The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

April 9, 2020 updated by: Taipei Veterans General Hospital, Taiwan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VGH-BPH1 group
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.
Drug: VGH-BPH1
A scientific Chinese granule powder
Placebo Comparator: Control group
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.
Drug: Placebo (Corn starch pill manufactured to mimic VGH-BPH1)
Corn starch pill manufactured to mimic VGH-BPH1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline IPSS at eight weeks, ten weeks, eighteen weeks
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.
Change from Baseline AMS at eight weeks, ten weeks, eighteen weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constitution in Chinese Medicine Questionnaire (CCMQ)
Time Frame: Change from Baseline CCMQ at eight weeks, ten weeks, eighteen weeks
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.
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
To measure and compare the amount of urine left in the bladder after urination before and after treatment.
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
To evaluate male sexual function over the past 6 months. Each item is scored 1-5, yielding a total between 5-25.
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
To determine peak urine flow rate and average urine flow rate. They are calculated by ml/sec.
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
To calculate the amount of urine (ml)
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
To calculate the length of time it takes to empty bladder completely and the peak urine flow time (sec)
Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Shinn-Jang Hwang, M.D., Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2019

Primary Completion (Actual)

January 2, 2020

Study Completion (Actual)

January 2, 2020

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-01-019C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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