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Clinical Trials/ITMCTR2200005979
ITMCTR2200005979
Not yet recruiting
Phase 4

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)

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University0 sitesTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Cough due to bronchiectasis
Sponsor
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
All

Investigators

Sponsor
Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

Eligibility Criteria

Inclusion Criteria

  • (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.

Exclusion Criteria

  • (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;

Outcomes

Primary Outcomes

Not specified

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