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Efficacy Study of Acupoint Sticking in Summer to Treat Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magnetic stickers
Sham magnetic stickers
Chinese herbal medicine
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Longhua Hospital Affiliated Shanghai University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupoint sticking therapy group

Sham sticking therapy group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Total score Change from Baseline of Asthma Control Test

Secondary Outcome Measures

Cytokine levels of serum and induced sputum
Lung function(FEV1, PVC, PEF)

Full Information

First Posted
July 30, 2015
Last Updated
December 10, 2017
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Municipal Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT02580942
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai Municipal Health Bureau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupoint sticking therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham sticking therapy group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic stickers
Other Intervention Name(s)
Medical Magnet Points For Aching Pain
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham magnetic stickers
Other Intervention Name(s)
Blank Points For Aching Pain
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Chinese herbal medicine
Other Intervention Name(s)
Warm Yang Applicator Party
Intervention Description
72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).
Primary Outcome Measure Information:
Title
Total score Change from Baseline of Asthma Control Test
Time Frame
Measured during the 6 week treatment period
Secondary Outcome Measure Information:
Title
Cytokine levels of serum and induced sputum
Time Frame
Measured during the 6 week treatment period
Title
Lung function(FEV1, PVC, PEF)
Time Frame
Measured during the 6 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenhui Lu, doctor
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Longhua Hospital Affiliated Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy Study of Acupoint Sticking in Summer to Treat Asthma

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