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Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

Primary Purpose

Bronchial Asthma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ke Chuan Liu Wei Mixture
Chuan Xiong Ping Chuan Mixture
Xie Wu Capsule
Dan Ma Jia Tablet
Zhi Chuan Capsule
Bu Shen Na Qi Granule
Ke Chuan Liu Wei Mixture placebo
Chuan Xiong Ping Chuan Mixture placebo
Xie Wu Capsule placebo
Dan Ma Jia Tablet placebo
Zhi Chuan Capsule placebo
Bu Shen Na Qi Granule placebo
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 Bronchial Asthma focused on measuring Bronchial Asthma, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fenglin Street Community Health Service Center
  • Kangjian Street Community Health Service Center
  • Tianping Street Community Health Service Center
  • Longhua Hospital Affiliated Shanghai University of TCMRecruiting
  • Fengxian District Hospital of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Hanxiao treatment group

Hanxiao control group

Fengtanxiao treatment group

Fengtanxiao control group

Rexiao treatment group

Rexiao control group

Xuxiao treatment group

Xuxiao control group

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Lung function(FEV1, PVC, PEF)
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 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
Blood routine examination
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 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
Liver function test
Measured Liver function
Kidney function test
Measured Kidney function
T cell classification
Measured T cell classification of PBMC
Cytokine levels of induced sputum
Measured cytokine levels of induced sputum supernatant

Full Information

First Posted
October 14, 2016
Last Updated
February 24, 2020
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02937207
Brief Title
Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine
Official Title
Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
Bronchial Asthma, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hanxiao treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Hanxiao control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Fengtanxiao treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Fengtanxiao control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Rexiao treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Rexiao control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Xuxiao treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Xuxiao control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ke Chuan Liu Wei Mixture
Other Intervention Name(s)
Ke Chuan Liu Wei He Ji
Intervention Description
Experience formula of famous traditional Chinese professor Yingen Wu
Intervention Type
Drug
Intervention Name(s)
Chuan Xiong Ping Chuan Mixture
Other Intervention Name(s)
Chuan Xiong Ping Chuan He Ji
Intervention Description
Experience formula of famous traditional Chinese professor Changrong Shao
Intervention Type
Drug
Intervention Name(s)
Xie Wu Capsule
Other Intervention Name(s)
Xie Wu Jiao Nang
Intervention Description
Experience formula of famous traditional Chinese professor Jianhua Hu
Intervention Type
Drug
Intervention Name(s)
Dan Ma Jia Tablet
Other Intervention Name(s)
Dan Ma Jia Pian
Intervention Description
Experience formula of famous traditional Chinese professor Xiaopu Xu
Intervention Type
Drug
Intervention Name(s)
Zhi Chuan Capsule
Other Intervention Name(s)
Zhi Chuan Jiao Nang
Intervention Description
Experience formula of famous traditional Chinese professor Yingen Wu
Intervention Type
Drug
Intervention Name(s)
Bu Shen Na Qi Granule
Other Intervention Name(s)
Bu Shen Na Qi Ke Li
Intervention Description
Experience formula of famous traditional Chinese professor Changrong Shao
Intervention Type
Drug
Intervention Name(s)
Ke Chuan Liu Wei Mixture placebo
Other Intervention Name(s)
placebo
Intervention Description
Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
Intervention Type
Drug
Intervention Name(s)
Chuan Xiong Ping Chuan Mixture placebo
Other Intervention Name(s)
placebo
Intervention Description
Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
Intervention Type
Drug
Intervention Name(s)
Xie Wu Capsule placebo
Other Intervention Name(s)
placebo
Intervention Description
Low dose combination for treating prescription of Xie Wu Capsule
Intervention Type
Drug
Intervention Name(s)
Dan Ma Jia Tablet placebo
Other Intervention Name(s)
placebo
Intervention Description
Low dose combination for treating prescription of Dan Ma Jia Tablet
Intervention Type
Drug
Intervention Name(s)
Zhi Chuan Capsule placebo
Other Intervention Name(s)
placebo
Intervention Description
Low dose combination for treating prescription of Zhi Chuan Capsule
Intervention Type
Drug
Intervention Name(s)
Bu Shen Na Qi Granule placebo
Other Intervention Name(s)
placebo
Intervention Description
Low dose combination for treating prescription of Bu Shen Na Qi Granule
Primary Outcome Measure Information:
Title
Asthma control rate
Description
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
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Lung function(FEV1, PVC, PEF)
Description
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months
Time Frame
up to 12 months
Title
Measurement of the fractional concentration of exhaled nitric oxide
Description
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months
Time Frame
up to 12 months
Title
Blood routine examination
Description
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months
Time Frame
up to 12 months
Title
Cytokine levels of serum and induced sputum
Description
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months
Time Frame
up to 12 months
Title
Liver function test
Description
Measured Liver function
Time Frame
up to 12 months
Title
Kidney function test
Description
Measured Kidney function
Time Frame
up to 12 months
Title
T cell classification
Description
Measured T cell classification of PBMC
Time Frame
up to 12 months
Title
Cytokine levels of induced sputum
Description
Measured cytokine levels of induced sputum supernatant
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zifeng Ma, Master
Phone
+8602164385700
Ext
1307
Email
mzf05@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shaoyan Zhang, Doctor
Phone
+8602164385700
Ext
1307
Email
475205883@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenhui Lu, Doctor
Organizational Affiliation
Longhua Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fenglin Street Community Health Service Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuntao Yi, Master
Phone
+8618817338803
Email
yichuntao@126.com
Facility Name
Kangjian Street Community Health Service Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taiquan Huang, Master
Phone
+8613918375404
Email
tqh957@sina.com.cn
Facility Name
Tianping Street Community Health Service Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin He, Master
Phone
+8613501903509
Email
hexin2050@163.com
Facility Name
Longhua Hospital Affiliated Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zifeng Ma, Master
Phone
+8618817338863
Email
mzf05@126.com
Facility Name
Fengxian District Hospital of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201400
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Fang, Master
Phone
+8613816856217
Email
13816856217@139.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Through this study, to find the appropriate treatment of traditional Chinese medicine, then to further promote

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Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

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