Childhood AsthmaNCT05066841
Chinese Herbal Medicine Formula Combined With Inhaled Corticosteroids for the Treatment of Mild to Persistent Asthma in Children
A study testing CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) in people with Childhood Asthma, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of study is to provide an objective data for evaluating the efficacy and safety of Chinese medicine (CM) formula combined with inhaled corticosteroid in the treatment of asthmatic children. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Childhood Asthma
- What is being tested?
- CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Sep 2021to 30 Sep 2023
- Phase
- Interventional
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 4-11 years old
- GINA (Global Initiative for Asthma) guideline belong to mild to moderate asthmatic children
- regular use low dose ICS+ LABA or medium dose ICS at least one month
Who cannot join
- asthma with acute exacerbation or ever has used systemic steroids in recent one month
- psychiatric disease or behavior disorder
- ever has received Chinese herbal medicine or other traditional Chinese medicine treatment in recent two weeks
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Chieh Wang, +886963619537, u9923035@cmu.edu.tw
About this study
Official title: Chinese Herbal Medicine Formula Combined With Inhaled Corticosteroids for the Treatment of Mild to Persistent Asthma in Children: a Randomized Double-blind Placebo-controlled Trial
The purpose of study is to provide an objective data for evaluating the efficacy and safety of Chinese medicine (CM) formula combined with inhaled corticosteroid in the treatment of asthmatic children. Investigators will recruit eighty-six mild to moderate asthmatic children aged 4-11 years old with regular ICS usage and they will be randomized into two groups in this double-blind trial. Forty-three subjects will receive CM (CM group; Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and the other forty-three subjects will receive placebo (placebo group; 10% CM) for 12 weeks. Investigators will compare these two groups by questionnaires of Childhood Asthma Control Test (cACT), the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF), Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), the pulmonary function test and blood test including Complete Blood Count with Differential Count (CBC/DC), total IgE, Eosinophil Cationic Protein (ECP) and IL-4/IL-5/IL-13. Adverse events, renal and liver function test will be evaluated to investigate the safety of CM formula as well.
Read the detailed description
Treating pediatric asthma has been in accordance with GINA guidelines by stepwise approach to adjust treatment for individual patient needs. However, most of the asthma controller medication nowadays is inhaled corticosteroids (ICS). Parents with steroid phobia may raise concern and fears about the potential systemic effects, leading to poor adherence to medication and worse control.
This study aims to evaluate the efficacy and safety of Chinese medicine (CM) formula combined with inhaled corticosteroid for the treatment of mild to moderate persistent asthma in children. Investigators focus on the following specific aims: Aim 1. To determine the efficacy of the CM formula (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) compared with placebo; Aim 2. To evaluate the effects of CM formula on quality of life in these patients with pediatric asthma; Aim 3. To investigate the safety of CM formula in these patients with pediatric asthma.
Eighty-six mild to moderate asthmatic children aged 4-11 years old with regular ICS usage will be randomized into two groups in this double-blind trial. Forty-three subjects will receive CM (CM group; Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and the other forty-three subjects will receive placebo (placebo group; 10% CM) for 12 weeks. The evaluation including pulmonary function test, IOS, FeNO, blood test, questionnaire and asthma diary card of both two groups will be conducted during the study period. The safety of CM formula use will be investigated by recording the adverse events and renal and liver function test as well.
This study will provide an objective data for evaluating the efficacy and safety o of Chinese medicine (CM) formula combined with inhaled corticosteroid in the treatment of asthmatic children. Through the combination of Chinese and western medicine, we expect to enhance the efficacy of asthma treatment, reduce acute exacerbation and tapper the dose of inhaled corticosteroids, leading to better quality of life.
- Conditions
- Childhood Asthma
- Being tested
- CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang), 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)
- Keywords
- childhood asthma, inhaled corticosteroids, Chinese medicine, Ma-Hsing-Kan-Shih-Tang, Liu-Jun-Zi-Tang
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)Drug
CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) for 12 weeks
10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)Drug
10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and 90% starch for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| CM group | Experimental | Not described Receives: Drug: CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) |
| placebo group | Placebo comparator | Not described Receives: Drug: 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Childhood Asthma Control Test (cACT)
cACT questionnaire is a tool to evaluate asthma symptoms
Measured: week 12
Secondary outcomes (9)
The change of FEV1/FVC (%) in spirometry
Spirometry can be used to easily evaluate pulmonary function for children older than 6 years old. Participants who are unable to perform forced expiratory maneuvers will use Impulse Oscillometry System (IOS) instead.
Measured: week 12
The change of CBC/DC
Blood test includes , total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function.
Measured: week 12
The change of total IgE
Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function.
Measured: week 12
The change of the ECP
Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function.
Measured: week 12
The change of IL-4
Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function.
Measured: week 12
The change of IL-5
Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function.
Measured: week 12
The change of IL-13
Blood test includes CBC/DC, total IgE, ECP and cytokines (IL-4/IL-5/IL-13) to evaluate the immunological function.
