Effect of Jianpiyifei II granule on patients with mild to moderate Chronic Obstructive Pulmonary Disease (COPD): a randomized controlled clinical trial
- Conditions
- Chronic obstructive pulmonary disease
- Registration Number
- ITMCTR2000003210
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Aged 40 to 85 years, both men and women;
2. A diagnosis of mild to moderate COPD which defined by the GOLD Guidelines as post-bronchodilator FEV1/FVC <0.7 and FEV1 >= 50% predicted value;
3. Stable COPD before screening, that is, no acute exacerbation at least 4 weeks prior to trial entry and no hospitalization for exacerbation in the past 3 months;
4. TCM syndrome differentiation is Qi deficiency syndrome or Qi deficiency is the main syndrome;
5. patients signed informed consent.
1. Had a history of asthma, bronchiectasis, lung cancer, active pulmonary tuberculosis and pneumonectomy;
2. Experienced frequent acute exacerbations (>=3 times) of COPD in the past year;
3. Had a blood eosinophil count >= 300/µL;
4. Frequent oral or intravenous corticosteroids (prednisone >10 mg/day);
5. TCM syndrome differentiation is excess syndrome and heat Syndrome;
6. Those who are not willing to accept the observation measures or can not cooperate because of mental illness;
7. Those who cannot complete the lung function test;
8. Those who took herbal medicines for strengthening the spleen and benefiting the lungs two weeks before the trial, or those who had undergone lung rehabilitation within three months, or planned to undergo lung rehabilitation during the study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ung function;
- Secondary Outcome Measures
Name Time Method mMRC;6-MWT;Frequency of COPD acute exacerbation;SGRQ;CAT;BODE index;