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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baofeikang Granule | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baofeikang Granule | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 3 months after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Arterial blood gas analysis(ABG)at 3 months | Baseline and 3 months after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Blood routine examination,Liver and Renal function,Electrocardiogram | Before treatment and 1,2,3 months after the start of treatment |
| Chronic Obstructive Pulmonary Disease Assessment Test(CAT) |
Inclusion Criteria:
Exclusion Criteria:
Rejection criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hongsheng Cui, Ph.D,Professor | Contact | 010-54075410 | hshcui@sina.com | |
| chang'an Li, Master | Contact | 010-52075411 |
| Name | Affiliation | Role |
|---|---|---|
| hongsheng cui, Ph.D,Professor | The Third Affiliated Hospital of Beijing University of Chinese Medicine | Study Chair |
| weibo Bi, Master | The Third Affiliated Hospital of Beijing University of Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing University of Chinese Medicine Third Affiliated Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Placebo | Drug | 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. |
|
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| 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 |
| 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 | Baseline and 1,2,3 months after the start of treatment |
| Forced Expiratory Volume in one second(FEV1) | pulmonary function | Baseline and 3 months after the start of treatment |
| Forced Vital Capacity(FVC) | pulmonary function | Baseline and 3 months after the start of treatment |
| Total Lung Capacity(TLC) | pulmonary function | Baseline and 3 months after the start of treatment |
| Diffusion capacity for Carbon monoxide of the Lung(DLCO) | pulmonary function | Baseline and 3 months after the start of treatment |
This is the follow-up index.
| 1,3,6 months after the course of treatment |
| frequence of acute exacerbation of cough,sputum,dyspnea | This is the follow-up index. | 1,3,6 months after the course of treatment |
| jianjun Wu, Master | The Third Affiliated Hospital of Beijing University of Chinese Medicine | Principal Investigator |
| ruifeng Jin, Master | The Third Affiliated Hospital of Beijing University of Chinese Medicine | Principal Investigator |
| chang'an Li, Master | The Third Affiliated Hospital of Beijing University of Chinese Medicine | Principal Investigator |
| minmin Shan, Master | The Third Affiliated Hospital of Beijing University of Chinese Medicine | Principal Investigator |
| qiuyi Chen, Bachelor | The Third Affiliated Hospital of Beijing University of Chinese Medicine | Principal Investigator |
| shengtao li, Bachelor | The Third Affiliated Hospital of Beijing University of Chinese Medicine | Principal Investigator |
| Dongzhimen hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| D008722 | Methods |