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

NCT ID: NCT04802252

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-06-01

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia; Radial Artery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lili Cao

dean of orthopedic department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucheng Song, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Locations

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lucheng Song, Doctor

Role: CONTACT

lucheng.s@163.com

+8613589089003

Facility Contacts

Lili M Cao, PH.D

Role: primary

qykyc309@163.com

References

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Other Identifiers

SFUYIN-04

Identifier Type: -

Identifier Source: org_study_id