NCT03829904

The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	VGH-BPH1	A scientific Chinese granule powder
DRUG	Placebo (Corn starch pill manufactured to mimic VGH-BPH1)	Corn starch pill manufactured to mimic VGH-BPH1

Timeline

• Start date: 2019-03-06
• Primary completion: 2020-01-02
• Completion: 2020-01-02
• First posted: 2019-02-04
• Last updated: 2020-04-13

Locations

1 site across 1 country: Taiwan