The Effect of Traditional Chinese Medicine VGH-BPH1 on Patients With Benign Prostatic Hyperplasia: A Double-blinded Randomized Placebo-controlled Cross-over Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Aging Male Symptoms score (AMS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Placebo is manufactured to have the same appearance with VGH-BPH1, after that VGH-BPH1 and placebo will be coded as package A and B by the manufacturer and the codes will only be revealed after the study ends. Therefore, patients and investigators will not know which package is VGH-BPH1 or placebo.
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
VGH-BPH1 group
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.
干预措施: VGH-BPH1 (Drug)
Control group
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.
干预措施: Placebo (Corn starch pill manufactured to mimic VGH-BPH1) (Drug)
结局指标
主要结局
Aging Male Symptoms score (AMS)
时间窗: 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)
时间窗: 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.
次要结局
- Constitution in Chinese Medicine Questionnaire (CCMQ)(Change from Baseline CCMQ at eight weeks, ten weeks, eighteen weeks)
- International index of erectile function (IIEF)(Change from Baseline IIEF at eight weeks, ten weeks, eighteen weeks)
- Voiding time and time to maximum flow(Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks)
- Post-voiding residual urine(Change from Baseline post-voiding residual urine at eight weeks, ten weeks, eighteen weeks)
- Maximum flow rate (Qmax) and Average flow rate (Qave）(Change from Baseline Qmax and Qave at eight weeks, ten weeks, eighteen weeks)
- Voided volume (VV)(Change from Baseline VV at eight weeks, ten weeks, eighteen weeks)