A Clinical Evaluation of Baofeikang Granule in Combined Pulmonary Fibrosis and Emphysema Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the efficacy and safety of BaofeiKang Granule in the treatment of Combined Pulmonary Fibrosis and Emphysema patients.

Detailed Description
-----------------
A randomized, double blinded, placebo controlled study is conducted to observe the efficacy and safety of BaoFeiKang Granule in the treatment of patients with Combined Pulmonary Fibrosis and Emphysema. The Traditional Chinese Medicine（TCM） syndrome intergal,lung function ,Chronic Obstructive Pulmonary Disease Assessment Test（CAT）score, acute exacerbation, arterial blood gas analysis, chest High Resolution Computerized Tomography （HRCT）and liver and kidney function are to be calculated and tested before and after the trial. Randomization All the selected cases is divided into the experimental group and the control group randomly, and the section size is 6. STATISTICAL ANALYSIS SYSTEM（SAS）statistical software are randomly assigned table，and clinical researchers given the corresponding code number to the selected qualified patients.According to the code number,patients receive the corresponding code number box.The persons who generate and preserve of tables are not involved in clinical trials. Drug coding According to the protocol,the experimental duration of treatment is 3 months.The patients accept the medication for each month. Blind method In the course of the study, the researchers and the subjects were not aware of the grouping of the research objects. Sample size According to the formula,n=(Uα+Uβ)2*2P(1-P)/(P1-P0),the required sample size of each group is calculated.P1 represents for the efficiency of treatment group, P0 for the control group, P= (P1+P0) /2 * 100%;α＝0.05，β＝0.10，Uα=1.65，Uβ=1.28.According to the previous research results and literature research,P1=70%,P0=40%.It is calculated n = 47,and considering shedding rate of 20%,n =56.So actual each group includes 60 patients. Implementation and management (1) training of 4 clinical researchers to master case collection methods and evaluation methods to minimize selection bias; (2) all experimental drugs are used in the same batch of drugs. (3) to collect data of the combination of medication and the treatment to exclude the impact of the above interference; (4) inform patients to get a more comprehensive evaluation and follow-up treatment.Special problems can get all respiratory department doctor's consultation, so as to achieve patient cooperation and understanding.(5)List the cases of loss or withdrawal, and specify the details and reasons.

Official Title
-----------------
Beijing Municipal Science and Technology Commission

Conditions
-----------------
Combined Pulmonary Fibrosis and Emphysema

Intervention / Treatment
-----------------
* Drug: Baofeikang Granule
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: conform to Combined Pulmonary Fibrosis and Emphysema Treatment diagnostic criteria; conform to Qi and yin deficiency, phlegm and blood stasis syndrome diagnosis standard; Patients with non acute episode; Age between 45-75 (including 45 and 75); signed the informed consent. Exclusion Criteria: Combined upper and lower respiratory infection, pulmonary tuberculosis, lung cancer or other lung diseases; Combined with diabetes, cardiovascular, liver, kidney or hematopoietic system diseases, psychiatric patients; Pregnancy and lactation patients; Allergic to the subjects of the medicine. Rejection criteria: do not meet the inclusion criteria after entering the group; the discovery of serious physical illness after entering the group; do not follow the program medication of patients;

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baofeikang Granule<br>On the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant,cough,give BaoFeikang Granules(by Beijing KangRentang Pharmaceutical Co., Ltd.), 1 bag, twice each day. | Drug: Baofeikang Granule<br>* To observe the efficacy and safety of Baofeikang granules on Combined Pulmonary Fibrosis and Emphysema Treatment.Baofeikang Granules consist of（Codonopsis 30g, Cordyceps fungi powder 12g, ophiopogon root 10g, Schisandra 10g, angelica 15g, Bulbus Fritillariae thunbergii 10g, Sophora flavescens 10g,Forsythia suspensa 12g，Pinellia 10g, saponins thorn 10g, Radix Peucedani 10g）.1 bags,P.O（Oral）twice of each 3 months cycle.<br>* Other names: Treatment Group;|
| Placebo Comparator: Placebo<br>On the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant,coughand give Chinese medicine placebo (by Beijing Kang Rentang Pharmaceutical Co., Ltd., requirements and Chinese medicine BaoFeikang Granules in appearance and taste similar),1bag，twice each day. | Drug: Placebo<br>* On the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant, cough ， give Chinese medicine placebo,1 bags,P.O（Oral）twice of each 3 months cycle.<br>* Other names: Control Group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in the efficacy of TCM syndrome index at 3 months | Observe the changes of the symptoms of wheezing, chest congestion, cough, shortness of breath and etc | Baseline and 3 months after the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baselines in Chronic Obstructive Pulmonary Disease Assessment Test(CAT)at 3 months |  | Baseline and 3 months after the start of treatment | 
| Changes from baselines in Arterial blood gas analysis(ABG)at 3 months |  | Baseline and 3 months after the start of treatment | 
| The scope and degree of fibrosis and emphysema of pulmonary in chest High Resolution Computerized Tomography(HRCT) |  | Baseline and 3 months after the start of treatment | 
| Changes from baselines in frequence of acute exacerbation of cough,sputum,dyspnea at 1,2,3 months | acute exacerbation defined as involving symptoms lasting for >2 days , leading to treatment with systemic glucocorticoids, antibiotics, hospitalization or emergency | Baseline and 1，2，3 months after the start of treatment | 
| Forced Expiratory Volume in one second(FEV1) | pulmonary function | Baseline and 3 months after the start of treatment | 
| Forced Vital Capacity(FVC) | pulmonary function | Baseline and 3 months after the start of treatment | 
| Total Lung Capacity(TLC) | pulmonary function | Baseline and 3 months after the start of treatment | 
| Diffusion capacity for Carbon monoxide of the Lung(DLCO) | pulmonary function | Baseline and 3 months after the start of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Efficacy, Baofeikang Granules, Combined Pulmonary Fibrosis and Emphysema