Clinical trial NCT05093062: Efficacy Observation on Tian Jiu Therapy for Asthma
Official title: Efficacy Observation on Tian Jiu Therapy for Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 136
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change in Quality of life
timeFrame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
measure: The change in the frequency of asthma attack
timeFrame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
measure: The change in admission to hospital
timeFrame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
measure: The change in AE visit
timeFrame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
measure: The change in clinic visit
timeFrame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Secondary outcomes:
measure: The change of Pulmonary Function (FEV1)
timeFrame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
measure: The change of Pulmonary Function (FEV1/FEC)
timeFrame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Other outcomes:
Locations:
Study officials:
References: