Efficacy Study of Acupoint Sticking in Summer to Treat Asthma

December 10, 2017 updated by: Shanghai University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Longhua Hospital Affiliated Shanghai University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
Other Names:
  • Medical Magnet Points For Aching Pain
Drug: Chinese herbal medicine
72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).
Other Names:
  • Warm Yang Applicator Party
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.
Drug: Chinese herbal medicine
72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).
Other Names:
  • Warm Yang Applicator Party
Device: 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.
Other Names:
  • Blank Points For Aching Pain

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

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Shanghai Municipal Health Bureau

Investigators

  • Principal Investigator: Zhenhui Lu, doctor, Shanghai University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

October 18, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 10, 2017

Last Verified

July 1, 2015

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)?

Undecided

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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