NCT05522413

Brief Summary

Traditional Chinese medicine has a long history of disease diagnosis applications by pulse diagnosis. The pulse "position", "number", "shape", and "momentum" can be used as four guidelines for pulse classification. However, the finger feeling is difficult to be expressed in a quantitative approach for clinical teaching and illness-state recognition. The pressure sensor was applied to measure wrist pulse waveforms for analysis. In this research project, the "discrete wavelet transformation (DWT)" is used to decompose the time-domain pulse into several sets of signals, which are allocated at different frequency bands. The high-frequency signal over the range of 12-50 Hz is then acquired to calculate the spectral energy ratio (SER) for quantization of the pulse momentum to the persons under the suboptimal health status (SHS).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

August 28, 2022

Last Update Submit

August 29, 2022

Conditions

Keywords

discrete wavelet transformation, Pulse diagnosis in TCM

Outcome Measures

Primary Outcomes (1)

  • Pulse diagnosis data analysis

    Palpation of the 6 pulse positions (right cun, right guan, right chi, left cun, left guan, left chi) measured by the pulse diagnostic instrument are read into the processing program, and then the time domain signal of each pulse position is analyzed in sequence .

    1 day

Secondary Outcomes (1)

  • Suboptimal health status questionnaires

    1 day

Study Arms (2)

Health Status

normal examination in recent six months and not fit inclusion criteria of suboptimal health status.

Suboptimal health Status

(A) Sub-Health Questionnaire (SHSQ-25) ≧35 points (B) Resting blood pressure 120-139/80-89 mmHg measured more than 3 times a week (C) The PSQI score of the sleep questionnaire on the first test is greater than 5 points (D) Body mass index (BMI): 24\~29 Kg/m2

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants have no chronic disease or those who have been diagnosed as Sub-optimal health status by a doctor.

You may qualify if:

  • A+B+C or A+B+D that meet the following description, and those who have no clear diagnosis of chronic diseases by western medicine, can be included:
  • (A) Sub-Health Questionnaire (SHSQ-25) ≧35 points (B) Resting blood pressure 120-139/80-89 mmHg measured more than 3 times a week (C) The PSQI score of the sleep questionnaire on the first test is greater than 5 points (D) Body mass index (BMI): 24\~29 Kg/m2

You may not qualify if:

  • Those with a clear diagnosis of chronic diseases in Western medicine, such as hypertension, diabetes, chronic hepatitis, chronic kidney disease, chronic hyperlipidemia, coronary heart disease, etc., which fall within the scope of chronic diseases under the National Health Insurance
  • Have a definite diagnosis of mental illness by Western medicine
  • Cancer patients
  • Pregnancy
  • Those with obvious inflammatory infection at the time of receipt of the case

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Study Officials

  • Yen-Ying KUNG, doctor

    Taipei Veterans General Hospital, Taiwan

    STUDY DIRECTOR

Central Study Contacts

Yen-Ying KUNG, doctor

CONTACT

Chao-Hsiung Tseng, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2022

First Posted

August 31, 2022

Study Start

August 10, 2022

Primary Completion

July 10, 2023

Study Completion

July 10, 2023

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations