Asthma in Children
Conditions
Keywords
Traditional Chinese Medicine
Brief summary
Bronchial Asthma is a common childhood chronic disease characterized by chronic inflammation of the airways. Frequent relapse of asthma has serious impacts on the child's growth, impairs quality of life (QoL) and mortality, posing a huge economic burden on both family and society. According to Traditional Chinese Medicine (TCM) principles and theory, the main reason for children suffering from asthma are congenital deficiencies at birth which were not corrected and/or lack of appropriate care in the early childhood, leading to insufficiency of the lung, spleen and kidney, resulting in susceptibility to external pathogenic factors. During the interval phase of the illness, wheezing is not prominent and the Lung-Spleen Qi Deficiency (LSQD) syndrome is most commonly seen. TCM treatment aims to strengthen the body's immune system by nourishing the spleen, replenishing Qi(vital energy), tonifying the lungs and strengthening the exterior, thereby reducing incidences of relapse and improve QoL. It is hypothesized that TCM has adjuvant roles in the management of mild-moderate childhood asthma. Hence the primary aim of this study is to investigate the efficacy of using herbal TCM as adjuvant therapy in the management of symptoms and QoL in asthmatic patients. A randomized, double-blind cross-sectional, 2-arms placebo-controlled study will be carried out. Pediatric patients with mild-moderate asthma identified with LSQD will be randomized to either control or treatment group. Study participants in control group will continue their conventional western medicine (CWM) while those in TCM group will consume a decoction of herbal TCM for 12-weeks in addition to their CWM. Pulmonary function tests, Asthma Control Test, QoL and TCM questionnaires will be used as outcome measurement tools. In addition, liver and kidneys functions will be monitored for signs of toxicity.
Detailed description
It is hypothesized that herbal Traditional Chinese Medicine (TCM) has adjuvant roles in the management of mild-moderate childhood asthma. The primary aim of the study is to investigate the efficacy of using herbal TCM as adjuvant therapy in the management of symptoms and quality of life in asthmatic patients. The secondary aim of the study is to investigate the improvement in pulmonary function test (PFT) and fractional exhaled nitric oxide (FeNO) test in asthmatic patients taking herbal TCM adjuvant therapy, and to monitor the safety profile of herbal TCM with regards to renal and liver functions.
Interventions
OTHERPLTG
A combination of 13 herbal granules
OTHERPlacebo
90% starch filler and 10% PLTG
Sponsors
Singapore Thong Chai Medical Institution
KK Women's and Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomised Controlled Trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Have asthma which is partly controlled based on Global Initiative for Asthma (GINA) asthma control classification guideline and has Asthma Control Test (ACT) score ≥17 at point of recruitment. * Currently using fluticasone as the only regular inhaled corticosteroid therapy for asthma control with fluticasone dosage ≤ 250mcg/day for at least past 3 months. * Able to perform pulmonary function test * Fulfil the TCM criteria of lung-spleen qi deficiency type of asthma
Exclusion criteria
* Laboratory results for renal and liver functions outside of normal range. * Concomitant use of theophylline or montelukast. * Concomitantly or in the last 3 months taking TCM * Pregnant or lactation * Known allergic reactions to food such as peanut, seafood, egg and milk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Asthma Quality of Life Change from Baseline at 3 months | 3 months | Pediatric Asthma Quality of Life Questionnaire will be used to assess improvement in asthmatic symptoms and quality of life in patients receiving both conventional asthma treatment regimen and Traditional Chinese Medicine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Lung Function Change from Baseline at 3 months | 3 months | Improvement in pulmonary lung function will be assessed using spirometry test. |
| Incidence of Treatment-Emergent Liver Associated Adverse Events | 3 months | Clinical biochemistry tests to assess liver functions |
| Incidence of Treatment-Emergent Renal Associated Adverse Events | 3 months | Clinical biochemistry tests to assess renal functions |
| Airway Inflammation Change from Baseline at 3 months | 3 months | Reduction in factional exhaled nitric oxide as an indicator for improvement in airway inflammation. |
Countries
Singapore
Contacts
Primary ContactHan Hui Cheong, PhD
Backup ContactRupini Piragasam, BSc
Outcome results
None listed