chronic obstructive pulmonary disease, pulmonary hypertension
Conditions
Interventions
Treatment group 1:The dosage of sodium tanshinone ?A sulfonate injection was 80mg, and 5% glucose injection was 250ml (patients with diabetes or other subjects who were not suitable for glucose inject
Treatment group 2:The dosage of ligustrazine hydrochloride injection was 80mg, and 5% glucose injection was 250ml (patients with diabetes or other subjects who were not suitable for glucose injection
Treatment group 3:The dosage of Bufei Huoxue capsule was 1.4g/ time, taken orally, three times a day, for 12 months.
Sponsors
State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with COPD, GOLD III-VI stage: Measured 20 minutes after inhaling salbutamol 400ug, FEV1/FVC < 70%, and FEV1 < 50% of the predicted value. 2. Age: 40-80 years old, no gender restrictions, community or outpatient cases. 3. Patients are in a stable condition and have not experienced exacerbation within the last 4 weeks. 4. Patients are capable of verbal or written communication and have the ability to complete auxiliary examinations related to the trial. 5. The subject or their legal guardian agrees to participate in this trial and signs the informed consent form. 6. If there is concomitant pulmonary arterial hypertension, there should be no targeted drug treatment for at least 1 month.
Exclusion criteria
Exclusion criteria: 1. Major diseases other than COPD with PH. The definition of major diseases is: any disease or condition that, in the judgment of the investigator, may place the subject at risk due to participation in the trial, or may affect the trial results or the subject's ability to participate in the trial, such as severe heart, brain, kidney, blood system diseases, or malignant tumors, etc., and diseases primarily characterized by bronchiectasis, pneumoconiosis, interstitial lung disease, sleep apnea, alveolar hypoventilation syndrome, or other lung diseases with concurrent restrictive and obstructive ventilatory impairments, etc.; 2. Women who are pregnant or breastfeeding; 3. Patients with mental or physical disabilities whom the responsible physician deems unsuitable for enrollment; 4. Significantly abnormal laboratory test indicators, including: ALT more than three times the upper limit of normal, Ccr 170/110mmHg); 5. Individuals known to be allergic to any component of the study medication; 6. Individuals with active infectious diseases such as hepatitis A, hepatitis B, AIDS, tuberculosis, or connective tissue diseases; 7. Patients who need to take or are currently taking medications that may or are known to affect this experiment (such as caffeine, acetaminophen, verapamil, clozapine); 8. Patients with acute or chronic organic diseases (except for dyspnea) or other reasons such as lower limb diseases that prevent the subject from completing the required monitoring and adherence items in the study (especially the 6-minute walk test); 9. Patients with life-threatening pulmonary embolism, or a1-antitrypsin deficiency, or cystic fibrosis; 10. Patients who have undergone pulmonary resection; 11. Patients with an acute exacerbation of COPD within 4 weeks prior to the initial visit (V0), or those who require hospitalization and/or antibiotics and/or oral or intravenous steroid treatment during the enrollment period; 12. Patients who have used an experimental drug within 30 days or six half-lives (whichever is longer) prior to the initial visit (V0); 13. Patients who are currently participating in other clinical trials; 14. Individuals with a history of chronic alcohol abuse, drug abuse, or factors affecting compliance; 15. Any other conditions deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walking distance ; | — |
Secondary
| Measure | Time frame |
|---|---|
| WHO functional class of pulmonary hypertension(PH);Borg dyspnea score;Minnesota living with heart failure questionnaire; | — |
Countries
China
Contacts
Public ContactJian Wang
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed