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The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03829904
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: VGH-BPH1
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Voided volume (VV) [ Time Frame: Change from Baseline VV at eight weeks, ten weeks, eighteen weeks ]
    To calculate the amount of urine (ml)

  6. 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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients who have been diagnosed with benign prostatic hyperplasia
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Shinn-Jang Hwang, M.D. Taipei Veterans General Hospital, Taiwan
More Information
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Publications:

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03829904    
Other Study ID Numbers: 2018-01-019C
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Benign Prostatic Hyperplasia
Traditional Chinese medicine
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases