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

August 29, 2017 updated by: Cui Hongsheng, Beijing Municipal Science & Technology Commission

Beijing Municipal Science and Technology Commission

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: hongsheng Cui, Ph.D，Professor
  • Phone Number: 010-54075410
  • Email: hshcui@sina.com

Study Contact Backup

  • Name: chang'an Li, Master
  • Phone Number: 010-52075411

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing University of Chinese Medicine Third Affiliated Hospital
        • Contact:
        • Contact:
        • 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
      • Beijing, Beijing, China
        • Recruiting
        • Dongzhimen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 3 months after the start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
Baseline and 1，2，3 months after the start of treatment
Forced Expiratory Volume in one second(FEV1)
Time Frame: Baseline and 3 months after the start of treatment
pulmonary function
Baseline and 3 months after the start of treatment
Forced Vital Capacity(FVC)
Time Frame: Baseline and 3 months after the start of treatment
pulmonary function
Baseline and 3 months after the start of treatment
Total Lung Capacity(TLC)
Time Frame: Baseline and 3 months after the start of treatment
pulmonary function
Baseline and 3 months after the start of treatment
Diffusion capacity for Carbon monoxide of the Lung(DLCO)
Time Frame: Baseline and 3 months after the start of treatment
pulmonary function
Baseline and 3 months after the start of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before treatment and 1，2，3 months after the start of treatment
Chronic Obstructive Pulmonary Disease Assessment Test(CAT)
Time Frame: 1，3，6 months after the course 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
Time Frame: 1，3，6 months after the course of treatment
This is the follow-up index.
1，3，6 months after the course of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Municipal Science & Technology Commission

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z161100000516055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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