NCT02313233

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Golden Biotechnology Corporation · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	Placebo	Placebo is consisted of cornstarch and is provided by by Golden Biotechnology Corp.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-12-10
• Last updated: 2016-06-21
• Results posted: 2015-12-31

Locations

1 site across 1 country: Taiwan