Clinical trial NCT05640570: 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
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preventive Effectiveness
Elderly With Qi-deficiency Constitution
The Individualized Jade Wind-Barrier Herbal Tea Bag
Common Cold
Pragmatic Randomized Controlled Trial
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
First posted: 2022-12-07
Enrollment: 304
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Aged 65 years old or above,
2. HK residents capable of consenting and have agreed to participate,
3. Meet the assessment criteria of Qi-deficiency Constitution in TCMECQ-C at screening,
4. The number of the incidence of the common cold ≥ 1 times/year,
5. Able to intake the individualized Jade Wind-Barrier Herbal Tea Bag and complete the trial-related records/questionnaires and also withdraw blood.

Exclusion Criteria:

1. Not fulfilling the above inclusion criteria,
2. Not assessed to be Qi-deficiency Constitution,
3. 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,
4. 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,
5. 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,
6. 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,
7. Allergic to Chinese Herbal Medicine (Astragali Radix (Zhi Huangqi), Saposhnikoviae Radix (Fangfeng), Atractylodes macrocephala Koidz (Baizhu), Nelumbinis Folium (Heye), Chrysanthemum morifolium Ramat (Juhua)),
8. Taking Chinese Herbal Medicine or drugs to manage their health problems within two weeks and cannot stop the treatment during the study,
9. Have an abnormal liver and renal function analyzed results after randomization at screening.

Primary outcomes:
measure: Change in the incidence rate of the common cold from baseline (week 0) to the end of the intervention (week 13).
timeFrame: 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).
measure: 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).
timeFrame: Around 30 minutes is needed to fill in both the baseline and after intervention CFQCQ.
Secondary outcomes:
measure: 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).
timeFrame: Around 30 minutes is needed to fill in both the baseline and after intervention Incidence of Common Cold Record (if participants catch cold).
measure: 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).
timeFrame: Around 30 minutes is needed to fill in both the baseline and after intervention TCMSSM.
measure: 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).
timeFrame: 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.
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: School of Chinese Medicine, Hong Kong Baptist University
state: Hong Kong
Study officials:
affiliation: Hong Kong Baptist University
name: Zhao-xiang Bian, PhD
role: PRINCIPAL_INVESTIGATOR
References: