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The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

Primary Purpose

Benign Prostatic Hyperplasia

Status

Completed

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

VGH-BPH1

Placebo (Corn starch pill manufactured to mimic VGH-BPH1)

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, Traditional Chinese medicine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

VGH-BPH1 group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Post-voiding residual urine

To measure and compare the amount of urine left in the bladder after urination before and after treatment.

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.

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.

Voided volume (VV)

To calculate the amount of urine (ml)

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)

Full Information

NCT ID

NCT03829904

First Posted

January 24, 2019

Last Updated

April 9, 2020

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT03829904

Brief Title

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

March 6, 2019 (Actual)

Primary Completion Date

January 2, 2020 (Actual)

Study Completion Date

January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia, Traditional Chinese medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

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

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VGH-BPH1 group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

VGH-BPH1

Intervention Description

A scientific Chinese granule powder

Intervention Type

Drug

Intervention Name(s)

Placebo (Corn starch pill manufactured to mimic VGH-BPH1)

Intervention Description

Corn starch pill manufactured to mimic VGH-BPH1

Primary Outcome Measure Information:

Title

International prostate symptom score (IPSS)

Description

To measure the severity of lower urinary tract symptoms. Each item is scored 0-5, yielding a total between 0-35.

Time Frame

Change from Baseline IPSS at eight weeks, ten weeks, eighteen weeks

Title

Aging Male Symptoms score (AMS)

Description

To evaluate health-related quality of life in aging men. Each item is scored 1-5, yielding a total between 17-85.

Time Frame

Change from Baseline AMS at eight weeks, ten weeks, eighteen weeks

Secondary Outcome Measure Information:

Title

Constitution in Chinese Medicine Questionnaire (CCMQ)

Description

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.

Time Frame

Change from Baseline CCMQ at eight weeks, ten weeks, eighteen weeks

Title

Post-voiding residual urine

Description

To measure and compare the amount of urine left in the bladder after urination before and after treatment.

Time Frame

Change from Baseline post-voiding residual urine at eight weeks, ten weeks, eighteen weeks

Title

International index of erectile function (IIEF)

Description

To evaluate male sexual function over the past 6 months. Each item is scored 1-5, yielding a total between 5-25.

Time Frame

Change from Baseline IIEF at eight weeks, ten weeks, eighteen weeks

Title

Maximum flow rate (Qmax) and Average flow rate (Qave）

Description

To determine peak urine flow rate and average urine flow rate. They are calculated by ml/sec.

Time Frame

Change from Baseline Qmax and Qave at eight weeks, ten weeks, eighteen weeks

Title

Voided volume (VV)

Description

To calculate the amount of urine (ml)

Time Frame

Change from Baseline VV at eight weeks, ten weeks, eighteen weeks

Title

Voiding time and time to maximum flow

Description

To calculate the length of time it takes to empty bladder completely and the peak urine flow time (sec)

Time Frame

Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male patients who have been diagnosed with benign prostatic hyperplasia

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shinn-Jang Hwang, M.D.

Organizational Affiliation

Taipei Veterans General Hospital, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

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The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

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