NCT04516629

Using the Objective Physiological Parameters to Test TCM Syndrome in Sub-health Subjects

Completed Last updated 18 August 2020

What this trial tests

trial testing heart rate variability, pulse diagnosis device in Health Status in 100 participants. Completed in 30 December 2017.

Timeline

21 March 2017

Primary endpoint
30 December 2017

30 December 2017

Quick facts

Lead sponsor	National Yang Ming Chiao Tung University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	21 March 2017
Primary completion	30 December 2017
Estimated completion	30 December 2017
Sites	1 location across Taiwan

Drugs / interventions tested

• heart rate variability, pulse diagnosis device

Conditions studied

• Health Status — all drugs for Health Status →

Sponsor

National Yang Ming Chiao Tung University

Who can join

Adults 20 to 70, any sex, with Health Status. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Suboptimal health status (SHS) is a dynamic state potential clinical stage or prior psychosomatic disease stage during which people have not been diagnosed with a disease, but they have risk factors for illness and have tendency to develop diseases. The term refers to an existing condition of ill health that could lead to a pathologic condition but could also be eliminated, enabling the individual in question to return to a state of good health. Traditional Chinese medicine (TCM) emphasizes the importance of health care and the idea that preventive treatment for diseases is superior to curative treatment. Therefore, early TCM-based intervention can improve the health status of people with SHS. People with SHS often experience such nonspecific symptoms as fatigue; such symptoms are typical of SHS from the perspective of TCM. The present study investigated people with SHS and fatigue as their primary symptom. All enrolled participants completed a physical questionnaire, after which their physiological parameters were monitored using a cloud physiological signal monitoring system to investigate correlations with TCM patterns. Methods: The participants first completed a body constitution questionnaire, the WHO Quality of Life questionnaire, the SHSQ-25 questionnaire, the Epworth Sleepiness Scale, and the Pittsburgh Sleep Quality Index, and subsequently underwent sphygmography to determine their pulse patterns. Analyses of pulse waves were presented in relation to the spectral energy ratio (SER), and SER10 scores represented subtle changes in internal organ blood flow; 13-50-Hz spectrum analysis for pulse delineated any flow energy deviation in organs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.