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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VGH-BPH1 group | Experimental | 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 Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VGH-BPH1 | Drug | A scientific Chinese granule powder |
| |
| Placebo (Corn starch pill manufactured to mimic VGH-BPH1) |
| Measure | Description | Time Frame |
|---|---|---|
| International prostate symptom score (IPSS) | To measure the severity of lower urinary tract symptoms. Each item is scored 0-5, yielding a total between 0-35. | Change from Baseline IPSS at eight weeks, ten weeks, eighteen weeks |
| Aging Male Symptoms score (AMS) | To evaluate health-related quality of life in aging men. Each item is scored 1-5, yielding a total between 17-85. | Change from Baseline AMS at eight weeks, ten weeks, eighteen weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Constitution in Chinese Medicine Questionnaire (CCMQ) | 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. | Change from Baseline CCMQ at eight weeks, ten weeks, eighteen weeks |
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Inclusion Criteria:
Exclusion Criteria:
Male patients who have been diagnosed with benign prostatic hyperplasia
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| Name | Affiliation | Role |
|---|---|---|
| Shinn-Jang Hwang, M.D. | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16385194 | Background | Nickel JC. The overlapping lower urinary tract symptoms of benign prostatic hyperplasia and prostatitis. Curr Opin Urol. 2006 Jan;16(1):5-10. doi: 10.1097/01.mou.0000193365.46081.cd. | |
| 11857671 | Background | Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available. |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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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.
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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.
| Drug |
Corn starch pill manufactured to mimic VGH-BPH1 |
|
| Post-voiding residual urine |
To measure and compare the amount of urine left in the bladder after urination before and after treatment. |
| Change from Baseline post-voiding residual urine at eight weeks, ten weeks, eighteen weeks |
| International index of erectile function (IIEF) | To evaluate male sexual function over the past 6 months. Each item is scored 1-5, yielding a total between 5-25. | Change from Baseline IIEF at eight weeks, ten weeks, eighteen weeks |
| Maximum flow rate (Qmax) and Average flow rate (Qave） | To determine peak urine flow rate and average urine flow rate. They are calculated by ml/sec. | Change from Baseline Qmax and Qave at eight weeks, ten weeks, eighteen weeks |
| Voided volume (VV) | To calculate the amount of urine (ml) | Change from Baseline VV at eight weeks, ten weeks, eighteen weeks |
| Voiding time and time to maximum flow | To calculate the length of time it takes to empty bladder completely and the peak urine flow time (sec) | Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks |
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| D052801 |
| Male Urogenital Diseases |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |