A Diagnostic Study of Abnormal Acoustic Waves in Modern Pulse in Benign Prostatic Hyperplasia

March 14, 2021 updated by: Lili Cao, Qianfoshan Hospital

Pulse diagnosis is one of the traditional diagnostic methods of traditional Chinese medicine, which is of great significance in the process of disease diagnosis.Pulse diagnosis is the diagnosis of disease by touching the pulse of the radial artery at the wrist. Different diseases reflect different pulse characteristics.What we've found in long-term clinical observation is that patients with benign prostatic hyperplasia have something different in their pulse,the abnormal pulse we called "astringent pulse".There is no modern physiologic and pathological description on the occurrence of "astringent pulse" in traditional pulse science, so we study it from acoustics perspective.Our team thinks that every beat of the heart produces a vibration, which produces sound waves，the sound waves travel through the blood and eventually reflect off the arterial walls.When an organ(such as the prostate)，develops hyperplasia, local blood flow changes,the flow of blood, which should be laminar, changes and becomes turbulent，the conduction of sound waves in turbulence is disordered，so we end up with pulse features that are different from normal people that are reflected on the arterial wall.

We have previously studied the pulse characteristics of chronic gastritis, coronary heart disease, cirrhosis and some other diseases，different pulse sounds were collected and analyzed using an independently developed Acoustic Pulse Detection System，the ideal results have been obtained.We found that most of the abnormal sound waves were between 20Hz and 500Hz, so we classified this sound wave as low frequency and audible sound wave.Based on the above analysis, this study will use the acoustic pulse detection system to collect the pulse images of patients with benign prostatic hyperplasia(BPH).We expected to collect the pulse waves of 62 patients and 62 relatively healthy people without BPH, and use Fourier transform, wavelet analysis and other analysis methods to study the characteristics of the collected sound waves, and observe the pulse characteristics of BPH disease.Then diagnostic tests were carried out to calculate the sensitivity and specificity of the acoustic pulse detection system in the diagnosis of BPH.

This experiment will further verify the effectiveness of pulse diagnosis of diseases, and finally lay a foundation for the development of pulse diagnostic instrument can diagnose a variety of diseases.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
        • Contact:
        • Principal Investigator:
          • Lucheng Song, PH.D
        • Principal Investigator:
          • Tao Ma
        • Sub-Investigator:
          • Jin Wang, PH.D
        • Sub-Investigator:
          • Wenjun Yu
        • Sub-Investigator:
          • Yameng Zhang, PH.D
        • Sub-Investigator:
          • Shanmei Sun, PH.D
        • Sub-Investigator:
          • Qian Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Middle-aged and older men with benign prostatic hyperplasia & middle-aged and older men without benign prostatic hyperplasia

Description

Inclusion Criteria:

Test group:

  1. From March 2020 to June 2021, patients of Chinese Medicine outpatient department, ward and physical examination were continuously recruited in the First Affiliated Hospital of Shandong First Medical University;
  2. Research site: The First Affiliated Hospital of Shandong First Medical University;
  3. Comprehensive evaluation of symptoms, signs and ultrasound examination, meeting the diagnostic criteria of BPH in middle-aged and elderly male patients;
  4. Ages ranged from 50 to 80 years, and vital signs were stable;
  5. Patients with informed consent to accept this pulse collection;

Control group:

  1. From March 2020 to June 2021, patients of Chinese Medicine outpatient department, ward and physical examination were continuously recruited in the First Affiliated Hospital of Shandong First Medical University ;
  2. Research site: The First Affiliated Hospital of Shandong First Medical University;
  3. Symptoms, signs and ultrasonography were evaluated comprehensively, and middle-aged and elderly men with BPH disease were clearly excluded;
  4. Ages ranged from 50 to 80 years, and vital signs were stable;
  5. Patients with informed consent to accept this pulse collection;

Exclusion Criteria:

Test group:

  1. Those who have a serious illness and sit for less than 10 minutes in a quiet state;
  2. Symptoms, signs and ultrasonography were evaluated comprehensively, and middle-aged and elderly men with BPH disease were clearly excluded;
  3. Patients with severe infectious diseases;
  4. Fanguan pulse, oblique flying pulse, etc. who are not easy to collect pulse;
  5. Those who have incomplete information due to subjective or objective reasons that affect the result judgment;
  6. Patients with Parkinson's or other limb tremors;
  7. Those who has not signed an informed consent form;
  8. Patients with atrial fibrillation.

Control group:

  1. Those who have a serious illness and sit for less than 10 minutes in a quiet state;
  2. Comprehensive evaluation of symptoms, signs and ultrasound examination, meeting the diagnostic criteria of BPH in middle-aged and elderly male patients；
  3. Patients with severe infectious diseases;
  4. Fanguan pulse, oblique flying pulse, etc. who are not easy to collect pulse;
  5. Those who have incomplete information due to subjective or objective reasons that affect the result judgment;
  6. Patients with Parkinson's or other limb tremors;
  7. Those who has not signed an informed consent form;
  8. Patients with atrial fibrillation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
62 patients with benign prostatic hyperplasia in the experimental group
The pulse sound waves of three parts and five layers of each of the two hands of 62 patients with benign prostatic hyperplasia were collected by acoustic pulse detection system.
62 relatively healthy men without benign prostatic hyperplasia in the control group
The pulse sound waves of three parts and five layers of each of the two hands of 62 relatively healthy men without benign prostatic hyperplasia were collected by acoustic pulse detection system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The characteristic sound waves extracted from radial artery of patients with benign prostatic hyperplasia and relatively healthy men without benign prostatic hyperplasia are distinguished.
Time Frame: 30 minutes
This characteristic sound wave can distinguish patients with benign prostatic hyperplasia from relatively healthy men without benign prostatic hyperplasia.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Investigators

  • Principal Investigator: Lucheng Song, Doctor, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

March 14, 2021

First Submitted That Met QC Criteria

March 14, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 14, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFUYIN-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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