Traditional Chinese Medicine in Management of Childhood Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2021-09-30

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.

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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.

Conditions

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paediatric Lung Tonic (PLTG)

Traditional Chinese Medicine (TCM) in granules dosage form to be dissolved for consumption.

Group Type EXPERIMENTAL

PLTG

Intervention Type OTHER

A combination of 13 herbal granules

PLTG Placebo

Starch granules with 10% TCM to mimic the colour, taste and smell of active TCM.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

90% starch filler and 10% PLTG

Interventions

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PLTG

A combination of 13 herbal granules

Intervention Type OTHER

Placebo

90% starch filler and 10% PLTG

Intervention Type OTHER

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No