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| Name | Class |
|---|---|
| The Hong Kong Jockey Club Charities Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The individualized Jade Wind-Barrier Herbal Tea Bag (JWBT) arm | Experimental |
| |
| Control arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The individualized Jade Wind-Barrier Herbal Tea Bag | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
| 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. | Around 30 minutes is needed to fill in both the baseline and after intervention CFQCQ. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Around 30 minutes is needed to fill in both the baseline and after intervention Incidence of Common Cold Record (if participants catch cold). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhao-xiang Bian, PhD | Hong Kong Baptist University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Chinese Medicine, Hong Kong Baptist University | Hong Kong | Hong Kong | China |
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| 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). | Around 30 minutes is needed to fill in both the baseline and after intervention TCMSSM. |
| 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). | 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. |
| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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