Traditional Chinese Medicine in Management of Childhood Asthma (TraCMAst)
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|ClinicalTrials.gov Identifier: NCT03645889|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : November 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asthma in Children||Other: PLTG Other: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised Controlled Trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Complementary Role of Herbal Traditional Chinese Medicine in Management of Mild to Moderate Childhood Asthma|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Paediatric Lung Tonic (PLTG)
Traditional Chinese Medicine (TCM) in granules dosage form to be dissolved for consumption.
A combination of 13 herbal granules
Placebo Comparator: PLTG Placebo
Starch granules with 10% TCM to mimic the colour, taste and smell of active TCM.
90% starch filler and 10% PLTG
- 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.
- Pulmonary Lung Function Change from Baseline at 3 months [ Time Frame: 3 months ]Improvement in pulmonary lung function will be assessed using spirometry test.
- Incidence of Treatment-Emergent Liver Associated Adverse Events [ Time Frame: 3 months ]Clinical biochemistry tests to assess liver functions
- Incidence of Treatment-Emergent Renal Associated Adverse Events [ Time Frame: 3 months ]Clinical biochemistry tests to assess renal functions
- Airway Inflammation Change from Baseline at 3 months [ Time Frame: 3 months ]Reduction in factional exhaled nitric oxide as an indicator for improvement in airway inflammation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645889
|Contact: Han Hui Cheong, PhDfirstname.lastname@example.org|
|Contact: Rupini Piragasam, BSc||+6563948246||Rupini.Piragasam@kkh.com.sg|
|KK Women's and Children's Hospital||Recruiting|
|Singapore, Singapore, 229899|
|Contact: Han Hui Cheong, PhD +6563943735 email@example.com|
|Contact: Rupini Piragasam, BSc +6563948246 Rupini.Piragasam@kkh.com.sg|
|Principal Investigator: Oon Hoe Teoh, MBBS|
|Sub-Investigator: Han Hui Cheong, PhD|
|Sub-Investigator: Oh Moh Chay, MBBS|
|Sub-Investigator: Wei Wei Tan, PharmD|
|Sub-Investigator: Biju Thomas, MBBS|
|Sub-Investigator: Anne EN Goh, MBBS|
|Sub-Investigator: Arun K Pugalenthi, MBBS|
|Sub-Investigator: Petrina PC Wong, MBBS|
|Sub-Investigator: Zai Ru Cheng, MBBS|
|Sub-Investigator: Yi Hua Tan, MBBS|
|Principal Investigator:||Oon Hoe Teoh, MBBS||KK Women's and Children's Hospital|