The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia
NCT ID: NCT03829904
Last Updated: 2020-04-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
23 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-03-06
Study Completion Date
2020-01-02
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Benign Prostatic Hyperplasia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
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 Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
VGH-BPH1
Intervention Type
DRUG
A scientific Chinese granule powder
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.
Group Type
PLACEBO_COMPARATOR
Placebo (Corn starch pill manufactured to mimic VGH-BPH1)
Intervention Type
DRUG
Corn starch pill manufactured to mimic VGH-BPH1
Interventions
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VGH-BPH1
A scientific Chinese granule powder
Intervention Type
DRUG
Placebo (Corn starch pill manufactured to mimic VGH-BPH1)
Corn starch pill manufactured to mimic VGH-BPH1
Intervention Type
DRUG
Eligibility Criteria
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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
* 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
* 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
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Shinn-Jang Hwang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Locations
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Taipei Veterans General Hospital
Taipei, , Taiwan
Site Status
Countries
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Taiwan
References
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Other Identifiers
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2018-01-019C
Identifier Type: -
Identifier Source: org_study_id
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