure of maximum flow rate (Qmax)
Uroflowmetry (UFR) measure of maximum flow rate (Qmax)(ml/ sec)UmoozePlaceboTotal
Mean11.5 ± 2.8810.23 ± 3.7110.85 ± 3.29
Postvoid Residual Volume (PVR)
Postvoid Residual Volume (PVR)(ml)UmoozePlaceboTotal
Mean43.7 ± 27.652.4 ± 67.048.06 ± 50.00

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Kaohsiung Municipal TA- TUNG Hospital
    Kaohsiung City, 80145, Taiwan
09

References and documents

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 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02313233
Lead sponsor
Golden Biotechnology Corporation
Responsible party
Sponsor
First posted
Dec 10, 2014
Start date
Dec 2013
Primary completion
May 2015
Completion
May 2015
Results posted
Dec 31, 2015
Last update
Jun 21, 2016

Study contacts

Ching- Chia Li, M.D
principal investigator · Kaohsiung Municipal Ta-Tung Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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