AsthmaNCT05093062
Efficacy Observation on Tian Jiu Therapy for Asthma
A study testing Tian Jiu Therapy in people with Asthma, run by The University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Tian Jiu Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 12Show fewer
- Diabetes Mellitus
- Hypersensitive skin condition
- Allergy to topical medication
- Keloid
- Bleeding disorders
- Severe heart diseases and with pacemaker.
About this study
Objectives:
To further evaluate the immediate, long-term and cumulative effects of Tian Jiu Therapy on asthma.
Read more
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.
- Conditions
- Asthma
- Being tested
- Tian Jiu Therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tian Jiu TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Tian Jiu Therapy | Other | Not described Receives: Other: Tian Jiu Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Quality of life
The change in Quality of life (SF-36 score)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Secondary outcomes (2)
The change of Pulmonary Function (FEV1)
The change of Pulmonary Function (FEV1)
Measured: 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)
Measured: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Apr 2015
- Primary completion31 Aug 2016
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093062
- Sponsor's protocol ID
- HHSRF 12133081
- Status last verified
- Nov 2022
- First submitted
- 27 Feb 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Observation on Tian Jiu Therapy for Asthma
- ClinicalTrials.gov ID
- NCT05093062
- Acronym / sponsor ID
- HHSRF 12133081
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tian Jiu Therapy | Other | Other: Tian Jiu Therapy |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- History of Asthma
- Episodic symptoms of airflow obstruction
- Difficulty breathing
- Chest tightness
- Cough (worse at night)
Key exclusion criteria (12 listed)
- Patients currently experiencing Acute asthma attack
- Infants and child under thirteen years old 3.Pregnant women
- 4. Patients with
- Fever and pharyngitis
- Tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tian Jiu Therapy | Other | Tian Jiu Therapy |
Primary outcome
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)
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
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
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
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
2 secondary outcomes
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/FEC)
Time frame: baseline, change from baseline at 1-2th week; change from baseline at 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tian Jiu Therapy in people with Asthma, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.