The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

Taipei Veterans General Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: VGH-BPH1; Drug: Placebo (Corn starch pill manufactured to mimic VGH-BPH1)

Study type: Interventional

Funder types: Other

Identifiers

NCT03829904

2018-01-019C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups, including a placebo group

VGH-BPH1 group

Experimental group

Description:

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.

Treatment:

Drug: VGH-BPH1

Control group

Placebo Comparator group

Description:

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.

Treatment:

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