An interventional study of Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe and Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo in Acute Exacerbation Of Chronic Obstructive Pulmonary Disease, sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Henan University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
The purpose of this study was to evaluate the effects of Chinese Medicine on patients with severe AECOPD, and to provide a basis for the establishment of integrated CM and Western medicine diagnosis and treatment scheme for patients with severe AECOPD.
Aiming at the key problems such as the lack of high-quality clinical research evidence of Chinese medicine in the prevention and treatment of severe AECOPD, this study adopted a multi-center, randomized, double-blind, placebo-controlled parallel trial design, taking 468 severe AECOPD patients as the research object, to evaluate the clinical efficacy and safety of Chinese medicine combined with western medicine in the treatment of severe AECOPD. To establish an integrated Chinese and western medicine diagnosis and treatment plan to reduce the treatment failure rate of severe AECOPD patients, and to form high-level evidence-based evidence.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's planned enrollment of 468 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Henan University of Traditional Chinese Medicine is the lead sponsor of 52 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
On the basis of conventional western medicine treatment, the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days.
Drug: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe
On the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days.
Drug: Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo
On the basis of conventional treatment of western medicine,the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days.
On the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days.
Treatment failure rate
The number of treatment failures in both groups during the study period was measured. Treatment failure was defined as the following: (1) the need for or receipt of tracheal intubation or invasive mechanical ventilation during hospitalization, or (2) the need for or transfer to an intensive care unit during hospitalization, or (3) the duration of hospitalization for the current acute exacerbation of COPD for more than 14 days, or (4) death during hospitalization or within 30 days after discharge, or (5) readmission for an acute exacerbation of COPD within 30 days after discharge.
Time frame: During the 10 days treatment period and the 3 months follow-up period.
The COPD Assessment Test(CAT)
The COPD Assessment Test (CAT) is an 8-item questionnaire that assesses health status in patients with COPD. The questionnaire uses a 0-5 point scale, with higher values indicating a greater impact of COPD on the patient.
Time frame: Changes in baseline CAT scores at day 10 of the treatment period and at 1 and 3 months of follow-up.
The number and severity of acute exacerbations
The number and severity of acute exacerbations during the follow-up period.
Time frame: Within 3 months of follow-up period.
Readmission rate of acute exacerbations
The number of readmissions due to acute exacerbations during the follow-up period.
Time frame: Within 3 months of follow-up period.
The time to the first exacerbation of COPD
The time to the first COPD exacerbation during the study period.
Time frame: Within 3 months of follow-up period.
Dyspnea score
The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea. The mMRC scale is a 4-point (0-4) scale. "0" means no dyspnea perception, "4" means severe dyspnea perception.
Time frame: Changes in baseline mMRC scores at days 4, 7, and 10 of the treatment period and at 1 and 3 months of follow-up.
COPD Acute exacerbation tool (EXACT) score
The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) is a questionnaire that assesses symptoms in patients with COPD. The questionnaire is on a scale from 0 to 5, with higher values indicating a greater impact of COPD on the patient.
Time frame: 0 and 10 days in the treatment period, 1 and 3 months in the follow-up period.
Length of hospital stay
Through study /treatment phase completion,an average of 10 days.
Time frame: During the 10 days treatment period and the 3 months follow-up period.
Antibacterial application time
The antibacterial application time of each group of subjects was counted.
Time frame: During the 10 days treatment period and the 3 months follow-up period.
Endotracheal intubation rate
The number of endotracheal intubation cases in the two groups during the treatment period was calculated.
Time frame: In 10 days of the treatment period.
Case fatality rate
The number of deaths due to AECOPD in the two groups during the study period was counted.
Time frame: During the 10 days treatment period and the 3 months follow-up period.
No study locations are listed for this record.
Plan to share: No
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Henan University of Traditional Chinese Medicine