HypertensionNCT04434924
The Construction of Precision Medicine in Chinese Medicine
An observational study of Hypertension, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
"Precise medicine" is also called "personal medicine". With the development of big data database, genetic testing and artificial intelligence, the concept of precision medicine has been applied to the diagnosis, treatment and prevention of different diseases. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jun 2020to 31 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were diagnosed as having primary hypertension by cardiologists.
Who may be able to join
- Primary hypertension
- Older than 20 year-old
Who cannot join
- Past history of cancer
- Hemodialysis
- Hypertension caused by renal diseases or endocrine disorders
- Pregnancy
- Patients can not received investigation of body constitution, TCM tongue examination and pulse examination
Trial locations and contacts
1 site in 1 country.
About this study
"Precise medicine" is also called "personal medicine". With the development of big data database, genetic testing and artificial intelligence, the concept of precision medicine has been applied to the diagnosis, treatment and prevention of different diseases. Traditional Chinese medicine (TCM) has traditionally emphasis on personalized medicine, according to each person's body constitution, through discriminatory treatment and personalized treatment methods. Chinese medicine doctors collect patients' information to distinguish the type of TCM pattern, and then according to the different types of diagnosis of traditional Chinese medicine to decide of using herbs, acupuncture, massage and other treatment strategies. However, lacking of objective data of traditional Chinese medicine, the current research on precision medicine in Chinese medicine is still limited. The aim of this study is to establish a big database of traditional Chinese precision medicine, and use the patients with hypertension as the population to conduct research on precision medicine in Chinese medicine.This study will combine the TCM body constitutional questionnaire, tongue diagnosis, pulse diagnosis, Chinese medicine immunoassay and genetic testing. In addition, the information providing by the medical electronic medical record system of China Medical University Hospital will be connected, which include modern medical diagnosis, treatment, blood and biochemical analysis and imaging. We will combine the big data analysis and artificial intelligence interpretation technology to explore the correlation between different TCM syndrome types and gene variations in patients with hypertension and establish a database of TCM precision medicine. We will also conduct the education training and symposium to train TCM precision medical talents and promote public understanding of TCM precision medicine. This project will establish a database of traditional Chinese medicine precision medicine to provide the correlation between different TCM pattern types of patients with hypertension, the reaction to different herbal medicine, and gene mutation, and provide reference for TCM clinicians.
- Conditions
- Hypertension
- Keywords
- Traditional Chinese precision medicine, Chinese medicine immunoassay, Body constitution, genetic variation
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between TCM body constitution and genetic variation
The correlation between TCM body constitution and genetic variation of patients with primary hypertension will be investigated.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start24 Jun 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434924
- Sponsor's protocol ID
- CMUH109-REC1-025
- Status last verified
- Jul 2022
- First submitted
- 15 Jun 2020
- Last updated
- 20 Jul 2022
- 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Construction of Precision Medicine in Chinese Medicine
- ClinicalTrials.gov ID
- NCT04434924
- Acronym / sponsor ID
- CMUH109-REC1-025
- Conditions
- Hypertension
- Keywords
- Traditional Chinese precision medicine, Chinese medicine immunoassay, Body constitution, genetic variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 17 Jun 2020 (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.
"Precise medicine" is also called "personal medicine". With the development of big data database, genetic testing and artificial intelligence, the concept of precision medicine has been applied to the diagnosis, treatment and prevention of different diseases. Traditional Chinese medicine (TCM) has traditionally emphasis on personalized medicine, according to each person's body constitution, through discriminatory treatment and personalized treatment methods. Chinese medicine doctors collect patients' information to distinguish the type of TCM pattern, and then according to the different types of diagnosis of traditional Chinese medicine to decide of using herbs, acupuncture, massage and other treatment strategies. However, lacking of objective data of traditional Chinese medicine, the current research on precision medicine in Chinese medicine is still limited. The aim of this study is to establish a big database of traditional Chinese precision medicine, and use the patients with hypertension as the population to conduct research on precision medicine in Chinese medicine.This study will combine the TCM body constitutional questionnaire, tongue diagnosis, pulse diagnosis, Chinese medicine immunoassay and genetic testing. In addition, the information providing by the medical electronic medical record system of China Medical University Hospital will be connected, which include modern medical diagnosis, treatment, blood and biochemical analysis and imaging. We will combine the big data analysis and artificial intelligence interpretation technology to explore the correlation between different TCM syndrome types and gene variations in patients with hypertension and establish a database of TCM precision medicine. We will also conduct the education training and symposium to train TCM precision medical talents and promote public understanding of TCM precision medicine. This project will establish a database of traditional Chinese medicine precision medicine to provide the correlation between different TCM pattern types of patients with hypertension, the reaction to different herbal medicine, and gene mutation, and provide reference for TCM clinicians.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were diagnosed as having primary hypertension by cardiologists.
Key inclusion criteria (2 listed)
- Primary hypertension
- Older than 20 year-old
Key exclusion criteria (5 listed)
- Past history of cancer
- Hemodialysis
- Hypertension caused by renal diseases or endocrine disorders
- Pregnancy
- Patients can not received investigation of body constitution, TCM tongue examination and pulse examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between TCM body constitution and genetic variation
Time frame: 2 years
The correlation between TCM body constitution and genetic variation of patients with primary hypertension will be investigated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension, run by China Medical University Hospital 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between TCM body constitution and genetic variation (time frame: 2 years). 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 20 Jul 2022.