Traditional Chinese Medicine in Management of Childhood Asthma

NCT03645889 | Unknown Phase 2 DMC

• 1 other identifier: 2017/3129
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Asthma in Children

Keywords

Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pulmonary Lung Function Change from Baseline at 3 months

  3 months

• Incidence of Treatment-Emergent Liver Associated Adverse Events

  3 months

• Incidence of Treatment-Emergent Renal Associated Adverse Events

  3 months

• Airway Inflammation Change from Baseline at 3 months

  3 months

Study Arms (2)

Paediatric Lung Tonic (PLTG)

EXPERIMENTAL

Traditional Chinese Medicine (TCM) in granules dosage form to be dissolved for consumption.

Other: PLTG

PLTG Placebo

PLACEBO COMPARATOR

Starch granules with 10% TCM to mimic the colour, taste and smell of active TCM.

Other: Placebo

Interventions

PLTG OTHER

A combination of 13 herbal granules

Paediatric Lung Tonic (PLTG)

Placebo OTHER

90% starch filler and 10% PLTG

PLTG Placebo

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Singapore Thong Chai Medical Institution: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

MeSH Terms

Interventions

1,2-dioleoyl-3-(9-(3-perylenoyl)nonanoyl)glycerol

Study Officials

• Oon Hoe Teoh, MBBS

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Hui Cheong, PhD

CONTACT

+6563943735; cheong.han.hui@kkh.com.sg

Rupini Piragasam, BSc

CONTACT

+6563948246; Rupini.Piragasam@kkh.com.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: August 24, 2018
• Study Start: October 15, 2018
• Primary Completion: March 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 26, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)