Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

Last updated: February 24, 2020
Sponsor: Shanghai University of Traditional Chinese Medicine
Overall Status: Active - Recruiting

Phase

2

Condition

Allergies & Asthma

Asthma

Treatment

N/A

Clinical Study ID

NCT02937207
LH20161013
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to promote the application in community hospitals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients had positive bronchodilator reversibility test or positive bronchialchallenge test or more than 50 parts per billion of FENO before

  • Number of months without control between 1 and 3 months last year

  • The course of asthma was more than 10 years and less than 30 years

  • Conform to the predetermined 4 TCM Syndrome Types

  • Patients who have given written informed consent

Exclusion

Exclusion Criteria:

  • Smoking and continuous exposure to hazardous environment

  • With fever, or severity of intermittent state, high degree of sustained, or withrespiratory failure, etc.

  • Long term inhaled corticosteroids (more than 5 years) prior to study entry

  • Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema,pulmonary heart disease, pneumonia, lung cancer and other lung diseases

  • Rheumatic immune disease, diabetes, hyperthyroidism, menopause, gastroesophagealreflux, arrhythmia and other complications of the disease

  • Heart, liver, kidney and other organ dysfunction

  • Accompanied by other diseases of long-term use of glucocorticoids, anti allergy drugs,mental or neurological drugs or traditional Chinese Medicine

  • Patients who are allergic to therapeutic medicine

  • Female patients in lactation period, pregnancy or planning to get pregnant during thetrial

  • Patients with mental or neurological disorders

Study Design

Total Participants: 288
Study Start date:
July 30, 2017
Estimated Completion Date:
December 31, 2021

Study Description

Asthma is a serious global health problem and has increasing prevalence in many countries.Although asthma symptoms can be controlled by drug treatment to a large extent, there is still inadequate.Traditional Chinese medicine has a long history of treating asthma, and has a good clinical curative effect.The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to promote the application in community hospitals. This could constitute a significant advance in asthma management.

In this study, the investigators recruited patients with asthma exacerbation and remission stage, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program.Participants will undergo a physical examination, lung function, blood and sputum collection.

Exacerbation group belongs to cold type of asthma patients will take Ke Chuan Liu Wei Mixture, wind phlegm type of asthma patients will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule,and hot type of asthma patients will take Dan Ma Jia Tablet for 14 days treatment, while the 3 control groups were given 3 corresponding placebo treatment for a total of 14 days.

Remission phase of Yang deficiency patients in treatment group will take Zhi Chuan Capsule and Bu Shen Na Qi Granule, and in control group received a placebo treatment for a total of 60 days.

Study visits will occur for 7 days of exacerbation group and 1 year for remission group. Questionnaires to assess asthma control will be completed during study of asthma at exacerbation stage within 44 days and on remission period within 12 months.

Connect with a study center

  • Fenglin Street Community Health Service Center

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Fengxian District Hospital of TCM

    Shanghai, Shanghai 201400
    China

    Site Not Available

  • Kangjian Street Community Health Service Center

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Longhua Hospital Affiliated Shanghai University of TCM

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Tianping Street Community Health Service Center

    Shanghai, Shanghai 200030
    China

    Site Not Available

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