Clinical trial NCT02805699: A Clinical Evaluation of Baofeikang Granule in Combined Pulmonary Fibrosis and Emphysema Treatment
Official title: Beijing Municipal Science and Technology Commission
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Combined Pulmonary Fibrosis and Emphysema
Keywords: Clinical Efficacy
Baofeikang Granules
Combined Pulmonary Fibrosis and Emphysema
Lead sponsor: Beijing Municipal Science & Technology Commission
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. conform to Combined Pulmonary Fibrosis and Emphysema Treatment diagnostic criteria;
2. conform to Qi and yin deficiency, phlegm and blood stasis syndrome diagnosis standard;
3. Patients with non acute episode;
4. Age between 45-75 (including 45 and 75);
5. signed the informed consent.

Exclusion Criteria:

1. Combined upper and lower respiratory infection, pulmonary tuberculosis, lung cancer or other lung diseases;
2. Combined with diabetes, cardiovascular, liver, kidney or hematopoietic system diseases, psychiatric patients;
3. Pregnancy and lactation patients;
4. Allergic to the subjects of the medicine.

Rejection criteria:

1. do not meet the inclusion criteria after entering the group;
2. the discovery of serious physical illness after entering the group;
3. do not follow the program medication of patients;

Primary outcomes:
measure: Changes from baseline in the efficacy of TCM syndrome index at 3 months
timeFrame: Baseline and 3 months after the start of treatment
Secondary outcomes:
measure: Changes from baselines in Chronic Obstructive Pulmonary Disease Assessment Test(CAT)at 3 months
timeFrame: Baseline and 3 months after the start of treatment
measure: Changes from baselines in Arterial blood gas analysis(ABG)at 3 months
timeFrame: Baseline and 3 months after the start of treatment
measure: The scope and degree of fibrosis and emphysema of pulmonary in chest High Resolution Computerized Tomography(HRCT)
timeFrame: Baseline and 3 months after the start of treatment
measure: Changes from baselines in frequence of acute exacerbation of cough,sputum,dyspnea at 1,2,3 months
timeFrame: Baseline and 1，2，3 months after the start of treatment
measure: Forced Expiratory Volume in one second(FEV1)
timeFrame: Baseline and 3 months after the start of treatment
measure: Forced Vital Capacity(FVC)
timeFrame: Baseline and 3 months after the start of treatment
measure: Total Lung Capacity(TLC)
timeFrame: Baseline and 3 months after the start of treatment
measure: Diffusion capacity for Carbon monoxide of the Lung(DLCO)
timeFrame: Baseline and 3 months after the start of treatment
Other outcomes:
measure: Number of participants with adverse events
timeFrame: Before treatment and 1，2，3 months after the start of treatment
measure: Chronic Obstructive Pulmonary Disease Assessment Test(CAT)
timeFrame: 1，3，6 months after the course of treatment
measure: frequence of acute exacerbation of cough,sputum,dyspnea
timeFrame: 1，3，6 months after the course of treatment
Locations:
city: Beijing
country: China
facility: Beijing University of Chinese Medicine Third Affiliated Hospital
state: Beijing
city: Beijing
country: China
facility: Dongzhimen hospital
state: Beijing
Study officials:
affiliation: The Third Affiliated Hospital of Beijing University of Chinese Medicine
name: hongsheng cui, Ph.D，Professor
role: STUDY_CHAIR
affiliation: The Third Affiliated Hospital of Beijing University of Chinese Medicine
name: weibo Bi, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated Hospital of Beijing University of Chinese Medicine
name: jianjun Wu, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated Hospital of Beijing University of Chinese Medicine
name: ruifeng Jin, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated Hospital of Beijing University of Chinese Medicine
name: chang'an Li, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated Hospital of Beijing University of Chinese Medicine
name: minmin Shan, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated Hospital of Beijing University of Chinese Medicine
name: qiuyi Chen, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated Hospital of Beijing University of Chinese Medicine
name: shengtao li, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: