DetectionNCT05862597
Post COVID-19 Syndrome Study With Questionnaires and Instruments Measurements
An observational study of Detection, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Detection
- What is being tested?
- HRV and Pulse diagnosis
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Mar 2023to 14 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Center for Traditional Medicine, Taipei Veterans General Hospital
Taipei County, 112
Yenying kung, doctor, 0228757453 ext. 333, yykung@vghtpe.gov.tw
About this study
Official title: Post COVID-19 syndrome-the Correlation With Suboptimal Health Status and Its Changes of Pulse Diagnosis and Autonomic Nervous System
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.
Read the detailed description
The coronavirus pneumonia (COVID-19) epidemic has a major global impact since 2019. So far, due to the continuous emergence of mutated strains of the virus, in addition to different clinical symptoms, the causes of disease and prognosis of infected patients are also different. With the rapid increase in the number of confirmed cases in Taiwan, we can see that there are many sequelae caused by the COVID-19. Although most of the infected patients can fully recover, some people have various medium and long-term symptoms, which are called "Long COVID or Post COVID". In addition to causing lung tissue damage and inflammation, the COVID-19 also affects the digestive system, causing patients to experience symptoms such as diarrhea, vomiting, and loss of appetite; damages the nervous system, causing insomnia, poor memory, and loss of taste and smell; affects the kidneys function and cause edema, etc.; or even reduce the number of sperm cells in men, thereby affecting reproductive function. It can be seen clinically that some symptoms will last for a long time or appear repeatedly. These symptoms may be present at the time of initial infection, may appear after recovery, or recur over time, affecting the patient's daily life. From our study, it reveals that through the conditioning diagnosis and treatment of traditional Chinese medicine, the human body disorder after virus infection can be balanced as soon as possible and the health can be restored.
This research proposes to use pulse diagnosis instrument and cardiac rhythm instrument for disease diagnosis and analysis, decompose time domain pulse wave signal into time domain signals of different frequency ranges, and extract 0-10Hz low frequency wave, 0-50Hz global wave, 13-50 Hz high-frequency waveform calculates the "spectral energy ratio (SER)" and EP to quantify the patient's pathological pulse. Try to find the relationship between this set of parameters and clinical subjective scale scores. The analysis method proposed in this study has been applied to the pulse wave analysis of people with suboptimal health status (SHS), and its effectiveness has been preliminarily confirmed. Corresponding relationship with heart rate variability (heart rate variability, HRV) high and low frequency parameters, to further link the activation status of sympathetic nerve and parasympathetic nerve, and establish an objective data bridge for Chinese and Western medicine diagnosis. In the future, more subject data will be included to verify the completeness of the analysis method and establish a feasible prediction model.
- Conditions
- Detection
- Being tested
- HRV and Pulse diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV and Pulse diagnosisDiagnostic test
Palpation of the 6 pulse positions (right cun, right guan, right chi, left cun, left guan, left chi) measured by the pulse diagnostic instrument.
| Study group | Role | What they receive |
|---|---|---|
| Health Status | Normal examination in recent six months and not fit inclusion criteria of suboptimal health status. Receives: 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. Receives: Diagnostic Test: HRV and Pulse diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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 .
Measured: 6 sceond
Secondary outcomes (1)
Post-Acute Covid-19 Syndrome questionnaires
suboptimal health status questionnaire-25, SHSQ-25;Body. Constitution Questionaire,BCQ;Post-COVID-19 Chinese Medicine Constitution and Quality of Life Questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start23 Mar 2023
- Primary completion14 Feb 2024 (estimated)
- Study completion14 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University, National Science and Technology Council
- Responsible party
- Sponsor
- Investigators
- Yen-Ying KUNG, doctor, Study director, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862597
- Sponsor's protocol ID
- 2023-01-023AC
- Status last verified
- May 2023
- First submitted
- 20 Mar 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post COVID-19 syndrome-the Correlation With Suboptimal Health Status and Its Changes of Pulse Diagnosis and Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT05862597
- Acronym / sponsor ID
- 2023-01-023AC
- Conditions
- Detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Yang Ming Chiao Tung University, National Science and Technology Council
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 14 Feb 2024 (estimated)
- Study completion
- 14 Feb 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The coronavirus pneumonia (COVID-19) epidemic has a major global impact since 2019. So far, due to the continuous emergence of mutated strains of the virus, in addition to different clinical symptoms, the causes of disease and prognosis of infected patients are also different. With the rapid increase in the number of confirmed cases in Taiwan, we can see that there are many sequelae caused by the COVID-19. Although most of the infected patients can fully recover, some people have various medium and long-term symptoms, which are called "Long COVID or Post COVID". In addition to causing lung tissue damage and inflammation, the COVID-19 also affects the digestive system, causing patients to experience symptoms such as diarrhea, vomiting, and loss of appetite; damages the nervous system, causing insomnia, poor memory, and loss of taste and smell; affects the kidneys function and cause edema, etc.; or even reduce the number of sperm cells in men, thereby affecting reproductive function. It can be seen clinically that some symptoms will last for a long time or appear repeatedly. These symptoms may be present at the time of initial infection, may appear after recovery, or recur over time, affecting the patient's daily life. From our study, it reveals that through the conditioning diagnosis and treatment of traditional Chinese medicine, the human body disorder after virus infection can be balanced as soon as possible and the health can be restored.
This research proposes to use pulse diagnosis instrument and cardiac rhythm instrument for disease diagnosis and analysis, decompose time domain pulse wave signal into time domain signals of different frequency ranges, and extract 0-10Hz low frequency wave, 0-50Hz global wave, 13-50 Hz high-frequency waveform calculates the "spectral energy ratio (SER)" and EP to quantify the patient's pathological pulse. Try to find the relationship between this set of parameters and clinical subjective scale scores. The analysis method proposed in this study has been applied to the pulse wave analysis of people with suboptimal health status (SHS), and its effectiveness has been preliminarily confirmed. Corresponding relationship with heart rate variability (heart rate variability, HRV) high and low frequency parameters, to further link the activation status of sympathetic nerve and parasympathetic nerve, and establish an objective data bridge for Chinese and Western medicine diagnosis. In the future, more subject data will be included to verify the completeness of the analysis method and establish a feasible prediction model.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Status | – | Diagnostic Test: HRV and Pulse diagnosisNormal examination in recent six months and not fit inclusion criteria of suboptimal health status. |
| Post-Covid syndrome | – | Diagnostic Test: HRV and Pulse diagnosis(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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV and Pulse diagnosisPalpation of the 6 pulse positions (right cun, right guan, right chi, left cun, left guan, left chi) measured by the pulse diagnostic instrument. | Diagnostic test | Health Status, Post-Covid syndrome |
Primary outcome
"Skylark" Pulse Analysis System
Time frame: 6 sceond
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 secondary outcome
Post-Acute Covid-19 Syndrome questionnaires
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Ying KUNG, doctor study director
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Detection, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yen-Ying KUNG, doctor (886-2-28757453 ext. 333, yykung@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Skylark" Pulse Analysis System (time frame: 6 sceond). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.