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

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ClinicalTrials.gov Identifier: NCT02805699
Recruitment Status : Unknown
Verified August 2017 by Cui Hongsheng, Beijing Municipal Science & Technology Commission.
Recruitment status was:  Recruiting
First Posted : June 20, 2016
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Cui Hongsheng, Beijing Municipal Science & Technology Commission

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.

Condition or disease Intervention/treatment Phase
Combined Pulmonary Fibrosis and Emphysema Drug: Baofeikang Granule Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Beijing Municipal Science and Technology Commission
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Baofeikang Granule
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.
Other Name: Treatment Group

Placebo Comparator: 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.
Drug: Placebo
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.
Other Name: Control Group




Primary Outcome Measures :
  1. Changes from baseline in the efficacy of TCM syndrome index at 3 months [ Time Frame: 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


Secondary Outcome Measures :
  1. 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 ]
  2. Changes from baselines in Arterial blood gas analysis(ABG)at 3 months [ Time Frame: Baseline and 3 months after the start of treatment ]
  3. 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 ]
  4. Changes from baselines in frequence of acute exacerbation of cough,sputum,dyspnea at 1,2,3 months [ Time Frame: Baseline and 1,2,3 months after the start of treatment ]
    acute exacerbation defined as involving symptoms lasting for >2 days , leading to treatment with systemic glucocorticoids, antibiotics, hospitalization or emergency

  5. Forced Expiratory Volume in one second(FEV1) [ Time Frame: Baseline and 3 months after the start of treatment ]
    pulmonary function

  6. Forced Vital Capacity(FVC) [ Time Frame: Baseline and 3 months after the start of treatment ]
    pulmonary function

  7. Total Lung Capacity(TLC) [ Time Frame: Baseline and 3 months after the start of treatment ]
    pulmonary function

  8. Diffusion capacity for Carbon monoxide of the Lung(DLCO) [ Time Frame: Baseline and 3 months after the start of treatment ]
    pulmonary function


Other Outcome Measures:
  1. Number of participants with adverse events [ Time Frame: Before treatment and 1,2,3 months after the start of treatment ]
    Blood routine examination,Liver and Renal function,Electrocardiogram

  2. Chronic Obstructive Pulmonary Disease Assessment Test(CAT) [ Time Frame: 1,3,6 months after the course of treatment ]
    This is the follow-up index.

  3. frequence of acute exacerbation of cough,sputum,dyspnea [ Time Frame: 1,3,6 months after the course of treatment ]
    This is the follow-up index.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805699


Contacts
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Contact: hongsheng Cui, Ph.D,Professor 010-54075410 hshcui@sina.com
Contact: chang'an Li, Master 010-52075411

Locations
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China, Beijing
Beijing University of Chinese Medicine Third Affiliated Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: fei han    010-52075251    kymbxz@126.com   
Contact: changan li    010-52075411    lichangan1989@163.com   
Principal Investigator: Hongsheng Cui, Ph.D         
Sub-Investigator: Chang'an Li, Master         
Sub-Investigator: Weibo Bi, Master         
Sub-Investigator: Jianjun Wu, Master         
Sub-Investigator: Ruifeng Jin, Master         
Sub-Investigator: Minmin Shan, Master         
Sub-Investigator: Qiuyi Chen, Master         
Dongzhimen hospital Recruiting
Beijing, Beijing, China
Contact: Lishan Zhang    010-52075411    lszh111@sina.com   
Sponsors and Collaborators
Beijing Municipal Science & Technology Commission
Investigators
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Study Chair: hongsheng cui, Ph.D,Professor The Third Affiliated Hospital of Beijing University of Chinese Medicine
Principal Investigator: weibo Bi, Master The Third Affiliated Hospital of Beijing University of Chinese Medicine
Principal Investigator: 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

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Responsible Party: Cui Hongsheng, Director of Department of Respiration of Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing Municipal Science & Technology Commission
ClinicalTrials.gov Identifier: NCT02805699     History of Changes
Other Study ID Numbers: Z161100000516055
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Cui Hongsheng, Beijing Municipal Science & Technology Commission:
Clinical Efficacy
Baofeikang Granules
Combined Pulmonary Fibrosis and Emphysema
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Pulmonary Emphysema
Fibrosis
Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Expectorants
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Respiratory System Agents