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StrokeNCT05801575

CHM Teabag Decrease Stroke Risk Among Hong Kong Elderly

A study testing Chinese Herbal Medicine (CHM) teabag in people with Stroke and Risk Reduction, run by Hong Kong Baptist University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 54 to 84 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Risk Reduction, Elderly
What is being tested?
Chinese Herbal Medicine (CHM) teabag
Could I receive a placebo?
No, everyone receives an active treatment
How many people
912 participants
Where
1 siteChina
Study dates
2 Feb 2023to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 54 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

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

    Hong Kong

    Zhao-xiang Bian, PhD, (852) 3411 2905, bzxiang@hkbu.edu.hk

    Jialing Zhang, Mphil, BCM, (852) 3411 5024, zhangjialing@hkbu.edu.hk

    Recruiting

Other trials in China

About this study

Official title: Efficacy of the CHM Teabag in Decreasing Stroke Risk Among Elderly People in Hong Kong: A Stepped Wedge Cluster Randomized Trial

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.

Read the 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.

Being tested
Chinese Herbal Medicine (CHM) teabag
Keywords
Stroke, Risk Reduction, Chinese Herbal Medicine, Automatic Retinal Image Analysis, Teabag
Medical subject headings
Stroke, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05801575
Study groupRoleWhat they receive
Chinese Herbal Medicine (CHM) teabag, Cluster 1ExperimentalIntervention 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.
Receives: Drug: Chinese Herbal Medicine (CHM) teabag
CHM teabag, Cluster 2ExperimentalIntervention 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.
Receives: Drug: Chinese Herbal Medicine (CHM) teabag
CHM teabag, Cluster 3ExperimentalIntervention 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.
Receives: Drug: Chinese Herbal Medicine (CHM) teabag
CHM teabag, Cluster 4ExperimentalIntervention 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.
Receives: Drug: Chinese Herbal Medicine (CHM) teabag

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 weeks

Secondary outcomes (7)

  1. 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.

    Measured: 16 weeks

  2. 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.

    Measured: 16 weeks

  3. 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.

    Measured: 16 weeks

  4. 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.

    Measured: 16 weeks

  5. 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.

    Measured: 16 weeks

  6. 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.

    Measured: 16 weeks

  7. Adverse events

    All adverse events (AEs) will be recorded.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start2 Feb 2023
  3. Primary completion30 Aug 2023 (estimated)
  4. Study completion31 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a stepped wedge cluster randomized controlled trial design.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
912 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05801575
Sponsor's protocol ID
REC/22-23/0290
Status last verified
Mar 2023
First submitted
5 Feb 2023
Last updated
6 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 9142060

  • 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.

    PubMed 22052510

  • 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.

    PubMed 28154098

  • 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.

    PubMed 18117474

  • 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.

    PubMed 50653

  • 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.

    PubMed 28057562

  • 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.

    PubMed 27068777

  • 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.

    PubMed 26754623

  • 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.

    PubMed 35628812

Questions about this trial

What is this clinical trial studying?

A study testing Chinese Herbal Medicine (CHM) teabag in people with Stroke and Risk Reduction, run by Hong Kong Baptist University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Automatic Retinal Image Analysis (ARIA). (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05801575, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.

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