The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: VGH-BPH1
* Drug: Placebo (Corn starch pill manufactured to mimic VGH-BPH1)


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VGH-BPH1 group<br>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<br>* A scientific Chinese granule powder<br>|
| Placebo Comparator: Control group<br>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)<br>* Corn starch pill manufactured to mimic VGH-BPH1<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | 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 | 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) | 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） | 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) | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign Prostatic Hyperplasia, Traditional Chinese medicine