NCT02805699

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2016

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

June 6, 2016

Last Update Submit

August 29, 2017

Conditions

Combined Pulmonary Fibrosis and Emphysema

Keywords

Clinical EfficacyBaofeikang GranulesCombined Pulmonary Fibrosis and Emphysema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • 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

    Baseline and 1，2，3 months after the start of treatment

  • Forced Expiratory Volume in one second(FEV1)

    Baseline and 3 months after the start of treatment

  • +3 more secondary outcomes

Other Outcomes (3)

  • Number of participants with adverse events

    Before treatment and 1，2，3 months after the start of treatment

  • Chronic Obstructive Pulmonary Disease Assessment Test(CAT)

    1，3，6 months after the course of treatment

  • frequence of acute exacerbation of cough,sputum,dyspnea

    1，3，6 months after the course of treatment

Study Arms (2)

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.

Drug: Baofeikang Granule

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.

Drug: Placebo

Interventions

Baofeikang GranuleDRUG

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.

Also known as: Treatment Group
Baofeikang Granule
PlaceboDRUG

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.

Also known as: Control Group
Placebo

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • conform to Combined Pulmonary Fibrosis and Emphysema Treatment diagnostic criteria;
  • conform to Qi and yin deficiency, phlegm and blood stasis syndrome diagnosis standard;
  • Patients with non acute episode;
  • Age between 45-75 (including 45 and 75);
  • signed the informed consent.

You may not qualify if:

  • Combined upper and lower respiratory infection, pulmonary tuberculosis, lung cancer or other lung diseases;
  • Combined with diabetes, cardiovascular, liver, kidney or hematopoietic system diseases, psychiatric patients;
  • Pregnancy and lactation patients;
  • Allergic to the subjects of the medicine.
  • Rejection criteria:
  • the discovery of serious physical illness after entering the group;
  • do not follow the program medication of patients;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing University of Chinese Medicine Third Affiliated Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Dongzhimen hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Emphysema

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • 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

  • 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

Central Study Contacts

hongsheng Cui, Ph.D，Professor

CONTACT

010-54075410hshcui@sina.com

chang'an Li, Master

CONTACT

010-52075411

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Respiration of Beijing University of Chinese Medicine Third Affiliated Hospital

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 20, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

August 30, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

Locations

CN(2)