Combined Pulmonary Fibrosis and Emphysema Clinical Trial
Official title:
Beijing Municipal Science and Technology Commission
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.
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.
1. 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.
2. Drug coding According to the protocol,the experimental duration of treatment is 3
months.The patients accept the medication for each month.
3. Blind method In the course of the study, the researchers and the subjects were not aware
of the grouping of the research objects.
4. 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.
5. 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.
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