Asthma in ChildrenPhase 2TraCMAstNCT03645889
Traditional Chinese Medicine in Management of Childhood Asthma
A Phase 2 study testing PLTG in people with Asthma in Children, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- PLTG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Oct 2018to Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Han Hui Cheong, PhD, +6563943735, cheong.han.hui@kkh.com.sg
Rupini Piragasam, BSc, +6563948246, Rupini.Piragasam@kkh.com.sg
About this study
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- PLTG, Placebo
- Keywords
- Traditional Chinese Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLTGOther
A combination of 13 herbal granules
PlaceboOther
90% starch filler and 10% PLTG
| Study group | Role | What they receive |
|---|---|---|
| Paediatric Lung Tonic (PLTG) | Experimental | Traditional Chinese Medicine (TCM) in granules dosage form to be dissolved for consumption. Receives: Other: PLTG |
| PLTG Placebo | Placebo comparator | Starch granules with 10% TCM to mimic the colour, taste and smell of active TCM. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
Pulmonary Lung Function Change from Baseline at 3 months
Improvement in pulmonary lung function will be assessed using spirometry test.
Measured: 3 months
Incidence of Treatment-Emergent Liver Associated Adverse Events
Clinical biochemistry tests to assess liver functions
Measured: 3 months
Incidence of Treatment-Emergent Renal Associated Adverse Events
Clinical biochemistry tests to assess renal functions
Measured: 3 months
Airway Inflammation Change from Baseline at 3 months
Reduction in factional exhaled nitric oxide as an indicator for improvement in airway inflammation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start15 Oct 2018
- Primary completionMar 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Singapore Thong Chai Medical Institution
- Responsible party
- Sponsor
- Investigators
- Oon Hoe Teoh, MBBS, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645889
- Sponsor's protocol ID
- 2017/3129
- Acronym
- TraCMAst
- Status last verified
- Dec 2017
- First submitted
- 28 Dec 2017
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Role of Herbal Traditional Chinese Medicine in Management of Mild to Moderate Childhood Asthma
- ClinicalTrials.gov ID
- NCT03645889
- Acronym / sponsor ID
- TraCMAst / 2017/3129
- Conditions
- Asthma in Children
- Keywords
- Traditional Chinese Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Singapore Thong Chai Medical Institution
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Paediatric Lung Tonic (PLTG) | Experimental | Other: PLTGTraditional Chinese Medicine (TCM) in granules dosage form to be dissolved for consumption. |
| PLTG Placebo | Placebo comparator | Other: PlaceboStarch granules with 10% TCM to mimic the colour, taste and smell of active TCM. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLTGA combination of 13 herbal granules | Other | Paediatric Lung Tonic (PLTG) |
| Placebo90% starch filler and 10% PLTG | Other | PLTG Placebo |
Primary outcome
Pediatric Asthma Quality of Life Change from Baseline at 3 months
Time frame: 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.
4 secondary outcomes
Pulmonary Lung Function Change from Baseline at 3 months
Time frame: 3 months
Incidence of Treatment-Emergent Liver Associated Adverse Events
Time frame: 3 months
Incidence of Treatment-Emergent Renal Associated Adverse Events
Time frame: 3 months
Airway Inflammation Change from Baseline at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oon Hoe Teoh, MBBS principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLTG in people with Asthma in Children, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Hui Cheong, PhD (+6563943735, cheong.han.hui@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Asthma Quality of Life Change from Baseline at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.