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NCT06134063 | RECRUITING | Acute Exacerbation of Chronic Obstructive Pulmonary Disease

A Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Sponsor:

Peking University People's Hospital

Information provided by (Responsible Party):

C UI command F 鞞

Brief Summary:

This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial. This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment. If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.

Condition or disease

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Intervention/treatment

Xuanfei Baidu granule

Xuanfei Baidu granule Placebo

Phase

NA

Detailed Description:

This study is a prospective,multicenter, randomized, double-blind, placebo-controlled trial. This study plans to enroll 375 participants who will be randomly assigned in a 2:1 ratio. On the basis of basic treatment, one group will receive Xuanfei Baidu granule, while the other group will receive Xuanfei Baidu granule placebo, with one sachet in the morning and one in the evening, for a duration of 7 days. Visits will be conducted on days 7, 14, and 21 after enrollment. If any participant experiences an acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring hospitalization during the treatment period, they will continue taking the medication until the 7-day course is completed. In case of a COPD exacerbation hospitalization event during the study, hospital admission date, duration of hospitalization, and the treatment regimen during hospitalization will be recorded.

Study Type : INTERVENTIONAL
Estimated Enrollment : 375 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Actual Study Start Date : 2023-11
Estimated Primary Completion Date : 2024-12
Estimated Study Completion Date : 2025-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Aged between 40 and 80 years old, including 40 and 80 years old, regardless of gender;
  • * Clinical records of traceable of the chronic obstructive pulmonary disease history records, after bronchodilator FEV1 less than 80% of the expected value;
  • * Comply with the definition of COPD acute exacerbations and with mild and moderate severity assessment;
  • * Symptoms of AECOPD time less than 48 h;
  • * "Shiduyufei" diagnostic standard;
  • * Volunteered for the study, signed informed consent, is willing to cooperate with the visitor.
Exclusion Criteria
  • * Patients showing signs of hospitalization;
  • * With respiratory system diseases other than the AECOPD (for example, pneumonia, bronchiectasis, active tuberculosis, pneumothorax, pleural effusion, pulmonary embolism, or affect the respiratory movement function of neuromuscular diseases, etc.);
  • * Patients with severe basic diseases (for example, uncontrolled hypertension diabetes and complicated with heart failure (NYHA class IV), severe arrhythmia, acute coronary syndrome, hemodynamic instability, long-term use of immunosuppressive agents, etc.);
  • * With primary disease such as tumor or blood system;
  • * With severe liver disease (cirrhosis, portal hypertension, varices bleeding) or renal insufficiency;
  • * Pregnant women and breastfeeding mothers, those suspected of being pregnant, or women of childbearing age at risk of pregnancy who have not taken effective contraceptive measures;
  • * Dementia, mental disorders, such as unable to read or understand the research content, the information collection;
  • * With drug allergy;
  • * 3 months prior to screening for other interventional clinical research and the research data information;
  • * Within 1 week before screening been oral Chinese medicine or other proprietary Chinese medicine treatment;
  • * Patient refused to sign a consent form, or estimate adherence is poor, or follow-up possibilities is poor.
A Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Location Details

NCT06134063

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Locations

RECRUITING

China,

Peking University People's Hospital

Beijing, China,