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

Hong Kong Baptist University

Status and phase: Completed; Phase 2

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

Treatments: Drug: The individualized Jade Wind-Barrier Herbal Tea Bag

Study type: Interventional

Funder types: Other

Identifiers

NCT05640570

HKBU JC 005

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

304 participants in 2 patient groups

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

Experimental group

Treatment:

Drug: The individualized Jade Wind-Barrier Herbal Tea Bag

Control arm

No Intervention group