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The Preventive Effectiveness of the Individualized Jade Wind-Barrier Herbal Tea Bag on the Common Cold in Elderly With Qi-deficiency Constitution (CCJWBT): A Pragmatic Randomized Controlled Trial (CCJWBT)

Primary Purpose

Preventive Effectiveness, Elderly With Qi-deficiency Constitution, The Individualized Jade Wind-Barrier Herbal Tea Bag

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
The individualized Jade Wind-Barrier Herbal Tea Bag
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preventive Effectiveness

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 65 years old or above, HK residents capable of consenting and have agreed to participate, Meet the assessment criteria of Qi-deficiency Constitution in TCMECQ-C at screening, The number of the incidence of the common cold ≥ 1 times/year, Able to intake the individualized Jade Wind-Barrier Herbal Tea Bag and complete the trial-related records/questionnaires and also withdraw blood. Exclusion Criteria: Not fulfilling the above inclusion criteria, Not assessed to be Qi-deficiency Constitution, Having serious mental and behavioral disorders that are unable to intake the individualized Jade Wind-Barrier Herbal Tea Bag, complete the trial-related records/questionnaires and withdraw blood, Having neurological disorders such as dementia etc. that are unable to intake the individualized Jade Wind-Barrier Herbal Tea Bag and complete the trial-related records/questionnaires and withdraw blood, Having serious diseases with undesirable conditions that are unable to intake the individualized Jade Wind-Barrier Herbal Tea Bag and complete the trial-related records/questionnaires and withdraw blood, Other conditions that are unable to intake the individualized Jade Wind-Barrier Herbal Tea Bag and complete the trial-related records/questionnaires and withdraw blood, Allergic to Chinese Herbal Medicine (Astragali Radix (Zhi Huangqi), Saposhnikoviae Radix (Fangfeng), Atractylodes macrocephala Koidz (Baizhu), Nelumbinis Folium (Heye), Chrysanthemum morifolium Ramat (Juhua)), Taking Chinese Herbal Medicine or drugs to manage their health problems within two weeks and cannot stop the treatment during the study, Have an abnormal liver and renal function analyzed results after randomization at screening.

Sites / Locations

  • School of Chinese Medicine, Hong Kong Baptist University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The individualized Jade Wind-Barrier Herbal Tea Bag (JWBT) arm

Control arm

Arm Description

Outcomes

Primary Outcome Measures

Change in the incidence rate of the common cold from baseline (week 0) to the end of the intervention (week 13).
Comparing Q14 incidence frequency of the common cold in the TCM Body Constitution Questionnaire (For Elderly People) (Cantonese version) (TCMECQ-C) with Q4 incidence days (convert to incidence frequency) of the common cold in the Incidence of Common Cold Record (if participants catch cold).
Change in the reductive ratio of the total score of CFQCQ among the HK Qi- deficiency Constitution elderly from baseline (week 0) to the end of intervention (week 13).
Comparing the difference between the baseline score of the Clinical Features of the Qi-deficiency Constitution Questionnaire (CFQCQ) and the after intervention score of the CFQCQ.

Secondary Outcome Measures

Changes in the persistence time of incident common cold among the HK Qi-deficiency Constitution elderly from baseline (week 0) to the end of intervention (week 13).
Comparing the difference between 1st month with the 3rd month on Q4 number of incidence days of the common cold (persistence time of incident common cold) in the Incidence of Common Cold Record (if participants catch cold).
Change in intervention index of the total score of TCMSSM among the HK Qi-deficiency Constitution elderly (if catch cold) from baseline (week 0) to the end of intervention (week 13).
Comparing the difference between the baseline and after intervention's intervention index of the total score of the Traditional Chinese Medicine Syndrome Scoring Method Questionnaire (TCMSSMQ).
Changes in the ranges of immune markers (Ig G, Ig A and Ig M) function analysis from baseline (week 0) to the end of intervention (week 13).
Comparing the difference between the ranges of immune markers (IgG, IgA and IgM) function analysis from baseline (week 0) to the end of intervention (week 13).

