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Completed

NCT Number: NCT05093062

Efficacy Observation on Tian Jiu Therapy for Asthma

Objectives:

To further evaluate the immediate, long-term and cumulative effects of Tian Jiu Therapy on asthma.

Hypothesis to be tested:

The efficacy of Tian Jiu Therapy on asthma is also long-term and will be accumulated.

Design and Subjects:

Recruiting 167 asthma participants who received Tian Jiu Therapy under the primary study of HKCTR-1128. All subjects should be above age 13 and receive the same Tian Jiu Therapy, 3 times per year from 2013 to 2015. A one-year follow-up after the last Tian Jiu treatment will be conducted.

Study instruments:

Modern USB PC-based Spirometer and Fingertip Pulse Oximeter.

Interventions:

Plastering some stimulating Chinese herbal cubes on certain acupoints in the three hottest days of each year, for three consecutive years.

Main outcome measures:

Pulmonary Function Test, Blood Oxygen Test, Quality of Life and Standardized Questionnaire on asthma attack and symptoms will be administered before treatment, after treatment of each year and one-year follow-up after the last treatment.

Data analysis:

All the parameters will be analyzed, the physical improvement (Cured, Remarkably effective, Effective and Ineffective) will be recorded, and the differences in different treatment courses will be investigated and compared with previous data obtained in the primary study of HKCTR-1128 by using standard statistical analysis.

Expected results:

The effect of Tian Jiu Therapy on Asthma is not only immediate but also long-term and will be gradually accumulated.

The Tian Jiu Therapy will acquire better efficacy on asthma if this treatment was conducted more years continuously.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of Asthma

Diagnostic Criteria of Asthma according to U.S.DHHS(2007):

  • Episodic symptoms of airflow obstruction
  • Difficulty breathing
  • Chest tightness
  • Cough (worse at night)
  • Symptoms occurring or worsening at night, awakening the patient
  • Symptoms occurring or worsening with exercise, viral infections, changes in weather, strong emotions, or mens; or in the presence of animals, dust mites, mold, smoke, pollen, or chemicals
  • Wheezing
  • Airflow obstruction at least partially reversible Medically stable and acute medical care does not require. E.g. intensive monitoring, invasive ventilation, haemoid-dialysis, cardiac support.

Exclusion criteria

  • Patients currently experiencing Acute asthma attack
  • Infants and child under thirteen years old 3.Pregnant women
  • Patients with
  • Fever and pharyngitis
  • Tuberculosis
  • Severe cardiac and pulmonary diseases
  • Diabetes Mellitus
  • Hypersensitive skin condition
  • Allergy to topical medication
  • Keloid
  • Bleeding disorders
  • Severe heart diseases and with pacemaker.

Treatment and study plan

Tian Jiu Therapy

Other

Primary outcomes

  1. The change in Quality of life

    Time frame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment

    The change in Quality of life (SF-36 score)

  2. The change in the frequency of asthma attack

    Time frame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment

    The change in the frequency of asthma attack

  3. The change in admission to hospital

    Time frame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment

    The change in admission to hospital

  4. The change in AE visit

    Time frame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment

    The change in AE visit

  5. The change in clinic visit

    Time frame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment

    The change in clinic visit

Secondary outcomes

  1. The change of Pulmonary Function (FEV1)

    Time frame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment

    The change of Pulmonary Function (FEV1)

  2. The change of Pulmonary Function (FEV1/FEC)

    Time frame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment

    The change of Pulmonary Function (FEV1/FEC)

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2021
First posted
Oct 26, 2021
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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