Efficacy Observation on Tian Jiu Therapy for Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tian Jiu Therapy
Sponsored by

About this trial
This is an interventional prevention trial for Asthma
Eligibility Criteria
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
4. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Tian Jiu Therapy
Arm Description
Outcomes
Primary Outcome Measures
The change in Quality of life
The change in Quality of life (SF-36 score)
The change in the frequency of asthma attack
The change in the frequency of asthma attack
The change in admission to hospital
The change in admission to hospital
The change in AE visit
The change in AE visit
The change in clinic visit
The change in clinic visit
Secondary Outcome Measures
The change of Pulmonary Function (FEV1)
The change of Pulmonary Function (FEV1)
The change of Pulmonary Function (FEV1/FEC)
The change of Pulmonary Function (FEV1/FEC)
Full Information
NCT ID
NCT05093062
First Posted
February 27, 2019
Last Updated
November 1, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05093062
Brief Title
Efficacy Observation on Tian Jiu Therapy for Asthma
Official Title
Efficacy Observation on Tian Jiu Therapy for Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tian Jiu Therapy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Tian Jiu Therapy
Primary Outcome Measure Information:
Title
The change in Quality of life
Description
The change in Quality of life (SF-36 score)
Time Frame
baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Title
The change in the frequency of asthma attack
Description
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
Title
The change in admission to hospital
Description
The change in admission to hospital
Time Frame
baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Title
The change in AE visit
Description
The change in AE visit
Time Frame
baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Title
The change in clinic visit
Description
The change in clinic visit
Time Frame
baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Secondary Outcome Measure Information:
Title
The change of Pulmonary Function (FEV1)
Description
The change of Pulmonary Function (FEV1)
Time Frame
baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Title
The change of Pulmonary Function (FEV1/FEC)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
4. 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.
12. IPD Sharing Statement
Learn more about this trial
Efficacy Observation on Tian Jiu Therapy for Asthma
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