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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 : August 24, 2018
Sponsor:
Collaborator:
Singapore Thong Chai Medical Institution
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Brief 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. According to 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, 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.

Condition or disease Intervention/treatment Phase
Asthma in Children Other: PLTG Other: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Complementary Role of Herbal Traditional Chinese Medicine in Management of Mild to Moderate Childhood Asthma
Estimated Study Start Date : August 16, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Paediatric Lung Tonic (PLTG)
Traditional Chinese Medicine (TCM) in granules dosage form to be dissolved for consumption.
Other: PLTG

A combination of 13 herbal granules:

  1. Radix Codonopsis
  2. Rhizoma Atractylodis Macrocephalae
  3. Sclerotium Poriae Cocos
  4. Radix Glycyrrhizae Preparata
  5. Radix Astragali
  6. Radix Saposhnikoviae
  7. Fructus Schisandrae
  8. Flos Magnoliae
  9. Exocarpium Citri Rubrum
  10. Rhizoma Dioscoreae
  11. Mass Fermentata
  12. Cortex Mori
  13. Radix Ophiopogonis

Placebo Comparator: PLTG Placebo
Starch granules with 10% TCM to mimic the colour, taste and smell of active TCM.
Other: Placebo
90% starch filler and 10% PLTG




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pulmonary Lung Function Change from Baseline at 3 months [ Time Frame: 3 months ]
    Improvement in pulmonary lung function will be assessed using spirometry test.

  2. Incidence of Treatment-Emergent Liver Associated Adverse Events [ Time Frame: 3 months ]
    Clinical biochemistry tests to assess liver functions

  3. Incidence of Treatment-Emergent Renal Associated Adverse Events [ Time Frame: 3 months ]
    Clinical biochemistry tests to assess renal functions

  4. 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.



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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have asthma which is partly controlled based on Global Initiative for Asthma (GINA) asthma control classification guideline and has Asthma Control Test (ACT) score ≥18 at point of recruitment.
  • Currently using fluticasone as the only regular inhaled corticosteroid therapy for asthma control with fluticasone dosage ≤ 200mcg/day for at least past 3 months.
  • Able to perform pulmonary function test with the following baseline results:

    • Forced Expiratory Volume at 1 sec (FEV1) Bronchodilator response >=12% change and/or
    • Forced Expiratory Flow at 25-75% of pulmonary volume (FEF25-75) >=30%
  • Fulfil the TCM criteria of "lung-spleen qi deficiency " type of asthma

Exclusion Criteria:

  • 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 or other forms of complementary alternative medicines.
  • Baseline spirometry results for FEV1 <70%.
  • Record of hospital admission for conditions related to asthma or other respiratory conditions in the last 3 months.
  • Had changes in conventional treatment regimen for asthma management, inclusive of dosage in the last 3 months.
  • Pregnant or lactation
  • Known allergic reactions to food such as peanut, seafood, egg and milk

Information from the National Library of Medicine

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


Contacts
Contact: Han Hui Cheong, PhD +6563943735 cheong.han.hui@kkh.com.sg
Contact: Rupini Piragasam, BSc +6563948246 Rupini.Piragasam@kkh.com.sg

Locations
Singapore
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: Han Hui Cheong, PhD    +6563943735    cheong.han.hui@kkh.com.sg   
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         
Sponsors and Collaborators
KK Women's and Children's Hospital
Singapore Thong Chai Medical Institution
Investigators
Principal Investigator: Oon Hoe Teoh, MBBS KK Women's and Children's Hospital

Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT03645889     History of Changes
Other Study ID Numbers: 2017/3129
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KK Women's and Children's Hospital:
Traditional Chinese Medicine

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases