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

Combined Pulmonary Fibrosis and Emphysema Clinical Trial

Official title:

Beijing Municipal Science and Technology Commission

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02805699
• Other study ID #: Z161100000516055
• Status: Recruiting
• Phase: Phase 2
• First received: June 6, 2016
• Last updated: August 29, 2017
• Start date: June 2016
• Est. completion date: September 2019

Study information

• Verified date: August 2017
• Source: Beijing Municipal Science & Technology Commission
• Contact: hongsheng Cui, Ph.D,Professor
• Phone: 010-54075410
• Email: hshcui[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Combined Pulmonary Fibrosis and Emphysema
• Emphysema
• Fibrosis
• Pulmonary Emphysema
• Pulmonary Fibrosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing University of Chinese Medicine Third Affiliated Hospital	Beijing	Beijing
China	Dongzhimen hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Chronic Obstructive Pulmonary Disease Assessment Test(CAT)	This is the follow-up index.	1,3,6 months after the course of treatment
Other	frequence of acute exacerbation of cough,sputum,dyspnea	This is the follow-up index.	1,3,6 months after the course of treatment
Primary	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
Secondary	Changes from baselines in Chronic Obstructive Pulmonary Disease Assessment Test(CAT)at 3 months		Baseline and 3 months after the start of treatment
Secondary	Changes from baselines in Arterial blood gas analysis(ABG)at 3 months		Baseline and 3 months after the start of treatment
Secondary	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
Secondary	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
Secondary	Forced Expiratory Volume in one second(FEV1)	pulmonary function	Baseline and 3 months after the start of treatment
Secondary	Forced Vital Capacity(FVC)	pulmonary function	Baseline and 3 months after the start of treatment
Secondary	Total Lung Capacity(TLC)	pulmonary function	Baseline and 3 months after the start of treatment
Secondary	Diffusion capacity for Carbon monoxide of the Lung(DLCO)	pulmonary function	Baseline and 3 months after the start of treatment