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Efficacy and Safety of Shufeng Huashi Formula for Post-Infectious Cough: A Randomized Double-Blind Placebo-Controlled Parallel Clinical Trial

Efficacy and Safety of Shufeng Huashi Formula for Post-Infectious Cough: A Randomized Double-Blind Placebo-Controlled Parallel Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001210
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-11-04
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

post-infectious cough

Interventions

Control Group :Placebo (Shufeng Huashi Granules Simulant)
Treatment Group :Shufeng Huashi Granules

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Aged between 18 and 65 years (inclusive) at the time of signing the informed consent form; (2)Diagnosed with post-infectious cough according to Western medicine diagnostic criteria; (3)Identified as having the Traditional Chinese Medicine (TCM) syndrome of wind exuberance and dampness obstruction; (4)Cough symptom score = 3 points; (5)Voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Cough caused by other etiologies, such as cough variant asthma (CVA), upper airway cough syndrome (UACS), eosinophilic bronchitis (EB), gastroesophageal reflux-related cough (GERC), allergic cough (AC), chronic bronchitis, etc., as well as persistent cough symptoms prior to this infection; (2) Participants with severe pulmonary diseases (e.g., chronic obstructive pulmonary disease, lung cancer, tuberculosis); (3) Participants who have taken angiotensin-converting enzyme inhibitors (ACEI) within the past month; (4) Current smokers or those who have quit smoking for less than 3 months; (5) Participants with severe cardiovascular, cerebrovascular, malignant tumor, hematological, gastrointestinal, or other systemic diseases, or severe or progressive diseases; or those with severe mental disorders, severe cognitive impairment, etc., who are unable or unwilling to cooperate; (6) Participants with impaired liver or kidney function: ALT or AST > 2 times the upper limit of normal reference values; and/or serum creatinine > 1.5 times the upper limit of normal reference values; (7) Participants with white blood cell count 10.0×109/L; and/or neutrophil (N) classification > 80%; (8) Participants with body temperature (axillary) = 37.3?; (9) Participants with allergic constitution (allergic to 2 or more substances) or allergy to the investigational drug or its components; (10) Participants with a history of long-term alcohol abuse or drug addiction; (11) Pregnant, breastfeeding women, or women planning pregnancy; (12) Participants who have received or are currently receiving other drug clinical trials within the past 3 months; (13) Participants deemed unsuitable for participation by the investigator (e.g., poor compliance).

Design outcomes

Primary

MeasureTime frame
Cough Relief Rate;

Secondary

MeasureTime frame
Cough Symptom Score;Simplified Cough Severity Score;TCM Syndrome Efficacy;Leicester Cough Questionnaire (LCQ) Score;Cough Relief Rate;Cough cure rate;Time to Cough Resolution;Time to Cough Alleviation;Cough Recurrence Rate;

Countries

China

Contacts

Public ContactZhang Hongchun

China-Japan Friendship Hospital

13701226664@139.com13701226664

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 3, 2026