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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06342206
Other study ID # CMUH111-REC2-144
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 8, 2022
Est. completion date September 7, 2024

Study information

Verified date March 2024
Source China Medical University Hospital
Contact Lun-Chien Lo, profession
Phone 886-04-22053366
Email cmulclo@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cerebral infarction is the second cause of death and the third cause of disability. More than 13.7 million patients worldwide are diagnosed with stroke every year, and the number of deaths is 5.5 million, of which ischemic stroke is the major type, accounting for 87%. Sequelae of stroke are problems that require long-term medical care. If we can intervene and assist with Traditional Chinese Medicine (TCM) at early stage, it will be a great boon for patients. In clinical practice, TCM collects data as the basis for diagnosis through the four diagnostic methods-look, listen, question, and feel the pulse. Among these, tongue diagnosis and pulse diagnosis belong to the categories of look and feel the pulse. At present, the objective examination instruments of TCM developed are mainly tongue diagnostic instruments and pulse diagnostic instruments. Therefore, we hope to utilize tongue and pulse diagnoses as the main reference to analyze the changes in ischemic stroke stages. The data of this study are collected from China Medical University Hospital and YuanRung Hospital-for further statistical analysis. Ischemic stroke patients (ICD-10: I63) who were hospitalized within 1 week from the date of diagnosis were eligible to join this research project. Tongue and pulse examinations were collected once per week within 1 month. A total of 4 tongue-pulse examinations were collected in each case, which were categorized into acute stage (24 hours to 1 week), subacute stage (1 to 3 weeks) and chronic stage (more than 3 weeks). [30] This research is to study the changes of tongue and pulse diagnoses in acute, subacute and chronic stages among ischemic patients who receive TCM diagnosis and treatment. Through utilizing objective evaluation of Chinese and Western medical examination instruments, we hope to establish clear diagnostic standards for TCM syndrome types, so as to evaluate the efficacy of clinical diagnosis and treatment. The goal is to improve the quality of TCM care and to provide Chinese and Western integrated treatment for stroke patients in the future. This research can also serve as a reference for related TCM research and development.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date September 7, 2024
Est. primary completion date September 21, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Patients older than 40 years of age, who acted in concert with the complete examination and answered the questionnaire. 2. Participants were diagnosed as ischemic stroke (ICD-10:I63) by neurologist, and were approved by head CT or MRI examination. 3. Those with a stable vital sign after being examined by an internal medicine specialist 4. Those who experience a cerebral vascular accident within 10 days of the consultation 5. Signing the agreement document to join the research program Exclusion Criteria: 1. Those with an unstable vital sign 2. Patients who were unable to protrude their tongue or the protruding length was insufficient 3. Those at risk of jaw dislocation 4. Those with an arteriovenous shunt or fistula 5. Those who experience seizures 6. Those with poor cognition and communication

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan YuanRung Hospital Changhua

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences between tongue diagnosis and pulse diagnosis in acute and chronic stroke patients To compare the differences between tongue and pulse diagnosis in acute, subacute and chronic phases of stroke patients using statistical methods. Beginning September 2022 through October 2024
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