AsthmaNCT02580942
Efficacy Study of Acupoint Sticking in Summer to Treat Asthma
A study testing Magnetic stickers and Chinese herbal medicine in people with Asthma, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases in Summer is effective in the treatment of chronic asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Magnetic stickers and Chinese herbal medicine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Sep 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with mild-to-moderate remission phase of asthma
- Patients who have given written informed consent
Who cannot join
- Participation in another clinical trial 1 month prior to study entry
- Participation received acupoint sticking of winter disease cured in summer
- Use of corticosteroids 4 weeks prior to study entry
- Patients who are allergic to therapeutic medicine
- Female patients in lactation period, pregnancy or planning to get pregnant during the trial
- Patients with severe primary diseases such as cancer, cardiovascular system, digestive system, kidney and hematopoietic system diseases
- Patients with mental illness, acrasia
Trial locations and contacts
1 site in 1 country.
China1 site
Longhua Hospital Affiliated Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Efficacy Study of Acupoint Sticking in Treating Winter Diseases in Summer to Treat Asthma of Kidney Yang Deficiency Type
The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases in Summer is effective in the treatment of chronic asthma.
Read the detailed description
Asthma is a common chronic disease with an estimated 300 million worldwide. Treating Winter Diseases in Summer of traditional Chinese medicine treatment of asthma has a long history. But there are less related clinical trials. The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases in Summer is effective in the treatment of chronic asthma.
After screening period, participants will undergo a physical examination, lung function, blood and induced sputum collection while being randomly assigned to one of the following 2 groups for 6 weeks during summer dog days of treatment:
Group A will receive acupoint sticking treatment of Chinese herbal medicine and magnetic stickers once every two days； Group B will receive acupoint sticking treatment of Chinese herbal medicine and sham magnetic stickers once every two days.
Questionnaires to assess asthma control and quality of life will be completed. A physical examination, blood collection, and induced sputum collection will occur at selected visits.
- Conditions
- Asthma
- Being tested
- Magnetic stickers, Sham magnetic stickers, Chinese herbal medicine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic stickersDevice
Also called Medical Magnet Points For Aching Pain
36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.
Sham magnetic stickersDevice
Also called Blank Points For Aching Pain
36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and sham magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.
Chinese herbal medicineDrug
Also called Warm Yang Applicator Party
72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).
| Study group | Role | What they receive |
|---|---|---|
| Acupoint sticking therapy group | Experimental | 36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks. Receives: Device: Magnetic stickers; Drug: Chinese herbal medicine |
| Sham sticking therapy group | Sham comparator | 36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and sham magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks. Receives: Device: Sham magnetic stickers; Drug: Chinese herbal medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score Change from Baseline of Asthma Control Test
Measured: Measured during the 6 week treatment period
Secondary outcomes (2)
Cytokine levels of serum and induced sputum
Measured: Measured during the 6 week treatment period
Lung function(FEV1, PVC, PEF)
Measured: Measured during the 6 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2017
- Study completionSep 2017
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Health Bureau
- Responsible party
- Sponsor
- Investigators
- Zhenhui Lu, doctor, Principal investigator, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580942
- Sponsor's protocol ID
- 13401905400
- Status last verified
- Jul 2015
- First submitted
- 30 Jul 2015
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Acupoint Sticking in Treating Winter Diseases in Summer to Treat Asthma of Kidney Yang Deficiency Type
- ClinicalTrials.gov ID
- NCT02580942
- Acronym / sponsor ID
- 13401905400
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Municipal Health Bureau
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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.
The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases in Summer is effective in the treatment of chronic asthma.
Detailed description
Asthma is a common chronic disease with an estimated 300 million worldwide. Treating Winter Diseases in Summer of traditional Chinese medicine treatment of asthma has a long history. But there are less related clinical trials. The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases in Summer is effective in the treatment of chronic asthma.
After screening period, participants will undergo a physical examination, lung function, blood and induced sputum collection while being randomly assigned to one of the following 2 groups for 6 weeks during summer dog days of treatment:
Group A will receive acupoint sticking treatment of Chinese herbal medicine and magnetic stickers once every two days； Group B will receive acupoint sticking treatment of Chinese herbal medicine and sham magnetic stickers once every two days.
Questionnaires to assess asthma control and quality of life will be completed. A physical examination, blood collection, and induced sputum collection will occur at selected visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupoint sticking therapy group | Experimental | Device: Magnetic stickers, Drug: Chinese herbal medicine36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks. |
| Sham sticking therapy group | Sham comparator | Device: Sham magnetic stickers, Drug: Chinese herbal medicine36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and sham magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with mild-to-moderate remission phase of asthma
- Patients who have given written informed consent
Key exclusion criteria (7 listed)
- Participation in another clinical trial 1 month prior to study entry
- Participation received acupoint sticking of winter disease cured in summer
- Use of corticosteroids 4 weeks prior to study entry
- Patients who are allergic to therapeutic medicine
- Female patients in lactation period, pregnancy or planning to get pregnant during the trial
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 |
|---|---|---|
| Magnetic stickersAlso: Medical Magnet Points For Aching Pain36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks. | Device | Acupoint sticking therapy group |
| Sham magnetic stickersAlso: Blank Points For Aching Pain36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and sham magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks. | Device | Sham sticking therapy group |
| Chinese herbal medicineAlso: Warm Yang Applicator Party72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22). | Drug | Acupoint sticking therapy group, Sham sticking therapy group |
Primary outcome
Total score Change from Baseline of Asthma Control Test
Time frame: Measured during the 6 week treatment period
2 secondary outcomes
Cytokine levels of serum and induced sputum
Time frame: Measured during the 6 week treatment period
Lung function(FEV1, PVC, PEF)
Time frame: Measured during the 6 week treatment period
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 12 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
Zhenhui Lu, doctor principal investigator
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic stickers and Chinese herbal medicine in people with Asthma, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 2 inclusion and 7 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 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Total score Change from Baseline of Asthma Control Test (time frame: Measured during the 6 week treatment period). 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 12 Dec 2017.