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

NCT02313233 | Completed Results

• 1 other identifier: IRC01110908
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Maximum Flow Rate (Qmax)

  56 days

• Postvoid Residual Volume (PVR)

  56 days

• Prostate Volume

  56 days

• Prostate-specific Antigen (PSA) Level

  56 days

Study Arms (2)

Umooze

EXPERIMENTAL

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

Dietary Supplement: Umooze

Placebo

PLACEBO COMPARATOR

Cornstarch.

Dietary Supplement: Placebo

Interventions

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.

Umooze

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Golden Biotechnology Corporation: lead

Study Sites (1)

Kaohsiung Municipal TA- TUNG Hospital

Kaohsiung City, 80145, Taiwan

Location

Related 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.

  PMID: 21073697 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.

  PMID: 17536892 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.

  PMID: 11507733 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.

  PMID: 12678210 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.

  PMID: 10999046 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.

  PMID: 12679907 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.

  PMID: 16571087 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.

  PMID: 10828668 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Ching- Chia Li
• Organization: Kaohsiung Municipal TA- TUNG Hospital

886-7-291-1101

Study Officials

• Ching- Chia Li, M.D

  Kaohsiung Municipal Ta-Tung Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 10, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 21, 2016
• Results First Posted: December 31, 2015

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)