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A randomized, double-blind, placebo-controlled, multicenter clinical study of Lianhua Qingke Tablet in the treatment of cough after COVID-19 infection

A randomized, double-blind, placebo-controlled, multicenter clinical study of Lianhua Qingke Tablet in the treatment of cough after COVID-19 infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068877
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

cough

Interventions

Lianhua Qingke Tablet Group:Lianhua Qingke Tablets, 4 tablets/time, 3 times a day
Placebo control group:Lianhua Qingke tablet placebo, 4 tablets/time, 3 times a day

Sponsors

BEIJING HOSPITAL OF TRADITIONAL CHINESE MEDICINE
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. It meets the western diagnostic criteria for cough after COVID-19 infection; 2. The age is 18-65 years old; 3. The duration of cough after COVID-19 infection was 3 to 8 weeks; 4. Cough VAS score >= 40mm (0-100mm scale); 5. Subjects voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who meet the diagnosis of acute cough, drug-induced cough, allergic cough, cough variant asthma, upper airway cough syndrome, eosinophilic bronchitis, gastroesophageal reflux cough; 2. Cough patients caused by chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, lung abscess, interstitial lung disease (including severe pulmonary fibrosis after COVID-19 infection), lung cancer, bronchiolitis, bronchopneumonia and other diseases; 3. Chronic rhinitis, sinusitis, pharyngitis, allergic rhinitis, allergic rhinitis and other nasopharyngeal diseases; 4. Serious cardiovascular, cerebrovascular, digestive system, endocrine system, nervous system, mental system diseases or other diseases; 5. Those with body temperature > 37.3 ?; 6. Increase of white blood cell count>12 × 10 ^ 9/L, suspected of bacterial infection; 7. Liver function damage (ALT or AST >= 1.5 times the upper limit of normal value), renal insufficiency (Cr>the upper limit of normal value); 8. Patients who have taken traditional Chinese medicine for relieving cough and resolving phlegm with similar functions and indications as the test drug in the past 3days; 9. Allergic constitution (allergic to more than 2 substances), or allergic to the test drug or its components; 10. Alcoholism and/or drug abuse within 1 year before the test; 11. Pregnant, lactating women, those who plan to become pregnant or cannot use reliable contraceptive measures; 12. Participate in other interventional clinical studies that may affect the results of this study; 13. Other researchers think it is not suitable for this test.

Design outcomes

Primary

MeasureTime frame
Time of cough disappearance within 14 days;

Secondary

MeasureTime frame
The disappearance rate of cough within 14 days;Remission rate and duration of cough within 14 days;Change value and change rate of total score of cough symptoms after 7 and 14 days of infection;Change value and change rate of cough visual analogue (VAS) score at 7 and 14 days;The change value and change rate of the total score of cough severity at 7 and 14 days from the baseline;

Countries

China

Contacts

Public ContactLiu Qingquan

BEIJING HOSPITAL OF TRADITIONAL CHINESE MEDICINE

liuqingquan2003@126.com+86 139 1005 5687

Outcome results

None listed

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