Efficacy Study of Acupoint Sticking in Summer to Treat Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy Study of Acupoint Sticking in Treating Winter Diseases in Summer to Treat Asthma of Kidney Yang Deficiency Type

Conditions
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Asthma

Intervention / Treatment
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* Device: Magnetic stickers
* Device: Sham magnetic stickers
* Drug: Chinese herbal medicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupoint sticking therapy group<br>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. | Device: Magnetic stickers<br>* 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.<br>* Other names: Medical Magnet Points For Aching Pain;Drug: Chinese herbal medicine<br>* 72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).<br>* Other names: Warm Yang Applicator Party;|
| Sham Comparator: Sham sticking therapy group<br>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. | Device: Sham magnetic stickers<br>* 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.<br>* Other names: Blank Points For Aching Pain;Drug: Chinese herbal medicine<br>* 72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).<br>* Other names: Warm Yang Applicator Party;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score Change from Baseline of Asthma Control Test |  | Measured during the 6 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine levels of serum and induced sputum |  | Measured during the 6 week treatment period | 
| Lung function(FEV1, PVC, PEF) |  | Measured during the 6 week treatment period |