The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03829904
• Other study ID #: 2018-01-019C
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 6, 2019
• Est. completion date: January 2, 2020

Study information

• Verified date: April 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• VGH-BPH1
A scientific Chinese granule powder
• Placebo (Corn starch pill manufactured to mimic VGH-BPH1)
Corn starch pill manufactured to mimic VGH-BPH1

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline IPSS at eight weeks, ten weeks, eighteen weeks
Primary	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.	Change from Baseline AMS at eight weeks, ten weeks, eighteen weeks
Secondary	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.	Change from Baseline CCMQ at eight weeks, ten weeks, eighteen weeks
Secondary	Post-voiding residual urine	To measure and compare the amount of urine left in the bladder after urination before and after treatment.	Change from Baseline post-voiding residual urine at eight weeks, ten weeks, eighteen weeks
Secondary	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.	Change from Baseline IIEF at eight weeks, ten weeks, eighteen weeks
Secondary	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.	Change from Baseline Qmax and Qave at eight weeks, ten weeks, eighteen weeks
Secondary	Voided volume (VV)	To calculate the amount of urine (ml)	Change from Baseline VV at eight weeks, ten weeks, eighteen weeks
Secondary	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)	Change from Baseline Voiding time and time to maximum flow at eight weeks, ten weeks, eighteen weeks