Clinical trial NCT05801575: CHM Teabag Decrease Stroke Risk Among Hong Kong Elderly
Official title: Efficacy of the CHM Teabag in Decreasing Stroke Risk Among Elderly People in Hong Kong: A Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Risk Reduction
Elderly
Keywords: Stroke
Risk Reduction
Chinese Herbal Medicine
Automatic Retinal Image Analysis
Teabag
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 912
Sex: ALL
Minimum age (years): 54
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a stepped wedge cluster randomized controlled trial design.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Automatic Retinal Image Analysis (ARIA).
timeFrame: 16 weeks
Secondary outcomes:
measure: Framingham Stroke Risk Score (FSRS)
timeFrame: 16 weeks
measure: Cognitive impairment risk
timeFrame: 16 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 16 weeks
measure: Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: 16 weeks
measure: World Health Organization Quality-of-Life Scale (WHOQOL-BREF)
timeFrame: 16 weeks
measure: Health-promoting lifestyle profile II (HPLP-II)
timeFrame: 16 weeks
measure: Adverse events
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre
Study officials:
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