Full Information

First Posted
November 29, 2022
Last Updated
November 29, 2022
Sponsor
Hong Kong Baptist University
Collaborators
The Hong Kong Jockey Club Charities Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05640570
Brief Title
The Preventive Effectiveness of the Individualized Jade Wind-Barrier Herbal Tea Bag on the Common Cold in Elderly With Qi-deficiency Constitution (CCJWBT): A Pragmatic Randomized Controlled Trial
Acronym
CCJWBT
Official Title
The Preventive Effectiveness of the Individualized Jade Wind-Barrier Herbal Tea Bag on the Common Cold in Elderly With Qi-deficiency Constitution (CCJWBT): A Pragmatic Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
The Hong Kong Jockey Club Charities Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Objectives Based on the individualized Jade Wind-Barrier Herbal Tea Bag intake after randomization, to evaluate the relationship of the individualized Jade Wind-Barrier Herbal Tea Bag intake and the improvement of Qi-deficiency Constitution on the common cold-associated outcomes. Specific Aims 1: To compare the incidence and recurrence of the common cold by the individualized Jade Wind-Barrier Herbal Tea Bag intake strategies (intake 3-month individualized Jade Wind-Barrier Herbal Tea Bag vs. no intake throughout the same trial period) in the HK Qi-deficiency Constitution elderly. Specific Aims 2: To determine the immunological index(es) and function changes by the intake strategies (intake 3-month individualized Jade Wind-Barrier Herbal Tea Bag vs. no intake throughout the same trial period) on the common cold among HK Qi-deficiency Constitution elderly. Specific Aims 3: To assess the change in the reductive ratio of the total scores of the Clinical Features of the Qi-deficiency Constitution Questionnaire by the individualized Jade Wind-Barrier Herbal Tea Bag intake strategies (intake 3-month individualized Jade Wind-Barrier Herbal Tea Bag vs. no intake throughout the same trial period) in the HK Qi-deficiency Constitution elderly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preventive Effectiveness, Elderly With Qi-deficiency Constitution, The Individualized Jade Wind-Barrier Herbal Tea Bag, Common Cold, Pragmatic Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The individualized Jade Wind-Barrier Herbal Tea Bag (JWBT) arm
Arm Type
Experimental
Arm Title
Control arm
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
The individualized Jade Wind-Barrier Herbal Tea Bag
Intervention Description
The individualized Jade Wind Barrier Herbal Tea Bag is composed of Astragali Radix (Zhi Huangqi) 4g, Saposhnikoviae Radix (Fangfeng) 2g, Atractylodes macrocephala Koidz (Baizhu) 2g, Nelumbinis Folium (Heye) 1g, Chrysanthemum morifolium Ramat (Juhua) 1g.
Primary Outcome Measure Information:
Title
Change in the incidence rate of the common cold from baseline (week 0) to the end of the intervention (week 13).
Description
Comparing Q14 incidence frequency of the common cold in the TCM Body Constitution Questionnaire (For Elderly People) (Cantonese version) (TCMECQ-C) with Q4 incidence days (convert to incidence frequency) of the common cold in the Incidence of Common Cold Record (if participants catch cold).
Time Frame
Around 30 minutes is needed to fill in both TCM Body Constitution Questionnaire (For Elderly People) (Cantonese version) (TCMECQ-C) and the Incidence of Common Cold Record (if participants catch cold).
Title
Change in the reductive ratio of the total score of CFQCQ among the HK Qi- deficiency Constitution elderly from baseline (week 0) to the end of intervention (week 13).
Description
Comparing the difference between the baseline score of the Clinical Features of the Qi-deficiency Constitution Questionnaire (CFQCQ) and the after intervention score of the CFQCQ.
Time Frame
Around 30 minutes is needed to fill in both the baseline and after intervention CFQCQ.
Secondary Outcome Measure Information:
Title
Changes in the persistence time of incident common cold among the HK Qi-deficiency Constitution elderly from baseline (week 0) to the end of intervention (week 13).
Description
Comparing the difference between 1st month with the 3rd month on Q4 number of incidence days of the common cold (persistence time of incident common cold) in the Incidence of Common Cold Record (if participants catch cold).
Time Frame
Around 30 minutes is needed to fill in both the baseline and after intervention Incidence of Common Cold Record (if participants catch cold).
Title
Change in intervention index of the total score of TCMSSM among the HK Qi-deficiency Constitution elderly (if catch cold) from baseline (week 0) to the end of intervention (week 13).
Description
Comparing the difference between the baseline and after intervention's intervention index of the total score of the Traditional Chinese Medicine Syndrome Scoring Method Questionnaire (TCMSSMQ).
Time Frame
Around 30 minutes is needed to fill in both the baseline and after intervention TCMSSM.
Title
Changes in the ranges of immune markers (Ig G, Ig A and Ig M) function analysis from baseline (week 0) to the end of intervention (week 13).
Description
Comparing the difference between the ranges of immune markers (IgG, IgA and IgM) function analysis from baseline (week 0) to the end of intervention (week 13).
Time Frame
Around one month respectively to complete the baseline and after trial blood withdrawal. Another one month for the corresponding ELISA test on IgG, IgA and IgM.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 65 years old or above, HK residents capable of consenting and have agreed to participate, Meet the assessment criteria of Qi-deficiency Constitution in TCMECQ-C at screening, The number of the incidence of the common cold ≥ 1 times/year, Able to intake the individualized Jade Wind-Barrier Herbal Tea Bag and complete the trial-related records/questionnaires and also withdraw blood. Exclusion Criteria: Not fulfilling the above inclusion criteria, Not assessed to be Qi-deficiency Constitution, Having serious mental and behavioral disorders that are unable to intake the individualized Jade Wind-Barrier Herbal Tea Bag, complete the trial-related records/questionnaires and withdraw blood, Having neurological disorders such as dementia etc. that are unable to intake the individualized Jade Wind-Barrier Herbal Tea Bag and complete the trial-related records/questionnaires and withdraw blood, Having serious diseases with undesirable conditions that are unable to intake the individualized Jade Wind-Barrier Herbal Tea Bag and complete the trial-related records/questionnaires and withdraw blood, Other conditions that are unable to intake the individualized Jade Wind-Barrier Herbal Tea Bag and complete the trial-related records/questionnaires and withdraw blood, Allergic to Chinese Herbal Medicine (Astragali Radix (Zhi Huangqi), Saposhnikoviae Radix (Fangfeng), Atractylodes macrocephala Koidz (Baizhu), Nelumbinis Folium (Heye), Chrysanthemum morifolium Ramat (Juhua)), Taking Chinese Herbal Medicine or drugs to manage their health problems within two weeks and cannot stop the treatment during the study, Have an abnormal liver and renal function analyzed results after randomization at screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao-xiang Bian, PhD
Organizational Affiliation
Hong Kong Baptist University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Chinese Medicine, Hong Kong Baptist University
City
Hong Kong
State/Province
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

The Preventive Effectiveness of the Individualized Jade Wind-Barrier Herbal Tea Bag on the Common Cold in Elderly With Qi-deficiency Constitution (CCJWBT): A Pragmatic Randomized Controlled Trial

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