Complementary Role of Herbal Traditional Chinese Medicine in Management of Mild to Moderate Childhood Asthma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Pediatric Asthma Quality of Life Change from Baseline at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Paediatric Lung Tonic (PLTG)
Traditional Chinese Medicine (TCM) in granules dosage form to be dissolved for consumption.
干预措施: PLTG (Other)
PLTG Placebo
Starch granules with 10% TCM to mimic the colour, taste and smell of active TCM.
干预措施: Placebo (Other)
结局指标
主要结局
Pediatric Asthma Quality of Life Change from Baseline at 3 months
时间窗: 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.
次要结局
- Airway Inflammation Change from Baseline at 3 months(3 months)
- Pulmonary Lung Function Change from Baseline at 3 months(3 months)
- Incidence of Treatment-Emergent Liver Associated Adverse Events(3 months)
- Incidence of Treatment-Emergent Renal Associated Adverse Events(3 months)