Stroke Clinical Trial
Official title:
Efficacy of the CHM Teabag in Decreasing Stroke Risk Among Elderly People in Hong Kong: A Stepped Wedge Cluster Randomized Trial
Verified date | March 2023 |
Source | Hong Kong Baptist University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This stepped wedge cluster randomized controlled trial aims to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population.
Status | Recruiting |
Enrollment | 912 |
Est. completion date | October 31, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 54 Years to 84 Years |
Eligibility | Inclusion Criteria: - Age between 54-84y. - With phlegm dampness constitution and blood stasis constitution on the TCM constitution test table. - Stable vital signs without previous history of stroke. - Sufficient sensorimotor and language competency for completing assessments. Exclusion Criteria: - Allergic history to Chinese herbal drugs or a known allergy to the ingredients of the teabag. - Taking any anticoagulants, such as warfarin. - With unconsciousness, aphasia, and cognitive dysfunction. - With a past history of brain diseases (e.g., mental illness, consciousness disorder due to head trauma, previous brain surgery, or spastic disease). - With severe heart, liver, or kidney disease or bleeding disorders. - With other serious diseases. - Cataracts or other eye diseases that affected retinal image taking. - Distressed with a flashlight or have experience with photosensitive seizures. - Pregnancy or lactation female. - Any physical examination findings, or history of any illness, or concomitant medications that, in the opinion of the study investigator, might not be suitable to participate in the study. |
Country | Name | City | State |
---|---|---|---|
China | Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Hong Kong Baptist University |
China,
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Guo VY, Chan JC, Chung H, Ozaki R, So W, Luk A, Lam A, Lee J, Zee BC. Retinal Information is Independently Associated with Cardiovascular Disease in Patients with Type 2 diabetes. Sci Rep. 2016 Jan 12;6:19053. doi: 10.1038/srep19053. — View Citation
Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011 Dec;42(12):3651-4. doi: 10.1161/STROKEAHA.111.635755. Epub 2011 Nov 3. — View Citation
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Qu Y, Lee JJ, Zhuo Y, Liu S, Thomas RL, Owens DR, Zee BC. Risk Assessment of CHD Using Retinal Images with Machine Learning Approaches for People with Cardiometabolic Disorders. J Clin Med. 2022 May 10;11(10):2687. doi: 10.3390/jcm11102687. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Automatic Retinal Image Analysis (ARIA). | The primary outcome will be the score change of stroke risk estimated with Automatic Retinal Image Analysis (ARIA). The ARIA stroke risk score is represented by a probability score which is from 0 to 1. Low risk score is less than 0.5. Moderate score is 0.5 - 0.7. High risk score is more than 0.7. | 16 weeks | |
Secondary | Framingham Stroke Risk Score (FSRS) | The Framingham Stroke Risk Score (FSRS) combines stroke risk factors to predict 10-year probability of stroke. Factors included in the FSRS are age, sex, systolic blood pressure, use of antihypertensive medications, diabetes, smoking, atrial fibrillation, left ventricular hypertrophy and prevalent coronary heart disease. Higher score is associated with higher stroke risk. | 16 weeks | |
Secondary | Cognitive impairment risk | The severity of WMH changes can be estimated by taking the fundus retinal image and put to the ARIA algorithm, increasing score means increasing severity. | 16 weeks | |
Secondary | Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. Scoring of HK MoCA ranges from 0 to 30 points. A score of 26 or above is considered normal. | 16 weeks | |
Secondary | Constitution in Chinese Medicine Questionnaire (CCMQ) | The CCMQ is applied to evaluate body constitution of each patient by score (Balanced Constitution, Qi-deficient Constitution, Yang-deficient Constitution, Yin-deficient Constitution, Phlegm-dampness Constitution, Damp-heat Constitution, Stagnant Blood Constitution, Stagnant Qi Constitution, and Inherited Special Constitution). Each constitution scale contains 6 to 8 items, with 1-5 numerical rating scale. The transformed score of each constitution scale is calculated. | 16 weeks | |
Secondary | World Health Organization Quality-of-Life Scale (WHOQOL-BREF) | The WHOQOL-BREF is to measure the quality of life. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Each item is rated on a 5-point (1-5) scale. Higher scores denote higher quality of life. | 16 weeks | |
Secondary | Health-promoting lifestyle profile II (HPLP-II) | The Health-Promoting Lifestyle Profile II continues to measure health promoting behavior, conceptualized as a multidimensional pattern of self-initiated actions and perceptions that serve to maintain or enhance the level of wellness, self-actualization and fulfillment of the individual. The total score of the HPLP II ranges from 52 to 208 and is measured by the mean score of the responses to all 52 HPLP items. The total HPLP II score is further classified into four levels: poor for the range 52-90, moderate for the range 91-129, good for the range 130-168, and excellent for the range 169-208. High scores in every subscale mean more frequent health-promoting behaviors. | 16 weeks | |
Secondary | Adverse events | All adverse events (AEs) will be recorded. | 16 weeks |
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