Clinical trial NCT03829904: The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
Traditional Chinese medicine
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-02-04
Enrollment: 23
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: International prostate symptom score (IPSS)
timeFrame: Change from Baseline IPSS at eight weeks, ten weeks, eighteen weeks
measure: Aging Male Symptoms score (AMS)
timeFrame: Change from Baseline AMS at eight weeks, ten weeks, eighteen weeks
Secondary outcomes:
measure: Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: Change from Baseline CCMQ at eight weeks, ten weeks, eighteen weeks
measure: Post-voiding residual urine
timeFrame: Change from Baseline post-voiding residual urine at eight weeks, ten weeks, eighteen weeks
measure: International index of erectile function (IIEF)
timeFrame: Change from Baseline IIEF at eight weeks, ten weeks, eighteen weeks
measure: Maximum flow rate (Qmax) and Average flow rate (Qave）
timeFrame: Change from Baseline Qmax and Qave at eight weeks, ten weeks, eighteen weeks
measure: Voided volume (VV)
timeFrame: Change from Baseline VV at eight weeks, ten weeks, eighteen weeks
measure: Voiding time and time to maximum flow
timeFrame: Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Shinn-Jang Hwang, M.D.
role: PRINCIPAL_INVESTIGATOR
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