A Phase 2 interventional study of PLTG and Placebo in Asthma in Children, sponsored by KK Women's and Children's Hospital. Status unknown at 1 site in Singapore. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2018-11-26.
Sponsored by KK Women's and Children's Hospital · Phase 2, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 130 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →KK Women's and Children's Hospital is the lead sponsor of 136 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Traditional Chinese Medicine (TCM) in granules dosage form to be dissolved for consumption.
Other: PLTG
Starch granules with 10% TCM to mimic the colour, taste and smell of active TCM.
Other: Placebo
A combination of 13 herbal granules
90% starch filler and 10% PLTG
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.
Time frame: 3 months
Pulmonary Lung Function Change from Baseline at 3 months
Improvement in pulmonary lung function will be assessed using spirometry test.
Time frame: 3 months
Incidence of Treatment-Emergent Liver Associated Adverse Events
Clinical biochemistry tests to assess liver functions
Time frame: 3 months
Incidence of Treatment-Emergent Renal Associated Adverse Events
Clinical biochemistry tests to assess renal functions
Time frame: 3 months
Airway Inflammation Change from Baseline at 3 months
Reduction in factional exhaled nitric oxide as an indicator for improvement in airway inflammation.
Time frame: 3 months
Plan to share: No
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This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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KK Women's and Children's Hospital