Traditional Chinese Medicine in Management of Childhood Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Complementary Role of Herbal Traditional Chinese Medicine in Management of Mild to Moderate Childhood Asthma

Conditions
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Asthma in Children

Intervention / Treatment
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* Other: PLTG
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paediatric Lung Tonic (PLTG)<br>Traditional Chinese Medicine (TCM) in granules dosage form to be dissolved for consumption. | Other: PLTG<br>* A combination of 13 herbal granules<br>|
| Placebo Comparator: PLTG Placebo<br>Starch granules with 10% TCM to mimic the colour, taste and smell of active TCM. | Other: Placebo<br>* 90% starch filler and 10% PLTG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Asthma Quality of Life Change from Baseline at 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Lung Function Change from Baseline at 3 months | Improvement in pulmonary lung function will be assessed using spirometry test. | 3 months | 
| Incidence of Treatment-Emergent Liver Associated Adverse Events | Clinical biochemistry tests to assess liver functions | 3 months | 
| Incidence of Treatment-Emergent Renal Associated Adverse Events | Clinical biochemistry tests to assess renal functions | 3 months | 
| Airway Inflammation Change from Baseline at 3 months | Reduction in factional exhaled nitric oxide as an indicator for improvement in airway inflammation. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Chinese Medicine