Beijing Municipal Science and Technology Commission
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes from baseline in the efficacy of TCM syndrome index at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Baofeikang Granule
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.
干预措施: Baofeikang Granule (Drug)
Placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in the efficacy of TCM syndrome index at 3 months
时间窗: Baseline and 3 months after the start of treatment
Observe the changes of the symptoms of wheezing, chest congestion, cough, shortness of breath and etc
次要结局
- 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 frequence of acute exacerbation of cough,sputum,dyspnea at 1,2,3 months(Baseline and 1，2，3 months after the start of treatment)
- Forced Expiratory Volume in one second(FEV1)(Baseline and 3 months after the start of treatment)
- Forced Vital Capacity(FVC)(Baseline and 3 months after the start of treatment)
- Total Lung Capacity(TLC)(Baseline and 3 months after the start of treatment)
- Diffusion capacity for Carbon monoxide of the Lung(DLCO)(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)
研究者
Cui Hongsheng
Director of Department of Respiration of Beijing University of Chinese Medicine Third Affiliated Hospital
Beijing Municipal Science & Technology Commission