The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia
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|ClinicalTrials.gov Identifier: NCT03829904|
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : April 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Drug: VGH-BPH1 Drug: Placebo (Corn starch pill manufactured to mimic VGH-BPH1)||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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 (Participant, Investigator)|
|Masking Description:||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.|
|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|
|Actual Study Start Date :||March 6, 2019|
|Actual Primary Completion Date :||January 2, 2020|
|Actual Study Completion Date :||January 2, 2020|
Experimental: 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.
A scientific Chinese granule powder
Placebo Comparator: 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.
Drug: Placebo (Corn starch pill manufactured to mimic VGH-BPH1)
Corn starch pill manufactured to mimic VGH-BPH1
- International prostate symptom score (IPSS) [ Time Frame: 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.
- Aging Male Symptoms score (AMS) [ Time Frame: 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.
- Constitution in Chinese Medicine Questionnaire (CCMQ) [ Time Frame: 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.
- Post-voiding residual urine [ Time Frame: 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.
- International index of erectile function (IIEF) [ Time Frame: 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.
- Maximum flow rate (Qmax) and Average flow rate (Qave） [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829904
|Taipei Veterans General Hospital|
|Taipei, Taiwan, 112|
|Principal Investigator:||Shinn-Jang Hwang, M.D.||Taipei Veterans General Hospital, Taiwan|