Asthma in Children Clinical Trial
Official title:
Complementary Role of Herbal Traditional Chinese Medicine in Management of Mild to Moderate Childhood Asthma
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
| Recruiting |
NCT05734261 -
Forced Oscillations Technique During a Metacholine Test in Children
|
N/A | |
| Recruiting |
NCT06044051 -
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
|
N/A | |
| Completed |
NCT04896502 -
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
|
N/A | |
| Completed |
NCT03503812 -
Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches
|
N/A | |
| Recruiting |
NCT06003569 -
Reducing Asthma Attacks in Disadvantaged School Children With Asthma
|
N/A | |
| Not yet recruiting |
NCT05902702 -
Isotonic Saline for Children With Bronchiolitis
|
N/A | |
| Not yet recruiting |
NCT05547477 -
Continuous EMG Measurements in Children With Asthma During Sleep
|
||
| Completed |
NCT04388098 -
Oral Health Status of Asthmatic Children
|
||
| Terminated |
NCT03586544 -
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
|
Phase 4 | |
| Recruiting |
NCT04821908 -
Consequences of COVID 19 Pandemic on Childhood Asthma
|
||
| Not yet recruiting |
NCT03277170 -
Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations
|
Phase 2 | |
| Enrolling by invitation |
NCT06239844 -
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
|
N/A | |
| Not yet recruiting |
NCT05997784 -
Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
|
||
| Not yet recruiting |
NCT05974917 -
Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
|
||
| Recruiting |
NCT05366309 -
Performance and Adherence in Children Using Spacers
|
N/A | |
| Completed |
NCT05684926 -
COVID-19 Pandemic Asthma Child Telerehabilitation Yoga
|
N/A | |
| Recruiting |
NCT04166344 -
A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma
|
N/A | |
| Completed |
NCT05576142 -
Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
|
||
| Completed |
NCT03673618 -
Soluble Corn Fiber Supplementation for Asthma
|
Phase 2 |