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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 45 Years - 75 Years
Gender All
More Inclusion & Exclusion 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;

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02805699

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Beijing Municipal Science & Technology Commission

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
hongsheng cui, Ph.D,Professorweibo Bi, Masterjianjun Wu, Masterruifeng Jin, Masterchang'an Li, Masterminmin Shan, Masterqiuyi Chen, Bachelorshengtao li, Bachelor
Principal Investigator Affiliation The Third Affiliated Hospital of Beijing University of Chinese MedicineThe Third Affiliated Hospital of Beijing University of Chinese MedicineThe Third Affiliated Hospital of Beijing University of Chinese MedicineThe Third Affiliated Hospital of Beijing University of Chinese MedicineThe Third Affiliated Hospital of Beijing University of Chinese MedicineThe Third Affiliated Hospital of Beijing University of Chinese MedicineThe Third Affiliated Hospital of Beijing University of Chinese MedicineThe Third Affiliated Hospital of Beijing University of Chinese Medicine

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Combined Pulmonary Fibrosis and Emphysema
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Dongzhimen hospital, Beijing, Beijing, China

Status

Recruiting

Address

Dongzhimen hospital

Beijing, Beijing,

Site Contact

Lishan Zhang

lszh111@sina.com

010-52075411

Beijing, Beijing, China

Status

Recruiting

Address

Beijing University of Chinese Medicine Third Affiliated Hospital

Beijing, Beijing, 100029

Site Contact

fei han

kymbxz@126.com

010-52075251

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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