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

Beijing Municipal Science & Technology Commission

Status and phase: Unknown; Phase 2

Conditions: Combined Pulmonary Fibrosis and Emphysema

Treatments: Drug: Baofeikang Granule; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02805699

Z161100000516055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Baofeikang Granule

Experimental group

Description:

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.

Treatment:

Drug: Baofeikang Granule

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo