NCT04434924

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

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

June 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

June 24, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

June 15, 2020

Last Update Submit

July 18, 2022

Conditions

Keywords

Traditional Chinese precision medicineChinese medicine immunoassayBody constitutiongenetic variation

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients were diagnosed as having primary hypertension by cardiologists.

You may qualify if:

  • Primary hypertension
  • Older than 20 year-old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 17, 2020

Study Start

June 24, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations