Clinical trial NCT03645889: Traditional Chinese Medicine in Management of Childhood Asthma
Official title: Complementary Role of Herbal Traditional Chinese Medicine in Management of Mild to Moderate Childhood Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Asthma in Children
Keywords: Traditional Chinese Medicine
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Singapore Thong Chai Medical Institution
First posted: 2018-08-24
Enrollment: 130
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pediatric Asthma Quality of Life Change from Baseline at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Pulmonary Lung Function Change from Baseline at 3 months
timeFrame: 3 months
measure: Incidence of Treatment-Emergent Liver Associated Adverse Events
timeFrame: 3 months
measure: Incidence of Treatment-Emergent Renal Associated Adverse Events
timeFrame: 3 months
measure: Airway Inflammation Change from Baseline at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Oon Hoe Teoh, MBBS
role: PRINCIPAL_INVESTIGATOR
References: