Benign Prostatic Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia, Traditional Chinese medicine
Brief 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.
Interventions
DRUGVGH-BPH1
A scientific Chinese granule powder
DRUGPlacebo (Corn starch pill manufactured to mimic VGH-BPH1)
Corn starch pill manufactured to mimic VGH-BPH1
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
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.
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International prostate symptom score (IPSS) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International index of erectile function (IIEF) | 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） | 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. |
| Constitution in Chinese Medicine Questionnaire (CCMQ) | 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. |
| Voiding time and time to maximum flow | 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) |
| Voided volume (VV) | Change from Baseline VV at eight weeks, ten weeks, eighteen weeks | To calculate the amount of urine (ml) |
| Post-voiding residual urine | 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. |
Countries
Taiwan
Outcome results
None listed