The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

Phase 1

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: VGH-BPH1; Drug: Placebo (Corn starch pill manufactured to mimic VGH-BPH1)

• Registration Number: NCT03829904
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study First Submitted: 2019-01-24
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2019-03-06
• Primary Completion: 2020-01-02
• Study Completion: 2020-01-02
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VGH-BPH1 group	VGH-BPH1	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.
Control group	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.

Primary Outcome Measures

Name	Time	Method
Aging Male Symptoms score (AMS)	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.
International prostate symptom score (IPSS)	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.

Secondary Outcome Measures

Name	Time	Method
Constitution in Chinese Medicine Questionnaire (CCMQ)	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.
International index of erectile function (IIEF)	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.
Post-voiding residual urine	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.
Maximum flow rate (Qmax) and Average flow rate (Qave）	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.
Voided volume (VV)	Change from Baseline VV at eight weeks, ten weeks, eighteen weeks	To calculate the amount of urine (ml)
Voiding time and time to maximum flow	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)

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan