CHM Teabag Decrease Stroke Risk Among Hong Kong Elderly

Not Applicable

Recruiting

• Conditions: Stroke; Risk Reduction; Elderly
• Interventions: Drug: Chinese Herbal Medicine (CHM) teabag

• Registration Number: NCT05801575
• Lead Sponsor: Hong Kong Baptist University

Brief Summary

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.

Detailed Description

This is a stepped wedge cluster randomized controlled trial design. This study aims to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population.

A total of 912 participants will be recruited from 9 clinics. 2\~3 clinics will represent a cluster unit. The stepped wedge design will consist of four groups each containing four randomly allocated cluster units, allocated to either 4, 8, 12, or 16 weeks of the intervention. The intervention is Chinese herbal teabag treatment, which will consist of five Chinese herbs (a total of 10g). The first group will receive 16 weeks of the intervention, the second group will receive 12 weeks, the third group will receive 8 weeks, and the forth group will receive 4 weeks.

The primary outcome measure is the stroke risk estimated with Automatic Retinal Image Analysis (ARIA). Secondary outcome measures include Framingham Stroke Risk Score (FSRS), cognitive impairment risk estimated with ARIA, Hong Kong version of the Montreal Cognitive Assessment (MoCA), Constitution in Chinese Medicine Questionnaire (CCMQ), World Health Organization Quality-of-Life Scale (WHOQOL-BREF), Health-promoting lifestyle profile II (HPLP-II), and adverse events.

Study Timeline

• Study Start: 2023-02-02
• Study First Submitted: 2023-02-05
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-08-30
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 912

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese Herbal Medicine (CHM) teabag, Cluster 1	Chinese Herbal Medicine (CHM) teabag	Intervention Cluster 1 is the first intervention arm designed to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population. It will receive 16 weeks of the intervention.
CHM teabag, Cluster 2	Chinese Herbal Medicine (CHM) teabag	Intervention Cluster 2 is the second intervention arm designed to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population. It will receive 12 weeks of the intervention.
CHM teabag, Cluster 4	Chinese Herbal Medicine (CHM) teabag	Intervention Cluster 4 is the fourth intervention arm designed to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population. It will receive 4 weeks of the intervention.
CHM teabag, Cluster 3	Chinese Herbal Medicine (CHM) teabag	Intervention Cluster 3 is the third intervention arm designed to examine the efficacy and safety of CHM teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population. It will receive 8 weeks of the intervention.

Primary Outcome Measures

Name	Time	Method
Automatic Retinal Image Analysis (ARIA).	16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events	16 weeks	All adverse events (AEs) will be recorded.
Framingham Stroke Risk Score (FSRS)	16 weeks	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.
Cognitive impairment risk	16 weeks	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.
Montreal Cognitive Assessment (MoCA)	16 weeks	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.
Constitution in Chinese Medicine Questionnaire (CCMQ)	16 weeks	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.
World Health Organization Quality-of-Life Scale (WHOQOL-BREF)	16 weeks	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.
Health-promoting lifestyle profile II (HPLP-II)	16 weeks	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.

Trial Locations

Locations (1)

Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre; 🇨🇳 Hong Kong, China