NCT05862597

Brief Summary

COVID-19 has caused various long-term symptoms affecting different bodily functions. A study shows that traditional Chinese medicine can balance the human body disorder after a virus infection and restore health. The study proposes using pulse diagnosis and cardiac rhythm instruments for disease diagnosis and analysis, decomposing time domain pulse wave signals into different frequency ranges and calculating the "spectral energy ratio" and EP to quantify the patient's pathological pulse. The method has been applied to pulse wave analysis of people with suboptimal health status, and its effectiveness has been preliminarily confirmed. The study aims to find the relationship between these parameters and clinical subjective scale scores, to establish an objective data bridge for Chinese and Western medicine diagnosis. In the future, the analysis method will include more subject data to verify the completeness of the method and establish a feasible prediction model.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

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

First Submitted

Initial submission to the registry

March 20, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

March 20, 2023

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • "Skylark" Pulse Analysis System

    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 .

    6 sceond

Secondary Outcomes (1)

  • Post-Acute Covid-19 Syndrome questionnaires

    1 day

Study Arms (2)

Health Status

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

Diagnostic Test: HRV and Pulse diagnosis

Post-Covid syndrome

(A) Age between 20-70 years old, male or female. (B) Have a history of Covid-19 infection. (C) It has been 3 months since the day when the rapid screening test was negative. Antigen positive turn to negative (D) At least one symptom that cannot be explained by other diagnoses and lasts for at least 2 months after being infected with Covid-19.

Diagnostic Test: HRV and Pulse diagnosis

Interventions

Palpation of the 6 pulse positions (right cun, right guan, right chi, left cun, left guan, left chi) measured by the pulse diagnostic instrument.

Health StatusPost-Covid syndrome

Eligibility Criteria

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

Patients who have at least one symptom that cannot be explained by other diagnoses and lasts for at least 2 months after being infected with Covid-19.

You may qualify if:

  • Adults the age between 20-70 years old with a history of Covid-19 infection,have been an interval of 3 months from the day when the rapid screening test was negative and have some unexplained symptom after being infected with Covid-19 and last for at least 2 months.

You may not qualify if:

  • Patient characteristics: have been diagnosed with Covid-19 within seven days, positive in the rapid test,pregnant women or take drugs that could easily affect the heart rate, such as β-Blocker, etc., or installed a pacemaker.
  • Disease characteristics: Subjects who have been diagnosis of mental illness by doctors,or diseases such as cancer that fall under the scope of major diseases covered by the national health insurance .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Traditional Medicine, Taipei Veterans General Hospital

Taipei County, 112, Taiwan

RECRUITING

Study Officials

  • Yen-Ying KUNG, doctor

    Taipei Veterans General Hospital, Taiwan

    STUDY DIRECTOR

Central Study Contacts

Yen-Ying KUNG, doctor

CONTACT

Mei-Chen Lo, researcher

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

March 20, 2023

First Posted

May 17, 2023

Study Start

March 23, 2023

Primary Completion

February 14, 2024

Study Completion

February 14, 2024

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations