Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

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.

Study Overview

• Status: Unknown
• Conditions: Bronchial Asthma
• Intervention / Treatment: Drug: Ke Chuan Liu Wei Mixture; Drug: Ke Chuan Liu Wei Mixture placebo; Drug: Chuan Xiong Ping Chuan Mixture; Drug: Xie Wu Capsule; Drug: Chuan Xiong Ping Chuan Mixture placebo; Drug: Xie Wu Capsule placebo; Drug: Dan Ma Jia Tablet; Drug: Dan Ma Jia Tablet placebo; Drug: Zhi Chuan Capsule; Drug: Bu Shen Na Qi Granule; Drug: Zhi Chuan Capsule placebo; Drug: Bu Shen Na Qi Granule placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zifeng Ma, Master; Phone Number: 1307 +8602164385700; Email: mzf05@126.com
• Study Contact Backup: Name: Shaoyan Zhang, Doctor; Phone Number: 1307 +8602164385700; Email: 475205883@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Not yet recruiting
      • Kangjian Street Community Health Service Center
    • Shanghai, Shanghai, China, 200030
      • Not yet recruiting
      • Tianping Street Community Health Service Center
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Longhua Hospital Affiliated Shanghai University of TCM
    • Shanghai, Shanghai, China, 200030
      • Not yet recruiting
      • Fenglin Street Community Health Service Center
    • Shanghai, Shanghai, China, 201400
      • Not yet recruiting
      • Fengxian District Hospital of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients had positive bronchodilator reversibility test or positive bronchial challenge 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 Criteria:

• Smoking and continuous exposure to hazardous environment
• With fever, or severity of intermittent state, high degree of sustained, or with respiratory 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, gastroesophageal reflux, 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 the trial
• Patients with mental or neurological disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hanxiao treatment group; 36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.	Drug: Ke Chuan Liu Wei Mixture; Experience formula of famous traditional Chinese professor Yingen Wu; Other Names: Ke Chuan Liu Wei He Ji
Placebo Comparator: Hanxiao control group; 36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.	Drug: Ke Chuan Liu Wei Mixture placebo; Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture; Other Names: placebo
Experimental: Fengtanxiao treatment group; 36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.	Drug: Chuan Xiong Ping Chuan Mixture; Experience formula of famous traditional Chinese professor Changrong Shao; Other Names: Chuan Xiong Ping Chuan He Ji; Drug: Xie Wu Capsule; Experience formula of famous traditional Chinese professor Jianhua Hu; Other Names: Xie Wu Jiao Nang
Placebo Comparator: Fengtanxiao control group; 36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture placebo and Xie Wu Capsule placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.	Drug: Chuan Xiong Ping Chuan Mixture placebo; Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture; Other Names: placebo; Drug: Xie Wu Capsule placebo; Low dose combination for treating prescription of Xie Wu Capsule; Other Names: placebo
Experimental: Rexiao treatment group; 36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.	Drug: Dan Ma Jia Tablet; Experience formula of famous traditional Chinese professor Xiaopu Xu; Other Names: Dan Ma Jia Pian
Placebo Comparator: Rexiao control group; 36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.	Drug: Dan Ma Jia Tablet placebo; Low dose combination for treating prescription of Dan Ma Jia Tablet; Other Names: placebo
Experimental: Xuxiao treatment group; 36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule and Bu Shen Na Qi Granule oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.	Drug: Zhi Chuan Capsule; Experience formula of famous traditional Chinese professor Yingen Wu; Other Names: Zhi Chuan Jiao Nang; Drug: Bu Shen Na Qi Granule; Experience formula of famous traditional Chinese professor Changrong Shao; Other Names: Bu Shen Na Qi Ke Li
Placebo Comparator: Xuxiao control group; 36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule placebo and Bu Shen Na Qi Granule placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.	Drug: Zhi Chuan Capsule placebo; Low dose combination for treating prescription of Zhi Chuan Capsule; Other Names: placebo; Drug: Bu Shen Na Qi Granule placebo; Low dose combination for treating prescription of Bu Shen Na Qi Granule; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma control rate	Asthma control rate will be measured during study of asthma at exacerbation stage within 44 days and symptom-free months will be measured on remission period within 12 months	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function(FEV1, PVC, PEF)	Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months	up to 12 months
Measurement of the fractional concentration of exhaled nitric oxide	Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months	up to 12 months
Blood routine examination	Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months	up to 12 months
Cytokine levels of serum and induced sputum	Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months	up to 12 months
Liver function test	Measured Liver function	up to 12 months
Kidney function test	Measured Kidney function	up to 12 months
T cell classification	Measured T cell classification of PBMC	up to 12 months
Cytokine levels of induced sputum	Measured cytokine levels of induced sputum supernatant	up to 12 months

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Study Chair: Zhenhui Lu, Doctor, Longhua Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Bronchial Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: LH20161013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Through this study, to find the appropriate treatment of traditional Chinese medicine, then to further promote

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No