Clinical Study on Treatment of Chronic Persistent Bronchial Asthma

May 24, 2023 updated by: Shanghai University of Traditional Chinese Medicine

Clinical Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine

Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of asthma in China is high and the rate of control is low. 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 further optimize the prescription of Chinese medicine treatment.

In this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program for 28 days.Participants will undergo a physical examination, lung function, blood and sputum collection.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Zifeng Ma, Doctor
  • Phone Number: 1307 +8621-64385700
  • Email: mzf05@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Fenglin Street Community Health Service Center
        • Contact:
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Kangjian Street Community Health Service Center
        • Contact:
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Tianping Street Community Health Service Center
        • Contact:
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Longhua Hospital Affiliated Shanghai University of TCM
        • Contact:
          • Zifeng Ma, Master
          • Phone Number: +8618817338863
          • Email: mzf05@126.com
      • Shanghai, Shanghai, China, 201400
        • Recruiting
        • Fengxian District Hospital of TCM
        • Contact:

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

Description

Inclusion Criteria:

  • Patient diagnosed with chronic persistent asthma
  • Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
  • Conform to the predetermined 2 TCM Syndrome Types
  • Patients who have given written informed consent

Exclusion Criteria:

  • Smoking and continuous exposure to hazardous environment
  • With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
  • Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
  • Patients who are allergic to therapeutic medicine

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hanxiao treatment group
80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
Drug: Ke Chuan Liu Wei Granule
Traditional Chinese Medicine
Other Names:
  • KCLW Granule
Sham Comparator: Hanxiao control group
80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
Other: Ke Chuan Liu Wei Granule placebo
Placebo
Other Names:
  • Placebo
Experimental: Xuxiao treatment group
80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
Drug: Yang He Ping Chuan Granule
Traditional Chinese Medicine
Other Names:
  • YHPC Granule
Sham Comparator: Xuxiao control group
80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
Other: Yang He Ping Chuan Granule placebo
Placebo
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma control rate change
Time Frame: up to 4 weeks
Measured the change from Baseline of asthma control rate
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function(FEV1, PEF)
Time Frame: Up to 4 weeks
Measured routine pulmonary ventilation function test
Up to 4 weeks
FeNO
Time Frame: Up to 4 weeks
The fractional concentration of exhaled nitric oxide
Up to 4 weeks
Blood routine examination
Time Frame: Up to 4 weeks
Hematological routine examination
Up to 4 weeks
Liver function test
Time Frame: Up to 4 weeks
Simple liver function test
Up to 4 weeks
Cytokine levels of induced sputum
Time Frame: Up to 4 weeks
Measured cytokine levels of induced sputum supernatant
Up to 4 weeks
Kidney function test
Time Frame: Up to 4 weeks
Simple kidney function test
Up to 4 weeks

Collaborators and Investigators

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

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

Longhua Hospital

Investigators

  • Principal Investigator: Huiyong Zhang, Director, tcmdoctorzhang@163.com

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)

February 1, 2018

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017LCSY347

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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