Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

Shanghai University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 2

Conditions: Bronchial Asthma

Treatments: Drug: Zhi Chuan Capsule placebo; Drug: Xie Wu Capsule placebo; Drug: Ke Chuan Liu Wei Mixture; Drug: Dan Ma Jia Tablet placebo; Drug: Chuan Xiong Ping Chuan Mixture placebo; Drug: Chuan Xiong Ping Chuan Mixture; Drug: Xie Wu Capsule; Drug: Bu Shen Na Qi Granule; Drug: Ke Chuan Liu Wei Mixture placebo; Drug: Bu Shen Na Qi Granule placebo; Drug: Zhi Chuan Capsule; Drug: Dan Ma Jia Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT02937207

LH20161013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

288 participants in 8 patient groups, including a placebo group

Hanxiao treatment group

Experimental group

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.

Treatment:

Drug: Ke Chuan Liu Wei Mixture

Hanxiao control group

Placebo Comparator group

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.

Treatment:

Drug: Ke Chuan Liu Wei Mixture placebo

Fengtanxiao treatment group

Experimental group

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.

Treatment:

Drug: Xie Wu Capsule

Drug: Chuan Xiong Ping Chuan Mixture

Fengtanxiao control group

Placebo Comparator group

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.

Treatment:

Drug: Chuan Xiong Ping Chuan Mixture placebo

Drug: Xie Wu Capsule placebo

Rexiao treatment group

Experimental group

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.

Treatment:

Drug: Dan Ma Jia Tablet

Rexiao control group

Placebo Comparator group

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.

Treatment:

Drug: Dan Ma Jia Tablet placebo

Xuxiao treatment group

Experimental group

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.

Treatment:

Drug: Zhi Chuan Capsule

Drug: Bu Shen Na Qi Granule

Xuxiao control group

Placebo Comparator group

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.

Treatment:

Drug: Bu Shen Na Qi Granule placebo

Drug: Zhi Chuan Capsule placebo