Randomized, double-blind, positive-drug parallel-controlled, multi-center clinical trial on the efficacy and safety of Baihe Gujin tablets in the treatment of cough caused by bronchiectasis (lung-kidney yin deficiency syndrome)
- Conditions
- Cough due to bronchiectasis
- Registration Number
- ITMCTR2200005979
- Lead Sponsor
- Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the diagnostic criteria for bronchiectasis in the 2021 Chinese Adult Bronchiectasis Diagnosis and Treatment Expert Consensus;
(2) Comply with the standard of TCM syndrome differentiation of lung and kidney yin deficiency;
(3) Daytime or nighttime cough score = 2 points, cough VAS score > 3 points;
(4) Aged 18 to 65 years old (including 18 and 65 years old), gender is not limited;
(5) Subjects gave informed consent, voluntarily tested and signed the informed consent form.
(1) Post-cold cough, cough variant asthma (CVA), postnasal drip syndrome, upper airway cough syndrome (UACS), eosinophilic bronchitis (EB), gastroesophageal reflux cough (GERC) ), chronic bronchitis, tuberculosis, lung abscess, lung cancer and subacute or chronic cough caused by other etiologies;
(2) Acute exacerbation of bronchiectasis;
(3) 24-hour hemoptysis >100ml or 1 episode of hemoptysis >50ml within 6 months;
(4) ALT and/or AST >1.5 upper limit of normal reference value; serum creatinine > upper limit of normal reference value; blood white blood cell <3.0×109/L or >10.0×109/L; and/or neutrophil (N) classification >80%; body temperature (underarm) =37.3?;
(5) Patients who have smoked or quit smoking for less than three months; or are inevitably exposed to dust or harmful gases for a long time;
(6) Taking drugs that cause adverse reactions to cough within 24 hours;
(7) Traditional Chinese medicines or proprietary Chinese medicines with the functions of nourishing yin and moistening the lungs, resolving phlegm and relieving cough have been used within 1 week;
(8) Combining serious primary diseases of cardiovascular and cerebrovascular, liver, kidney, respiratory system, circulatory system, autoimmune system and hematopoietic system, or serious diseases affecting their survival, such as tumor or AIDS; of disabled patients;
(9) History of alcohol and drug abuse or drug use in the past year;
(10) Pregnant or lactating women or those who are unwilling to take contraceptive measures during the test and within 1 month after the end of the test;
(11) Participated in another drug study within three months before enrollment;
(12) Those with allergic constitution or known ingredients of the drug;
The investigators determined that there were other factors that were inappropriate for enrollment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cough VAS Score;
- Secondary Outcome Measures
Name Time Method CQ;Cough disappearance/basic disappearance rate;Time for cough to disappear/substantially disappear;Therapeutic effects of TCM syndromes;