The effect of a Chinese herbal formula on the quality of life and immune system of people who have asthma, a condition where the immune system overreacts to allergens or environmental stimuli and causes symptoms like cough, wheezing and shortness of breath

Evaluation of Bu-Zhong-Yi-Qi-Tang (BZYQT) on quality of life and immune modulation in asthma patients: a randomized, double-blind, placebo-controlled pilot trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57184184

Enrollment

Registered

2025-04-12

Start date

2019-01-21

Completion date

Unknown

Last updated

2025-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment with a Chinese herbal formula for patients with asthma Respiratory

Interventions

Patients with asthma were randomly assigned to receive either BZYQT (oral, 12 grams per day) or placebo for 12 weeks. Total duration of follow-up for all study arms: 16 weeks Details of the random

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged between 20 and 65 years with controlled or partly controlled asthma. 2. Diagnosed according to the Taiwan Asthma Guidelines (based on the 2009 GINA revision). 3. Participants were required to be capable of correctly performing pulmonary function tests (spirometry).

Exclusion criteria

Exclusion criteria: 1. Patients currently undergoing treatment with oral or injectable corticosteroids, or other immunomodulatory agents. 2. Patients who had discontinued such medications within one month prior to the study. 3. Individuals with active infectious diseases, including pneumonia, sinusitis, or bronchitis. 4. Patients with dementia or other psychiatric disorders that could interfere with their ability to complete the required study questionnaires. 5. Individuals with a history of allergy to TCM, poor medication adherence, or a history of previous adverse reactions. 6. Patients with severe organ dysfunction, such as heart failure, liver failure, liver cirrhosis, or chronic kidney disease with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m².

Design outcomes

Primary

Measure	Time frame
Quality of life, measured using the Asthma Quality of Life Questionnaire (AQLQ) at week 0 (before receiving BZYQT or placebo), week 6 (six weeks after starting BZYQT or placebo), week 12 (12 weeks after starting BZYQT or placebo, end of treatment), and week 16 (end of the trial)	—

Secondary

Measure	Time frame
1. Immune and inflammatory markers such as IgE, eosinophil counts, measured by blood sample at weeks 0,6,12, and 16 2. Asthma-related cytokines (IL-4, IL-5, IL-10, and IL-13), and inflammatory mediators (IL-8, LTC4, sICAM-1, and PGE2) measured by blood sample at weeks 0,6, and 12 3. Safety profiles, including CBC and liver and kidney function (ALT and creatinine), were also carried out at weeks 0,6,12, and 16	—

Measure

Time frame

1. Immune and inflammatory markers such as IgE, eosinophil counts, measured by blood sample at weeks 0,6,12, and 16 2. Asthma-related cytokines (IL-4, IL-5, IL-10, and IL-13), and inflammatory mediators (IL-8, LTC4, sICAM-1, and PGE2) measured by blood sample at weeks 0,6, and 12 3. Safety profiles, including CBC and liver and kidney function (ALT and creatinine), were also carried out at weeks 0,6,12, and 16

—

Countries

Taiwan

Contacts

Public ContactSien-Hung Yang

dryang@mail.cgu.edu.tw+886-3-2118800#5101

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026