CHM Teabag Decrease Stroke Risk Among Hong Kong Elderly

Hong Kong Baptist University

Status: Enrolling

Conditions: Stroke; Elderly; Risk Reduction

Treatments: Drug: Chinese Herbal Medicine (CHM) teabag

Study type: Interventional

Funder types: Other

Identifiers

NCT05801575

REC/22-23/0290

Details and patient eligibility

About

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.

Full 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.

Enrollment: 912 estimated patients

Sex: All

Ages: 54 to 84 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

912 participants in 4 patient groups

Chinese Herbal Medicine (CHM) teabag, Cluster 1

Experimental group

Description:

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.

Treatment:

Drug: Chinese Herbal Medicine (CHM) teabag

CHM teabag, Cluster 2

Experimental group

Description:

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.

Treatment:

Drug: Chinese Herbal Medicine (CHM) teabag

CHM teabag, Cluster 3

Experimental group

Description:

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.

Treatment:

Drug: Chinese Herbal Medicine (CHM) teabag

CHM teabag, Cluster 4

Experimental group

Description:

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.

Treatment:

Drug: Chinese Herbal Medicine (CHM) teabag