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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Tian Jiu Therapy

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

1. Patients currently experiencing Acute asthma attack
2. Infants and child under thirteen years old 3.Pregnant women

4. Patients with

1. Fever and pharyngitis
2. Tuberculosis
3. Severe cardiac and pulmonary diseases
4. Diabetes Mellitus
5. Hypersensitive skin condition
6. Allergy to topical medication
7. Keloid
8. Bleeding disorders
9. Severe heart diseases and with pacemaker.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Tian Jiu Therapy	Other: Tian Jiu Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Quality of life	The change in Quality of life (SF-36 score)	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 the frequency of asthma attack	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 admission to hospital	baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
The change in AE visit	The change in AE 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 clinic visit	baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• 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: HHSRF 12133081

Drug and device information, study documents

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