Randomized, double-blind, positive drug parallel control, multi-center Chinese medicine variety protection clinical trial on the efficacy and safety of Baihe Gujin tablet in the treatment of post-cold cough (lung-kidney yin deficiency syndrome).
- Conditions
- cough after a cold
- Registration Number
- ITMCTR2200006021
- 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 post-cold cough in the Guidelines for Diagnosis and Treatment of Cough (2015);
(2) Comply with the standard of TCM syndrome differentiation of lung and kidney yin deficiency;
(3) When visiting a doctor, the daytime or nighttime cough score is =2 points, and the cough VAS score is more than 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) Cough variant asthma (CVA), upper airway cough syndrome (UACS), eosinophilic bronchitis (EB), gastroesophageal reflux cough (GERC), chronic bronchitis, chronic obstructive pulmonary disease Patients with subacute or chronic cough caused by diseases and other causes;
(2) ALT and/or AST >1.5 upper limit of normal reference value; serum creatinine > upper limit of normal reference value; blood leukocyte <3.0×109/L or >10.0×109/L; and/or neutrophil (N) classification >80%; body temperature =37.3?;
(3) Patients taking angiotensin-converting enzyme inhibitors (ACEI);
(4) within 24 hours of taking drugs that cause adverse reactions to cough, or receiving drugs and non-drug treatments with antitussive, phlegm-relieving, and spasmolytic effects;
(5) Combined with serious primary diseases of cardiovascular and cerebrovascular, liver, kidney, respiratory system, circulatory system, autoimmune system and hematopoietic system, or serious diseases that affect their survival, such as tumor or AIDS; of disabled patients; abnormal chest X-ray, not excluding inflammation or space-occupying lesions;
(6) A history of alcohol and drug abuse or drug use in the past year;
(7) 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;
(8) Participated in another drug study within three months prior to enrollment;
(9) Those with allergic constitution or known ingredients of the drug;
(10) The investigator determines that there are other factors that are not suitable for inclusion.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cough VAS Score;
- Secondary Outcome Measures
Name Time Method CQ;Therapeutic effects of TCM syndromes;Cough disappearance/basic disappearance rate;Time for cough to disappear/substantially disappear;Therapeutic effect of TCM single symptom;