Clinical trial NCT02580942: Efficacy Study of Acupoint Sticking in Summer to Treat Asthma
Official title: Efficacy Study of Acupoint Sticking in Treating Winter Diseases in Summer to Treat Asthma of Kidney Yang Deficiency Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Health Bureau
First posted: 2015-10-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total score Change from Baseline of Asthma Control Test
timeFrame: Measured during the 6 week treatment period
Secondary outcomes:
measure: Cytokine levels of serum and induced sputum
timeFrame: Measured during the 6 week treatment period
measure: Lung function(FEV1, PVC, PEF)
timeFrame: Measured during the 6 week treatment period
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital Affiliated Shanghai University of TCM
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Zhenhui Lu, doctor
role: PRINCIPAL_INVESTIGATOR
References: