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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).

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).

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2200006021
Enrollment
Unknown
Registered
2022-05-20
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 after a cold

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 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.

Exclusion criteria

Exclusion criteria: (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 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.

Design outcomes

Primary

MeasureTime frame
Cough VAS Score;

Secondary

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

Countries

China

Contacts

Public ContactYuguang.Wang
bucmpf@163.com18600375558

Outcome results

None listed

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