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Efficacy and safety of Xingqinganke granule in the treatment of post-cold cough(Wind-Warm Incubating the Lung): a randomized controlled phase II clinical trial

Efficacy and safety of Xingqinganke granule in the treatment of post-cold cough(Wind-Warm Incubating the Lung): a randomized controlled phase II clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085269
Enrollment
Unknown
Registered
2024-06-04
Start date
2024-02-20
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

post-cold cough

Interventions

control group:Placebo medicine,1 bag/time, 11g/bag, 3 times a day, taken orally after meals
low dose group:10g/bag raw drug contained,1 bag/time, 11g/bag, 3 times a day, taken orally after meals
high dose group:20g/bag raw drug contained, 1 bag/time, 11g/bag, 3 times a day, taken orally after meals

Sponsors

Shuguang Hospital Affiliated to Shanghai University of T.C.M.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) accord with that diagnostic criteria of cough after catch a cold; (2) accord with that diagnostic criteria of wind-heat latent lung syndrome of TCM; (3) The duration of cough was 3-6 weeks; (4) Cough VAS score = 60 mm (0-100 mm scale); (5) The white blood cell count and the percentage of neutrophils were normal in blood routine examination; (6) Age between 18 and 65 years old, regardless of gender; (7) The patient voluntarily signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with other respiratory diseases (such as acute tonsillitis, acute and chronic pharyngitis, upper airway syndrome, acute tracheobronchitis, tracheobronchial tuberculosis, bronchial asthma, chronic obstructive pulmonary disease, cough variant asthma, allergic cough, gastroesophageal reflux cough, eosinophilic bronchitis, lung tumors, acute exacerbation of bronchiectasis, pneumoconiosis, etc.), pleural diseases (such as pleurisy, pneumothorax, etc.) Central nervous system factors (such as encephalitis, meningitis, etc.); cough caused by ACEI drugs, psychological cough, cardiogenic cough and cough caused by other causes; (2) Abnormal eosinophil count and percentage in peripheral blood; (3) Liver and renal function tests: ALT or AST > 1.5 times the upper limit of normal value, or Scrgt the upper limit of normal value; (4) Abnormal blood IgE; (5) Current positive detection of novel coronavirus antigen; (6) Wet rales or wheezing on lung auscultation; (7) Abnormal and clinically significant pulmonary CT examination (pulmonary nodules = 8 mm should be excluded); (8) Abnormal pulmonary function test: positive bronchodilation test (after inhalation of bronchodilator, ? FEV1 > 12% and absolute value increased by > 200 ml compared with baseline value); obstructive pulmonary ventilation dysfunction (FEV1/FVC 32 ppb; (10) Patients with hypertension (moderate or above, systolic blood pressure 160-179 mmHg and/or diastolic blood pressure 100-109 mmHg, including boundary values), severe primary diseases of circulatory system, central nervous system, hematopoietic system, endocrine system, cardiovascular system and other psychiatric patients; (11) allergy to this drug; (12) Pregnant or lactating women; (13) Those who have participated in other clinical trials in the past month; (14) Other conditions considered by the investigator as inappropriate for inclusion.

Design outcomes

Primary

MeasureTime frame
effective rate of cough;The resolution rate of cough;

Secondary

MeasureTime frame
resolution time of cough;The first resolution time of cough;time for cough resolution lasted for 3 days;score of the Leisester Cough Quality of Life Questionnaire (LCQ);Cough TCM symptom score changes;TCM symptom evaluation (including the total effective rate);cough symptom (including daytime/nighttime cough);Patient Global Impression Change Score (PGIC);

Countries

China

Contacts

Public ContactWei Zhang

Shuguang Hospital Affiliated to Shanghai University of T.C.M.

zhangw1190a@sina.com+86 130 2315 3956

Outcome results

None listed

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