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A randomized double-blind placebo-controlled multicenter phase ? clinical trial was conducted to investigate the efficacy and safety of Xingbei Zhike granules in the treatment of post-infectious cough (wind-heat invading lung)

A randomized double-blind placebo-controlled multicenter phase ? clinical trial was conducted to investigate the efficacy and safety of Xingbei Zhike granules in the treatment of post-infectious cough (wind-heat invading lung)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000644
Enrollment
Unknown
Registered
2024-11-03
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Post-infectious cough

Interventions

Treatment group:Xingbei Zhike granules
Placebo group:Xingbei Zhike granules mimics agent

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) The patient met the diagnostic criteria for post-infectious cough; (2) The patient met the diagnostic criteria for the wind-heat invading lung TCM syndrome; (3) The duration of cough ranged from 3 to 5 weeks; (4) The cough VAS score=60mm; (5) Patients of both sexes were between 18 and 65 years of age (both ends included); (6) Patients gave informed consent and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of cough-related chronic lung disease including but not limited to gastroesophageal reflux disease bronchial asthma or cough variant asthma or chest tight-type asthma eosinophilic bronchitis acute or chronic sinusitis bronchial tuberculosis interstitial lung disease chronic bronchitis bronchiectasis chronic obstructive pulmonary disease bronchial lung cancer etc; (2) Patients with severe primary diseases of cardiovascular cerebrovascular liver kidney or hematopoietic system or with known immunocompromised or immunodeficiency diseases; (3) Patients with FeNO=32 ppb; (4) Patients with axillary temperature =37.3? or white blood cell count > 12×10^9/L and neutrophil percentage > 75%; (5) Patients whose serum Cr exceeded the upper limit of the reference value or patients with either ALT or AST exceeding 1.5 times the upper limit of the reference value; (6) Patients who quit smoking for less than 3 months; (7) Patients with suspected or confirmed history of alcohol or drug abuse or patients with cognitive impairment or severe mental illness who cannot cooperate with the completion of the clinical trial; (8) Women who are pregnant or planning to become pregnant within six months and lactating women; (9)Allergic patients such as those with a history of allergy to two or more drugs or foods or those who are known to be allergic to the ingredients of the drug used in the study; (10) Participants who had participated in any clinical trial within 3 months before the screening examination; (11) Patients who were judged by the investigator to be ineligible to participate in the trial.

Design outcomes

Secondary

MeasureTime frame
The number and frequency of emergency medication use;The changes of cough evaluation test(CET) score on days 7 and 14 were compared with baseline;Change from baseline in Leichester Cough Quality of Life Questionnaire (LCQ) score;Changes in TCM syndrome scores from baseline to 7 days and 14 days after treatment;Changes in cough VAS scores from baseline to 7 days and 14 days;The disappearance time and rate of cough symptoms after treatment;

Countries

China

Contacts

Public ContactLinLin

Guangdong Provincial Hospital of Traditional Chinese Medicine

drlinlin620@163.com13903002015

Outcome results

None listed

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