CHM Teabag Decrease Stroke Risk Among Hong Kong Elderly

March 30, 2023 updated by: ZhaoXiang Bian, Hong Kong Baptist University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

912

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhao-xiang Bian, PhD
        • Sub-Investigator:
          • Chun Hoi CHEUNG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

54 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chinese Herbal Medicine (CHM) teabag, Cluster 1
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
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.
Experimental: CHM teabag, Cluster 2
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
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.
Experimental: CHM teabag, Cluster 3
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
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.
Experimental: CHM teabag, Cluster 4
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automatic Retinal Image Analysis (ARIA).
Time Frame: 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.
16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Baptist University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2023

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/22-23/0290

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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