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NCT Number: NCT03829904

The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VGH-BPH1

Drug

A scientific Chinese granule powder

Placebo (Corn starch pill manufactured to mimic VGH-BPH1)

Drug

Corn starch pill manufactured to mimic VGH-BPH1

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Voided volume (VV)

    Time frame: Change from Baseline VV at eight weeks, ten weeks, eighteen weeks

    To calculate the amount of urine (ml)

  6. 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)

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2019
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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