Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

Bronchial Asthma Clinical Trial

Official title:

Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02937207
• Other study ID #: LH20161013
• Status: Recruiting
• Phase: Phase 2
• Start date: July 30, 2017
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Zifeng Ma, Master
• Phone: +8602164385700
• Email: mzf05[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Ke Chuan Liu Wei Mixture
Experience formula of famous traditional Chinese professor Yingen Wu
• Chuan Xiong Ping Chuan Mixture
Experience formula of famous traditional Chinese professor Changrong Shao
• Xie Wu Capsule
Experience formula of famous traditional Chinese professor Jianhua Hu
• Dan Ma Jia Tablet
Experience formula of famous traditional Chinese professor Xiaopu Xu
• Zhi Chuan Capsule
Experience formula of famous traditional Chinese professor Yingen Wu
• Bu Shen Na Qi Granule
Experience formula of famous traditional Chinese professor Changrong Shao
• Ke Chuan Liu Wei Mixture placebo
Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
• Chuan Xiong Ping Chuan Mixture placebo
Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
• Xie Wu Capsule placebo
Low dose combination for treating prescription of Xie Wu Capsule
• Dan Ma Jia Tablet placebo
Low dose combination for treating prescription of Dan Ma Jia Tablet
• Zhi Chuan Capsule placebo
Low dose combination for treating prescription of Zhi Chuan Capsule
• Bu Shen Na Qi Granule placebo
Low dose combination for treating prescription of Bu Shen Na Qi Granule

Locations

Country	Name	City	State
China	Fenglin Street Community Health Service Center	Shanghai	Shanghai
China	Fengxian District Hospital of TCM	Shanghai	Shanghai
China	Kangjian Street Community Health Service Center	Shanghai	Shanghai
China	Longhua Hospital Affiliated Shanghai University of TCM	Shanghai	Shanghai
China	Tianping Street Community Health Service Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Liver function test	Measured Liver function	up to 12 months
Secondary	Kidney function test	Measured Kidney function	up to 12 months
Secondary	T cell classification	Measured T cell classification of PBMC	up to 12 months
Secondary	Cytokine levels of induced sputum	Measured cytokine levels of induced sputum supernatant	up to 12 months