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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
A scientific Chinese granule powder
Corn starch pill manufactured to mimic VGH-BPH1
Taipei Veterans General Hospital
Taipei, Taiwan
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.
Time frame: 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.
Time frame: Change from Baseline AMS at eight weeks, ten weeks, eighteen weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline Qmax and Qave at eight weeks, ten weeks, eighteen weeks
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Voided volume (VV)
To calculate the amount of urine (ml)
Time frame: 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)
Time frame: Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks