Efficacy Study of Acupoint Sticking in Summer to Treat Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580942
• Other study ID #: 13401905400
• Status: Completed
• Phase: N/A
• First received: July 30, 2015
• Last updated: December 10, 2017
• Start date: July 2015
• Est. completion date: September 2017

Study information

• Verified date: July 2015
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Magnetic stickers
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 stickers
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.

Drug:
• Chinese herbal medicine
72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).

Locations

Country	Name	City	State
China	Longhua Hospital Affiliated Shanghai University of TCM	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Shanghai Municipal Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score Change from Baseline of Asthma Control Test		Measured during the 6 week treatment period
Secondary	Cytokine levels of serum and induced sputum		Measured during the 6 week treatment period
Secondary	Lung function(FEV1, PVC, PEF)		Measured during the 6 week treatment period