Benign Prostatic HyperplasiaPhase 1/2NCT03829904

The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

A Phase 1/2 study testing VGH-BPH1 in people with Benign Prostatic Hyperplasia, run by Taipei Veterans General Hospital, Taiwan 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

Search all trials

Trial summary

This randomized, double-blinded, placebo-controlled, crossover clinical trial aims to investigate the effect of VGH-BPH1, a scientific Chinese medicine powder prescription, on patients with benign prostatic hyperplasia. Read more about this study

Who is it for?: Any age, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: VGH-BPH1
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteTaiwan
Study dates: 6 Mar 2019to 2 Jan 2020
Phase: Phase 1/2
Are there results?: None posted in the registry

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 Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients who have been diagnosed with benign prostatic hyperplasia by a urologist
Have been treated with conventional first-line western medicine for more than three months
Patients with moderate to severe benign prostatic hyperplasia (IPSS score >12 points)
Participate voluntarily in the study

Who cannot join

At the same time, use other Chinese herbal medicines or alternative medicine (including drugs and acupuncture) for more than one month.
Syphilis, gonorrhea and other sexually transmitted diseases or urinary tract infections
Urinary tract stones, prostate cancer, bladder cancer or acute and chronic renal failure
Congenital abnormalities such as bladder neck fibrosis, interstitial cystitis or urethral stricture
A history of genital trauma or surgery affecting the muscle or nervous system
Patients with upper urinary tract obstruction, renal edema, etc. affecting renal function
Unable to sign a consent form or unable to communicate with researchers

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei Veterans General Hospital
Taipei, 112

Other trials in Taiwan

About this study

Official title: The Effect of Traditional Chinese Medicine VGH-BPH1 on Patients With Benign Prostatic Hyperplasia: A Double-blinded Randomized Placebo-controlled Cross-over Study

Read the detailed description

Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland due to progressive hyperplasia of the stromal and glandular cells.

The aim of this study is to evaluate the efficacy of traditional Chinese medicine (VGH-BPH1) in treating patients with BPH, by using the experimental BPH-1 powder, including Ji Sheng Shen Qi Wan and Sangpiaoxiao powder as the main prescription, and adding Wuyao, Yizhiren, Danshen, Yinyanghuo, Fupenzi, Huangbo and Zhimu as auxiliary ingredients, to form a 5gm per pack. This study is designed as a double-blinded randomized placebo-controlled cross-over trial to provide experimental evidence and feasibility of traditional Chinese medicine VGH-BPH1 in the treatment of BPH, and to analyze the syndrome pattern of Chinese medicinal prescriptions for subgroups of BPH.

Conditions: Benign Prostatic Hyperplasia
Being tested: VGH-BPH1, Placebo (Corn starch pill manufactured to mimic VGH-BPH1)
Keywords: Benign Prostatic Hyperplasia, Traditional Chinese medicine
Medical subject headings: Prostatic Hyperplasia

What participants receive

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

VGH-BPH1Drug
A scientific Chinese granule powder
Placebo (Corn starch pill manufactured to mimic VGH-BPH1)Drug
Corn starch pill manufactured to mimic VGH-BPH1

Study groups in NCT03829904
Study group	Role	What they receive
VGH-BPH1 group	Experimental	VGH-BPH1 includes Ji Sheng Shen Qi Wan 2.5g, Sangpiaoxiao powder 1.0g, Wuyao 0.3g, Yizhiren 0.3g, Danshen 0.3g, Yinyanghuo 0.3g, Fupenzi 0.1g, Huangbo 0.25g and Zhimu 0.25g, three times per day, each serving a small packet of 5.3 grams of concentrated granules. Receives: Drug: VGH-BPH1
Control group	Placebo comparator	Placebo includes corn starch plus caramel coloring, and added 1/100 VGH-BHP1 compound, three times per day, each serving a small packet of 5.3 grams of concentrated granules. Receives: Drug: Placebo (Corn starch pill manufactured to mimic VGH-BPH1)

What is being measured

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

International prostate symptom score (IPSS)
To measure the severity of lower urinary tract symptoms. Each item is scored 0-5, yielding a total between 0-35.
Measured: Change from Baseline IPSS at eight weeks, ten weeks, eighteen weeks
Aging Male Symptoms score (AMS)
To evaluate health-related quality of life in aging men. Each item is scored 1-5, yielding a total between 17-85.
Measured: Change from Baseline AMS at eight weeks, ten weeks, eighteen weeks

Secondary outcomes (6)

Constitution in Chinese Medicine Questionnaire (CCMQ)
It has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness-heat, blood-stasis, Qi-depression, and special diathesis.
Measured: Change from Baseline CCMQ at eight weeks, ten weeks, eighteen weeks
Post-voiding residual urine
To measure and compare the amount of urine left in the bladder after urination before and after treatment.
Measured: Change from Baseline post-voiding residual urine at eight weeks, ten weeks, eighteen weeks
International index of erectile function (IIEF)
To evaluate male sexual function over the past 6 months. Each item is scored 1-5, yielding a total between 5-25.
Measured: Change from Baseline IIEF at eight weeks, ten weeks, eighteen weeks
Maximum flow rate (Qmax) and Average flow rate (Qave）
To determine peak urine flow rate and average urine flow rate. They are calculated by ml/sec.
Measured: Change from Baseline Qmax and Qave at eight weeks, ten weeks, eighteen weeks
Voided volume (VV)
To calculate the amount of urine (ml)
Measured: Change from Baseline VV at eight weeks, ten weeks, eighteen weeks
Voiding time and time to maximum flow
To calculate the length of time it takes to empty bladder completely and the peak urine flow time (sec)
Measured: Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks

Timeline

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

6 Mar 20192 Jan 2020

First posted4 Feb 2019
Study start6 Mar 2019
Primary completion2 Jan 2020
Study completion2 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 40 participants will be recruited from Division of Urology in a Medical Center. They will be randomizedly allocated into treatment and control groups, each including 20 participants. After eight weeks of taking, there is a two weeks of drug wash-out period. And then two groups will be switched for another eight weeks. The study duration is totally 18 weeks.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03829904
Sponsor's protocol ID: 2018-01-019C
Status last verified: Apr 2020
First submitted: 24 Jan 2019
Last updated: 13 Apr 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Nickel JC. The overlapping lower urinary tract symptoms of benign prostatic hyperplasia and prostatitis. Curr Opin Urol. 2006 Jan;16(1):5-10. doi: 10.1097/01.mou.0000193365.46081.cd.
PubMed 16385194
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671
Barqawi AB, Myers JB, O'Donnell C, Crawford ED. The effect of alpha-blocker and 5alpha-reductase inhibitor intake on sexual health in men with lower urinary tract symptoms. BJU Int. 2007 Oct;100(4):853-7. doi: 10.1111/j.1464-410X.2007.07092.x. Epub 2007 Jul 23.
PubMed 17662074
Miner M, Rosenberg MT, Perelman MA. Treatment of lower urinary tract symptoms in benign prostatic hyperplasia and its impact on sexual function. Clin Ther. 2006 Jan;28(1):13-25. doi: 10.1016/j.clinthera.2006.01.004.
PubMed 16490576
Jung JH, Jae SU, Kam SC, Hyun JS. Correlation between Lower Urinary Tract Symptoms (LUTS) and sexual function in benign prostatic hyperplasia: impact of treatment of LUTS on sexual function. J Sex Med. 2009 Aug;6(8):2299-304. doi: 10.1111/j.1743-6109.2009.01324.x. Epub 2009 Jun 2.
PubMed 19493292
Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. 2012 Jul 19;367(3):248-57. doi: 10.1056/NEJMcp1106637. No abstract available.
PubMed 22808960
Pasko P, Rodacki T, Domagala-Rodacka R, Owczarek D. Interactions between medications employed in treating benign prostatic hyperplasia and food - A short review. Biomed Pharmacother. 2016 Oct;83:1141-1145. doi: 10.1016/j.biopha.2016.08.021. Epub 2016 Aug 20.
PubMed 27551761
Tacklind J, Fink HA, Macdonald R, Rutks I, Wilt TJ. Finasteride for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD006015. doi: 10.1002/14651858.CD006015.pub3.
PubMed 20927745
Corona G, Tirabassi G, Santi D, Maseroli E, Gacci M, Dicuio M, Sforza A, Mannucci E, Maggi M. Sexual dysfunction in subjects treated with inhibitors of 5alpha-reductase for benign prostatic hyperplasia: a comprehensive review and meta-analysis. Andrology. 2017 Jul;5(4):671-678. doi: 10.1111/andr.12353. Epub 2017 Apr 28.
PubMed 28453908
Li MK, Garcia L, Patron N, Moh LC, Sundram M, Leungwattanakij S, Pripatnanont C, Cheng C, Chi-Wai M, Loi-Cheong N. An Asian multinational prospective observational registry of patients with benign prostatic hyperplasia, with a focus on comorbidities, lower urinary tract symptoms and sexual function. BJU Int. 2008 Jan;101(2):197-202. doi: 10.1111/j.1464-410X.2007.07320.x. Epub 2007 Nov 13.
PubMed 18005205
Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA. 1998 Nov 11;280(18):1604-9. doi: 10.1001/jama.280.18.1604.
PubMed 9820264
Pagano E, Laudato M, Griffo M, Capasso R. Phytotherapy of benign prostatic hyperplasia. A minireview. Phytother Res. 2014 Jul;28(7):949-55. doi: 10.1002/ptr.5084.
PubMed 25165780
Keehn A, Lowe FC. Complementary and alternative medications for benign prostatic hyperplasia. Can J Urol. 2015 Oct;22 Suppl 1:18-23.
PubMed 26497340
Ho CC, Singam P, Hong GE, Zainuddin ZM. Male sexual dysfunction in Asia. Asian J Androl. 2011 Jul;13(4):537-42. doi: 10.1038/aja.2010.135. Epub 2011 Jun 6.
PubMed 21643001
Yagi H, Sato R, Nishio K, Arai G, Soh S, Okada H. Clinical efficacy and tolerability of two Japanese traditional herbal medicines, Hachimi-jio-gan and Gosha-jinki-gan, for lower urinary tract symptoms with cold sensitivity. J Tradit Complement Med. 2015 Apr 18;5(4):258-61. doi: 10.1016/j.jtcme.2015.03.010. eCollection 2015 Oct.
PubMed 26587398

