Clinical study on huashanshen dripping pills in the treatment of stable chronic obstructive pulmonary disease
- Conditions
- Stable stage of chronic obstructive pulmonary disease
- Registration Number
- ITMCTR2100004651
- Lead Sponsor
- The Second Affiliated Hospital of Tianjin University of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the diagnostic criteria of COPD.
2. Accord with the syndrome differentiation standard of lung spleen kidney deficiency and phlegm stasis syndrome (non heat syndrome) in the stable stage of lung distension.
3. 40 years old = 80 years old.
4. The patient was diagnosed with COPD at least 12 months before the screening visit (according to the diagnostic criteria of gold 2020 guidelines), and had entered a stable period of more than 1 month before the screening visit, and the maintenance treatment plan met the basic treatment requirements of gold 2020 guidelines.
5. Severity of COPD: MMRC dyspnea severity grade = 1.
6. There was at least one history of disease aggravation within 12 months before the screening visit, and there was a record of using inhaled short acting bronchodilator (salbutamol sulfate) as a rapid remission drug.
7. The subjects are willing and able to adjust the current COPD treatment according to the protocol requirements.
8. Voluntarily participate in the clinical trial and sign the informed consent.
1. In addition to COPD, there are known respiratory diseases that may affect the efficacy of the study drug, including but not limited to asthma, a - 1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension and interstitial lung disease.
2. Patients need to use the following drugs: A. systemic steroids were used for the treatment of COPD exacerbation within 4 weeks before screening. b. Within 4 weeks before screening, the course of antibiotic treatment for COPD exacerbation was more than 7 days. c. Phosphodiesterase (PDE) inhibitors were used within 4 weeks before screening. d. Antibiotics were used to treat lower respiratory tract infections (e.g. pneumonia) within 4 weeks before screening.
3. Patients need long-term inhalation of bronchodilators containing long-acting anticholinergic drugs as basic treatment.
4. Patients need long-term (at least 12 hours a day) oxygen for the treatment of chronic hypoxemia.
5. The abnormality of chest X-ray or CT scan with clinical significance is not caused by COPD.
6. Syndrome differentiation of traditional Chinese medicine is phlegm heat obstructing lung, excessive lung heat, yin deficiency and lung heat.
7. Patients with angle closure glaucoma and third degree prostatic hypertrophy.
8. Patients with elevated AST and / or ALT = 2 times the upper limit of normal reference value, or SCR > the upper limit of normal reference value.
9. Patients with uncontrolled cardiovascular and cerebrovascular diseases, diabetes or other serious diseases such as hematopoietic system.
10. Patients with severe cognitive impairment or mental disorder, unable to complete the test, informed, unable to cooperate with clinical treatment and evaluation.
11. Pregnant or lactating women, or patients who wish to have children during the trial.
12. Participants in other clinical studies within 30 days before screening.
13. Allergic to the components of the study drug.
14. Association with the research center: the researcher, secondary researcher, research coordinator or employee of the researcher who is participating in the study or the immediate family members of the above-mentioned personnel are not allowed to participate in the study.
15. Patients who are not suitable for inclusion or for other reasons determined by researchers.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FEV1\FEV1%\FVC;
- Secondary Outcome Measures
Name Time Method Time of first moderate or severe exacerbation of COPD;Changes in the average daily use of salbutamol over a 4-week period relative to baseline;IL-23\IL-17\IL-10\IL-33\sST2\IL-4\TNF-a\TGF-ß\HIF-1a\NO\ET-1\VEGF;SGRQ;Vital signs before administration at baseline and at all visits;CAT;AE and ADR;The change of TCM syndrome integral;Frequency of AECOPD;Clinical laboratory examination;Colour Sonography;BODE;Six minute walk test;ECG;The change of the average number of times that needed temporary medication to relieve wheezing symptoms within 4 weeks compared with the baseline;mMRC;