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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04729335
Other study ID # N201805104
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 10, 2019
Est. completion date December 31, 2020

Study information

Verified date January 2021
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Western medicine, as to disease detection, is based on histological pathology and organ anatomy, therefore biochemistry and medical imageology were developed to determine the location and mechanism of the sickness. Chinese medicine, in the other way around, follow the harmony between man and nature, creating four ways of diagnosis, namely looking, listening, questioning and pulse feeling, which evaluate the physiological homeostasis by the yin-yang of qi and blood, further judging the energy exchange between individual and the universe.


Description:

Western medicine, as to disease detection, is based on histological pathology and organ anatomy, therefore biochemistry and medical imageology were developed to determine the location and mechanism of the sickness. Chinese medicine, in the other way around, follow the harmony between man and nature, creating four ways of diagnosis, namely looking, listening, questioning and pulse feeling, which evaluate the physiological homeostasis by the yin-yang of qi and blood, further judging the energy exchange between individual and the universe. Pulse sound provides perfect detection of disease in Chinese medicine. Hence we plan to digitalize the pulse sound for a better interpretation of the sickness. According to past studies of pulse sound from radial artery, the lower frequency is below 25Hz, which falls into the detection range of Messener's corpuscles (2-80Hz), which are located intensively in index and middle fingers. However, radial artery is relative thinner and the pulse sound is not easy to target by the microphone, not to mention the interference from artery sclerosis. To this end our research group developed Phonocardiac spectrometry (PCS) to replace the traditional pulse instrument. Since heart beats continuously, we hypothesize that each organ is regularly sending the signal back to heart, which modulate the contraction and beating of heart, reflecting different state of each organ. Heart is just like the commander of an orchestra band, who can direct the rhythm and style of the band by the music score and instruments. Once the instrument is damaged, the commander (heart) also adjusts himself. PCS can easily locate the pulse sound, and directly detect and analyze the cardiac spectrum. The real-time state in heart-organ axis can be readily monitored, recorded and investigated by PCS. Our preliminary analysis focuses on patients with liver and pancreatic cancers. The results demonstrate the different pattern of cardiac spectrum between patients and normal people, which can be further sorted by disease types. By applying PCS measurement and the novel algorithm calculation to various diseases, we aim to build up a novel platform for disease screening or even diagnosis.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 31, 2020
Est. primary completion date May 19, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - Volunteer, out- and in-patients in gastroenterology division of Wanfang hospital. Exclusion Criteria: - 1.The decline and fall of informed consent. - 2.Pregnancy. - 3.Heart murmur grading greater or equal to level 3. - 4.Cardiac Arrhythmia. - 5.Patient with critical conditions such as renal or heart failure.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
phonocardiac spectrometry
Detection and application of organic disease with phonocardiac spectrometry

Locations

Country Name City State
Taiwan Wanfang Hospital Taipei Wenshan District

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readout of phonocardiac spectrometry for organ disease Readout of phonocardiac spectrometry for organ disease 6 months