Traditional Chinese Medicine in Management of Childhood Asthma (TraCMAst)

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.

Study Overview

• Status: Unknown
• Conditions: Asthma in Children
• Intervention / Treatment: Other: PLTG; Other: Placebo

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
• Enrollment (Anticipated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Han Hui Cheong, PhD; Phone Number: +6563943735; Email: cheong.han.hui@kkh.com.sg
• Study Contact Backup: Name: Rupini Piragasam, BSc; Phone Number: +6563948246; Email: Rupini.Piragasam@kkh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • Recruiting
    • KK Women's and Children's Hospital
    • Contact: Han Hui Cheong, PhD; Phone Number: +6563943735; Email: cheong.han.hui@kkh.com.sg
    • Contact: Rupini Piragasam, BSc; Phone Number: +6563948246; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≥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

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
• Pregnant or lactation
• Known allergic reactions to food such as peanut, seafood, egg and milk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Lung Function Change from Baseline at 3 months	Improvement in pulmonary lung function will be assessed using spirometry test.	3 months
Incidence of Treatment-Emergent Liver Associated Adverse Events	Clinical biochemistry tests to assess liver functions	3 months
Incidence of Treatment-Emergent Renal Associated Adverse Events	Clinical biochemistry tests to assess renal functions	3 months
Airway Inflammation Change from Baseline at 3 months	Reduction in factional exhaled nitric oxide as an indicator for improvement in airway inflammation.	3 months

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: Singapore Thong Chai Medical Institution
• Investigators: Principal Investigator: Oon Hoe Teoh, MBBS, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2017/3129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No