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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313233
• Other study ID #: IRC01110908
• Status: Completed
• Phase: N/A
• First received: December 5, 2014
• Last updated: November 27, 2015
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Golden Biotechnology Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Municipal TA- TUNG Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Golden Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	56 days	No
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.	56 days	No
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.	56 days	No
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.	56 days	No
Secondary	Maximum Flow Rate (Qmax)	It's used to determine the degree of urinary difficulty.	56 days	No
Secondary	Postvoid Residual Volume (PVR)	The PVR urine test measures the amount of urine left in the bladder after urination.	56 days	No
Secondary	Prostate Volume	It's related to progression of benign prostatic hyperplasia (BPH).	56 days	No
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.	56 days	No