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

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Traditional Chinese Medicine VGH-BPH1 on Patients With Benign Prostatic Hyperplasia: A Double-blinded Randomized Placebo-controlled Cross-over Study
ClinicalTrials.gov ID: NCT03829904
Acronym / sponsor ID: 2018-01-019C
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia, Traditional Chinese medicine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Taipei Veterans General Hospital, TaiwanOther government
Study start: 6 Mar 2019 (actual)
Primary completion: 2 Jan 2020 (actual)
Study completion: 2 Jan 2020 (actual)
First posted: 4 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland due to progressive hyperplasia of the stromal and glandular cells.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: 40 participants will be recruited from Division of Urology in a Medical Center. They will be randomizedly allocated into treatment and control groups, each including 20 participants. After eight weeks of taking, there is a two weeks of drug wash-out period. And then two groups will be switched for another eight weeks. The study duration is totally 18 weeks.

Arm	Type	Receives
VGH-BPH1 group	Experimental	Drug: VGH-BPH1VGH-BPH1 includes Ji Sheng Shen Qi Wan 2.5g, Sangpiaoxiao powder 1.0g, Wuyao 0.3g, Yizhiren 0.3g, Danshen 0.3g, Yinyanghuo 0.3g, Fupenzi 0.1g, Huangbo 0.25g and Zhimu 0.25g, three times per day, each serving a small packet of 5.3 grams of concentrated granules.
Control group	Placebo comparator	Drug: Placebo (Corn starch pill manufactured to mimic VGH-BPH1)Placebo includes corn starch plus caramel coloring, and added 1/100 VGH-BHP1 compound, three times per day, each serving a small packet of 5.3 grams of concentrated granules.

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Patients who have been diagnosed with benign prostatic hyperplasia by a urologist
Have been treated with conventional first-line western medicine for more than three months
Patients with moderate to severe benign prostatic hyperplasia (IPSS score >12 points)
Participate voluntarily in the study

Key exclusion criteria (7 listed)

At the same time, use other Chinese herbal medicines or alternative medicine (including drugs and acupuncture) for more than one month.
Syphilis, gonorrhea and other sexually transmitted diseases or urinary tract infections
Urinary tract stones, prostate cancer, bladder cancer or acute and chronic renal failure
Congenital abnormalities such as bladder neck fibrosis, interstitial cystitis or urethral stricture
A history of genital trauma or surgery affecting the muscle or nervous system

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
VGH-BPH1A scientific Chinese granule powder	Drug	VGH-BPH1 group
Placebo (Corn starch pill manufactured to mimic VGH-BPH1)Corn starch pill manufactured to mimic VGH-BPH1	Drug	Control group

Primary outcome

International prostate symptom score (IPSS)
Time frame: Change from Baseline IPSS at eight weeks, ten weeks, eighteen weeks
To measure the severity of lower urinary tract symptoms. Each item is scored 0-5, yielding a total between 0-35.
Aging Male Symptoms score (AMS)
Time frame: Change from Baseline AMS at eight weeks, ten weeks, eighteen weeks
To evaluate health-related quality of life in aging men. Each item is scored 1-5, yielding a total between 17-85.

