The Effect of Traditional Chinese Medicine on Benign Prostatic Hyperplasia

NCT03829904 | Completed Phase 1 DMC

• 1 other identifier: 2018-01-019C
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; Traditional Chinese medicine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Constitution in Chinese Medicine Questionnaire (CCMQ)

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

• Post-voiding residual urine

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

• International index of erectile function (IIEF)

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

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

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

• Voided volume (VV)

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

Study Arms (2)

VGH-BPH1 group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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)

Interventions

VGH-BPH1 DRUG

A scientific Chinese granule powder

VGH-BPH1 group

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

Corn starch pill manufactured to mimic VGH-BPH1

Control group

Eligibility Criteria

• Gender Eligibility Details: Male patients who have been diagnosed with benign prostatic hyperplasia
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (25)

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MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Starch

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Shinn-Jang Hwang, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 4, 2019
• Study Start: March 6, 2019
• Primary Completion: January 2, 2020
• Study Completion: January 2, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)