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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)

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)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005979
Enrollment
Unknown
Registered
2022-05-06
Start date
2022-05-09
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough due to bronchiectasis

Interventions

test group :Lily Gujin Tablets + Yangyin Qingfei Pills Simulator
control group :Lily Gujin Tablet Simulator + Yangyin Qingfei Pill

Sponsors

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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 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.

Design outcomes

Primary

MeasureTime frame
Cough VAS Score;

Secondary

MeasureTime frame
LCQ;Cough disappearance/basic disappearance rate;Time for cough to disappear/substantially disappear;Therapeutic effects of TCM syndromes;

Countries

China

Contacts

Public ContactYuguang.Wang
bucmpf@163.com18600375558

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026