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Jizhi syrup for acute cough due to acute bronchitis(wind-heat syndrome): A prospective, double-blind, placebo-controlled multicentre randomized clinical trial

Jizhi syrup for acute cough due to acute bronchitis(wind-heat syndrome): A prospective, double-blind, placebo-controlled multicentre randomized clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001171
Enrollment
Unknown
Registered
2011-02-02
Start date
2011-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Acute cough due to acute bronchitis

Interventions

Trial group:receive Jizhi syrup orally 3 times a day, 30ml for each time
Control group:receive placebo orally 3 times a day, 30ml for each time

Sponsors

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet with the diagnostic standard of acute cough; (2) Meet with the diagnostic standard of acute bronchitis; (3) Meet with the diagnostic standard of wind-heat cough; (4) The onset time of cough due to acute bronchitis> or = 5 days; (5) The frequency of coughing fits during daytime >10 times; (6) A Bronchitis Severity Score (BSS) > or = 5 score points; (7) Aged 18 to 65 years old; (8) Temperature <38 degree C; (9) agree to participate in randomized controlled trials and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Women during pregnancy or lactation; (2) Patients with allergic constitution or allergic to test drug; (3) Patients with unstable psychiatric disorder or can't cooperation with treatment; (4) Patients with diabetes; (5) Patients with unstable hypertension; (6) Patients with white blood cell count> or = 10*10^9/L; (7) Patients with neutrophil percentage> or =80%; (8) Patients with Lung infection, cancer, tuberculosis judged by chest X-ray; (9) Patients with bronchitis complicated with asthma, acute exacerbation of chronic obstructive pulmonary disease, acute attack of bronchial asthma, interstitial lung disease, cough caused by other diseases; (10) Took other antitussive 3 days before hospitalization; (11) Patients complicated with other serious disease such as congenital heart disease,chronic hepatitis, nephritis, blood diseases, etc; (12) Patients who have life danger during the treatment period.

Design outcomes

Primary

MeasureTime frame
1.remission rate in frequency of coughing fits;2. indication of Jizhi syrup for acute cough due to acute bronchitis;

Secondary

MeasureTime frame
Incidence of pulmonary complications;Traditional Chinese medical four diagnostic symptom score;The change in a visual analogue scale of expectoration relative to baseline on the seventh day;The cure time of cough;The change in cough symptoms score relative to baseline on the seventh day;adverse event;The change in a visual analogue scale of cough relative to baseline on the seventh day;The time of 50% reduction in coughing fits;The change in Bronchitis severity score (BSS) relative to baseline on the seventh day;Reduction in area under curve of coughing fits relative to baseline;The number of patients without cough relative to baseline on the seventh day;The mean reduction in coughing fits on days 5 to 7 relative to baseline;

Countries

China

Contacts

Public ContactZhong Wang
zhonw@vip.sina.com+86 010 64014411-3308

Outcome results

None listed

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