Measured: week 12
The change of scores of the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)
ITG-CASF is a tool to measure symptoms and disability in pediatric asthma patients
Measured: week 12
The change of scores of Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
PACQLQ is designed to measure the limitations and anxieties faced by caregivers of children with asthma.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start25 Sep 2021 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- More trials run by China Medical University 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chieh Wang, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066841
- Sponsor's protocol ID
- CMUH109-REC2-111
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Herbal Medicine Formula Combined With Inhaled Corticosteroids for the Treatment of Mild to Persistent Asthma in Children: a Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05066841
- Acronym / sponsor ID
- CMUH109-REC2-111
- Conditions
- Childhood Asthma
- Keywords
- childhood asthma, inhaled corticosteroids, Chinese medicine, Ma-Hsing-Kan-Shih-Tang, Liu-Jun-Zi-Tang
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 25 Sep 2021 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 4 Oct 2021 (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.
The purpose of study is to provide an objective data for evaluating the efficacy and safety of Chinese medicine (CM) formula combined with inhaled corticosteroid in the treatment of asthmatic children. Investigators will recruit eighty-six mild to moderate asthmatic children aged 4-11 years old with regular ICS usage and they will be randomized into two groups in this double-blind trial. Forty-three subjects will receive CM (CM group; Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and the other forty-three subjects will receive placebo (placebo group; 10% CM) for 12 weeks. Investigators will compare these two groups by questionnaires of Childhood Asthma Control Test (cACT), the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF), Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), the pulmonary function test and blood test including Complete Blood Count with Differential Count (CBC/DC), total IgE, Eosinophil Cationic Protein (ECP) and IL-4/IL-5/IL-13. Adverse events, renal and liver function test will be evaluated to investigate the safety of CM formula as well.
Detailed description
Treating pediatric asthma has been in accordance with GINA guidelines by stepwise approach to adjust treatment for individual patient needs. However, most of the asthma controller medication nowadays is inhaled corticosteroids (ICS). Parents with steroid phobia may raise concern and fears about the potential systemic effects, leading to poor adherence to medication and worse control.
This study aims to evaluate the efficacy and safety of Chinese medicine (CM) formula combined with inhaled corticosteroid for the treatment of mild to moderate persistent asthma in children. Investigators focus on the following specific aims: Aim 1. To determine the efficacy of the CM formula (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) compared with placebo; Aim 2. To evaluate the effects of CM formula on quality of life in these patients with pediatric asthma; Aim 3. To investigate the safety of CM formula in these patients with pediatric asthma.
Eighty-six mild to moderate asthmatic children aged 4-11 years old with regular ICS usage will be randomized into two groups in this double-blind trial. Forty-three subjects will receive CM (CM group; Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and the other forty-three subjects will receive placebo (placebo group; 10% CM) for 12 weeks. The evaluation including pulmonary function test, IOS, FeNO, blood test, questionnaire and asthma diary card of both two groups will be conducted during the study period. The safety of CM formula use will be investigated by recording the adverse events and renal and liver function test as well.
This study will provide an objective data for evaluating the efficacy and safety o of Chinese medicine (CM) formula combined with inhaled corticosteroid in the treatment of asthmatic children. Through the combination of Chinese and western medicine, we expect to enhance the efficacy of asthma treatment, reduce acute exacerbation and tapper the dose of inhaled corticosteroids, leading to better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM group | Experimental | Drug: CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) |
| placebo group | Placebo comparator | Drug: 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- aged 4-11 years old
- GINA (Global Initiative for Asthma) guideline belong to mild to moderate asthmatic children
- regular use low dose ICS+ LABA or medium dose ICS at least one month
Key exclusion criteria (3 listed)
- asthma with acute exacerbation or ever has used systemic steroids in recent one month
- psychiatric disease or behavior disorder
- ever has received Chinese herbal medicine or other traditional Chinese medicine treatment in recent two weeks
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 |
|---|---|---|
| CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) for 12 weeks | Drug | CM group |
| 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and 90% starch for 12 weeks | Drug | placebo group |
Primary outcome
The change of Childhood Asthma Control Test (cACT)
Time frame: week 12
cACT questionnaire is a tool to evaluate asthma symptoms
9 secondary outcomes
The change of FEV1/FVC (%) in spirometry
Time frame: week 12
The change of CBC/DC
Time frame: week 12
The change of total IgE
Time frame: week 12
The change of the ECP
Time frame: week 12
The change of IL-4
Time frame: week 12
The change of IL-5
Time frame: week 12
The change of IL-13
Time frame: week 12
The change of scores of the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)
Time frame: week 12
The change of scores of Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) in people with Childhood Asthma, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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 4 Oct 2021. 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 Taiwan. 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.
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 Chieh Wang (+886963619537, u9923035@cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Childhood Asthma Control Test (cACT) (time frame: week 12). 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 4 Oct 2021.