- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02580942
Efficacy Study of Acupoint Sticking in Summer to Treat Asthma
Efficacy Study of Acupoint Sticking in Treating Winter Diseases in Summer to Treat Asthma of Kidney Yang Deficiency Type
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200032
- Longhua Hospital Affiliated Shanghai University of TCM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with mild-to-moderate remission phase of asthma
- Patients who have given written informed consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupoint sticking therapy group
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.
|
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.
Other Names:
72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).
Other Names:
|
Sham Comparator: Sham sticking therapy group
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.
|
72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total score Change from Baseline of Asthma Control Test
Time Frame: Measured during the 6 week treatment period
|
Measured during the 6 week treatment period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cytokine levels of serum and induced sputum
Time Frame: Measured during the 6 week treatment period
|
Measured during the 6 week treatment period
|
Lung function(FEV1, PVC, PEF)
Time Frame: Measured during the 6 week treatment period
|
Measured during the 6 week treatment period
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Zhenhui Lu, doctor, Shanghai University of Traditional Chinese Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13401905400
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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