NCT05801575

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
912

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

February 5, 2023

Last Update Submit

March 30, 2023

Conditions

StrokeRisk ReductionElderly

Keywords

StrokeRisk ReductionChinese Herbal MedicineAutomatic Retinal Image AnalysisTeabag

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Framingham Stroke Risk Score (FSRS)

    16 weeks

  • Cognitive impairment risk

    16 weeks

  • Montreal Cognitive Assessment (MoCA)

    16 weeks

  • Constitution in Chinese Medicine Questionnaire (CCMQ)

    16 weeks

  • World Health Organization Quality-of-Life Scale (WHOQOL-BREF)

    16 weeks

  • +2 more secondary outcomes

Study Arms (4)

Chinese Herbal Medicine (CHM) teabag, Cluster 1

EXPERIMENTAL

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.

Drug: Chinese Herbal Medicine (CHM) teabag

CHM teabag, Cluster 2

EXPERIMENTAL

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.

Drug: Chinese Herbal Medicine (CHM) teabag

CHM teabag, Cluster 3

EXPERIMENTAL

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.

Drug: Chinese Herbal Medicine (CHM) teabag

CHM teabag, Cluster 4

EXPERIMENTAL

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.

Drug: Chinese Herbal Medicine (CHM) teabag

Interventions

Chinese Herbal Medicine (CHM) teabagDRUG

Each teabag contains five herbs: Radix et Rhizoma (三七, Sanqi), Moutan Cortex (牡丹皮, Mudanpi), Puerariae Lobatae Radix (葛根, Gegen), Rosae Rugosae Flos (玫瑰花, Meiguihua), and Citri Grandis Exocarpium (化橘紅, Huajuhong). These herbs are benefit to promoting blood circulation, dredging meridians and collaterals, strengthening spleen, regulating qi and decreasing phlegm in Chinese Medicine theories.

CHM teabag, Cluster 2CHM teabag, Cluster 3CHM teabag, Cluster 4Chinese Herbal Medicine (CHM) teabag, Cluster 1

Eligibility Criteria

Age54 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hong Kong, China

RECRUITING

Related Publications (9)

  • Murray CJ, Lopez AD. Mortality by cause for eight regions of the world: Global Burden of Disease Study. Lancet. 1997 May 3;349(9061):1269-76. doi: 10.1016/S0140-6736(96)07493-4.

    PMID: 9142060BACKGROUND

  • 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.

    PMID: 22052510BACKGROUND

  • Boehme AK, Esenwa C, Elkind MS. Stroke Risk Factors, Genetics, and Prevention. Circ Res. 2017 Feb 3;120(3):472-495. doi: 10.1161/CIRCRESAHA.116.308398.

    PMID: 28154098BACKGROUND

  • ALPERS BJ, FORSTER FM, HERBUT PA. Retinal, cerebral and systemic arteriosclerosis; a histopathologic study. Arch Neurol Psychiatry. 1948 Nov;60(5):440-56. doi: 10.1001/archneurpsyc.1948.02310050017002. No abstract available.

    PMID: 18117474BACKGROUND

  • Goto I, Katsuki S, Ikui H, Kimoto K, Mimatsu T. Pathological studies on the intracerebral and retinal arteries in cerebrovascular and noncerebrovascular diseases. Stroke. 1975 May-Jun;6(3):263-9. doi: 10.1161/01.str.6.3.263.

    PMID: 50653BACKGROUND

  • Cheung CY, Ikram MK, Chen C, Wong TY. Imaging retina to study dementia and stroke. Prog Retin Eye Res. 2017 Mar;57:89-107. doi: 10.1016/j.preteyeres.2017.01.001. Epub 2017 Jan 3.

    PMID: 28057562BACKGROUND

  • Guo VY, Cao B, Wu X, Lee JJW, Zee BC. Prospective Association between Diabetic Retinopathy and Cardiovascular Disease-A Systematic Review and Meta-analysis of Cohort Studies. J Stroke Cerebrovasc Dis. 2016 Jul;25(7):1688-1695. doi: 10.1016/j.jstrokecerebrovasdis.2016.03.009. Epub 2016 Apr 8.

    PMID: 27068777BACKGROUND

  • 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.

    PMID: 26754623BACKGROUND

  • 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.

    PMID: 35628812BACKGROUND

MeSH Terms

Conditions

StrokeRisk Reduction Behavior

Interventions

Rab geranylgeranyltransferase

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In this stepped wedge design trial, the participants will be aware of the transition from no intervention period to intervention period, therefore it is unlikely to blind participants. Outcome assessors will be blinded to reduce the introduction of bias into the assessments.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a stepped wedge cluster randomized controlled trial design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2023

First Posted

April 6, 2023

Study Start

February 2, 2023

Primary Completion

August 30, 2023

Study Completion

October 31, 2023

Last Updated

April 6, 2023

Record last verified: 2023-03

Locations

CN(1)