A Phase 2 interventional study of Baofeikang Granule and Placebo in Combined Pulmonary Fibrosis and Emphysema, sponsored by Beijing Municipal Science & Technology Commission. Status unknown at 2 sites in China. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by Beijing Municipal Science & Technology Commission · Phase 2, Interventional, and Treatment
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.
680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Beijing Municipal Science & Technology Commission is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Rejection criteria:
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
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
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.
Also known as: Treatment Group
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.
Also known as: Control Group
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
Time frame: Baseline and 3 months after the start of treatment
Changes from baselines in Chronic Obstructive Pulmonary Disease Assessment Test(CAT)at 3 months
Time frame: Baseline and 3 months after the start of treatment
Changes from baselines in Arterial blood gas analysis(ABG)at 3 months
Time frame: 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)
Time frame: 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
Time frame: Baseline and 1，2，3 months after the start of treatment
Forced Expiratory Volume in one second(FEV1)
pulmonary function
Time frame: Baseline and 3 months after the start of treatment
Forced Vital Capacity(FVC)
pulmonary function
Time frame: Baseline and 3 months after the start of treatment
Total Lung Capacity(TLC)
pulmonary function
Time frame: Baseline and 3 months after the start of treatment
Diffusion capacity for Carbon monoxide of the Lung(DLCO)
pulmonary function
Time frame: Baseline and 3 months after the start of treatment
Number of participants with adverse events
Blood routine examination,Liver and Renal function,Electrocardiogram
Time frame: Before treatment and 1，2，3 months after the start of treatment
Chronic Obstructive Pulmonary Disease Assessment Test(CAT)
This is the follow-up index.
Time frame: 1，3，6 months after the course of treatment
frequence of acute exacerbation of cough,sputum,dyspnea
This is the follow-up index.
Time frame: 1，3，6 months after the course of treatment
Plan to share: Yes
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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Beijing Municipal Science & Technology Commission