6 secondary outcomes

Constitution in Chinese Medicine Questionnaire (CCMQ)
Time frame: Change from Baseline CCMQ at eight weeks, ten weeks, eighteen weeks
Post-voiding residual urine
Time frame: Change from Baseline post-voiding residual urine at eight weeks, ten weeks, eighteen weeks
International index of erectile function (IIEF)
Time frame: Change from Baseline IIEF at eight weeks, ten weeks, eighteen weeks
Maximum flow rate (Qmax) and Average flow rate (Qave）
Time frame: Change from Baseline Qmax and Qave at eight weeks, ten weeks, eighteen weeks
Voided volume (VV)
Time frame: Change from Baseline VV at eight weeks, ten weeks, eighteen weeks
Voiding time and time to maximum flow
Time frame: Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
Background: PubMed 16385194Nickel JC. The overlapping lower urinary tract symptoms of benign prostatic hyperplasia and prostatitis. Curr Opin Urol. 2006 Jan;16(1):5-10. doi: 10.1097/01.mou.0000193365.46081.cd.
Background: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
Background: PubMed 17662074Barqawi AB, Myers JB, O'Donnell C, Crawford ED. The effect of alpha-blocker and 5alpha-reductase inhibitor intake on sexual health in men with lower urinary tract symptoms. BJU Int. 2007 Oct;100(4):853-7. doi: 10.1111/j.1464-410X.2007.07092.x. Epub 2007 Jul 23.
Background: PubMed 16490576Miner M, Rosenberg MT, Perelman MA. Treatment of lower urinary tract symptoms in benign prostatic hyperplasia and its impact on sexual function. Clin Ther. 2006 Jan;28(1):13-25. doi: 10.1016/j.clinthera.2006.01.004.
Background: PubMed 19493292Jung JH, Jae SU, Kam SC, Hyun JS. Correlation between Lower Urinary Tract Symptoms (LUTS) and sexual function in benign prostatic hyperplasia: impact of treatment of LUTS on sexual function. J Sex Med. 2009 Aug;6(8):2299-304. doi: 10.1111/j.1743-6109.2009.01324.x. Epub 2009 Jun 2.
Background: PubMed 22808960Sarma AV, Wei JT. Clinical practice. Benign prostatic hyperplasia and lower urinary tract symptoms. N Engl J Med. 2012 Jul 19;367(3):248-57. doi: 10.1056/NEJMcp1106637. No abstract available.
Background: PubMed 27551761Pasko P, Rodacki T, Domagala-Rodacka R, Owczarek D. Interactions between medications employed in treating benign prostatic hyperplasia and food - A short review. Biomed Pharmacother. 2016 Oct;83:1141-1145. doi: 10.1016/j.biopha.2016.08.021. Epub 2016 Aug 20.
Background: PubMed 20927745Tacklind J, Fink HA, Macdonald R, Rutks I, Wilt TJ. Finasteride for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD006015. doi: 10.1002/14651858.CD006015.pub3.
Background: PubMed 28453908Corona G, Tirabassi G, Santi D, Maseroli E, Gacci M, Dicuio M, Sforza A, Mannucci E, Maggi M. Sexual dysfunction in subjects treated with inhibitors of 5alpha-reductase for benign prostatic hyperplasia: a comprehensive review and meta-analysis. Andrology. 2017 Jul;5(4):671-678. doi: 10.1111/andr.12353. Epub 2017 Apr 28.
Background: PubMed 18005205Li MK, Garcia L, Patron N, Moh LC, Sundram M, Leungwattanakij S, Pripatnanont C, Cheng C, Chi-Wai M, Loi-Cheong N. An Asian multinational prospective observational registry of patients with benign prostatic hyperplasia, with a focus on comorbidities, lower urinary tract symptoms and sexual function. BJU Int. 2008 Jan;101(2):197-202. doi: 10.1111/j.1464-410X.2007.07320.x. Epub 2007 Nov 13.
Background: PubMed 9820264Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA. 1998 Nov 11;280(18):1604-9. doi: 10.1001/jama.280.18.1604.
Background: PubMed 25165780Pagano E, Laudato M, Griffo M, Capasso R. Phytotherapy of benign prostatic hyperplasia. A minireview. Phytother Res. 2014 Jul;28(7):949-55. doi: 10.1002/ptr.5084.
Individual participant dataSharing planned: No

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

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.

Shinn-Jang Hwang, M.D. principal investigator

Taipei Veterans General Hospital, Taiwan

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VGH-BPH1 in people with Benign Prostatic Hyperplasia, run by Taipei Veterans General Hospital, Taiwan 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 4 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 13 Apr 2020. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: Change from Baseline IPSS at eight weeks, ten weeks, eighteen weeks). The study lists 2 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 NCT03829904, which also lists 25 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 13 Apr 2020.