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

NCT05640570 | Completed Phase 2

• 1 other identifier: HKBU JC 005
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Preventive Effectiveness; Elderly With Qi-deficiency Constitution; The Individualized Jade Wind-Barrier Herbal Tea Bag; Common Cold; Pragmatic Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (3)

• 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).

  Around 30 minutes is needed to fill in both the baseline and after intervention 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).

  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).

  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.

Study Arms (2)

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

EXPERIMENTAL

Drug: The individualized Jade Wind-Barrier Herbal Tea Bag

Control arm

NO INTERVENTION

Interventions

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.

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• The Hong Kong Jockey Club Charities Trust: collaborator

Study Sites (1)

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Zhao-xiang Bian, PhD

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: February 21, 2022
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-11

Locations

CN (1)