Efficacy Observation on Tian Jiu Therapy for Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Tian Jiu Therapy

• Registration Number: NCT05093062
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2016-08-31
• Study First Submitted: 2019-02-27
• Study Completion: 2021-08-31
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• History of Asthma

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

1. Episodic symptoms of airflow obstruction
2. Difficulty breathing
3. Chest tightness
4. Cough (worse at night)
5. Symptoms occurring or worsening at night, awakening the patient
6. 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
7. Wheezing
8. 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.

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Exclusion Criteria

1. Patients currently experiencing Acute asthma attack

2. Infants and child under thirteen years old 3.Pregnant women

3. Patients with

4. Fever and pharyngitis

5. Tuberculosis

6. Severe cardiac and pulmonary diseases

7. Diabetes Mellitus

8. Hypersensitive skin condition

9. Allergy to topical medication

10. Keloid

11. Bleeding disorders

12. Severe heart diseases and with pacemaker.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tian Jiu Therapy	Tian Jiu Therapy	-

Primary Outcome Measures

Name	Time	Method
The change in the frequency of asthma attack	baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment	The change in the frequency of asthma attack
The change in clinic visit	baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment	The change in clinic visit
The change in Quality of life	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)
The change in admission to hospital	baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment	The change in admission to hospital
The change in AE visit	baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment	The change in AE visit

Secondary Outcome Measures

Name	Time	Method
The change of Pulmonary Function (FEV1/FEC)	baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment	The change of Pulmonary Function (FEV1/FEC)
The change of Pulmonary Function (FEV1)	baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment	The change of Pulmonary Function (FEV1)