Skip to content

A multicenter, prospective, cluster randomized controlled trial on the efficacy and safety of golden orange drink in the treatment of post-infection cough

A multicenter, prospective, cluster randomized controlled trial on the efficacy and safety of golden orange drink in the treatment of post-infection cough

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002103
Enrollment
Unknown
Registered
2025-11-04
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Post-infection cough

Interventions

Treatment group: ?Kumquat decoction
Control group:conventional treatment

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Presence of persistent cough during the convalescent phase of an acute upper respiratory tract infection, meeting the Western medicine diagnostic criteria for post-infectious cough (a) A clear history of respiratory tract infection at the onset, with acute catarrhal symptoms of a common cold such as rhinorrhea, sneezing, fever, headache, sore throat, or cough; (b) After the resolution of the acute catarrhal symptoms, the cough persists or even worsens, typically presenting as paroxysmal, irritating dry cough or with expectoration of a small amount of white mucoid phlegm, and the duration usually lasts for 3 to 8 weeks; (c) No abnormal rales detected upon lung auscultation; (d) Other causes of cough have been excluded. Age between 18 and 85 years (inclusive). The patient or their legal guardian has provided written informed consent.

Exclusion criteria

Exclusion criteria: Individuals with allergic constitution or those allergic to any components of the cough relief patch. Patients with chronic pulmonary diseases that may interfere with the assessment of cough symptoms, such as bronchiectasis, bronchopneumonia, chronic lung abscess, chronic cough lasting more than 8 weeks, chronic pharyngitis with cough, lung cancer, or bacterial respiratory infections. Heavy smokers (smoking index =400, calculated as pack-years smoked* or years smoked × cigarettes per day =400, e.g., smoking history =20 years and =20 cigarettes per day). Patients with severe underlying diseases or acute exacerbation of chronic conditions (e.g., acute heart failure), or those with acute cough caused by other critical illnesses such as acute myocardial infarction, left ventricular dysfunction, pulmonary embolism, or foreign body aspiration. Pregnant female subjects. Individuals with poor compliance who are unable to cooperate and complete the study. Participants who have been involved in another clinical trial within one month prior to this study or are currently participating in another clinical trial. Patients with incomplete data that would affect the judgment of efficacy.

Design outcomes

Primary

MeasureTime frame
time to cough symptom resolution;

Secondary

MeasureTime frame
The percentage of patients with resolved cough symptoms on day 3 and day 5 after treatment.;Change from baseline in Cough Evaluation Test (CET) score at day 3 and day 5 after treatment;Change from baseline in cough Numeric Rating Scale (NRS) score at day 3 and day 5 after treatment;Change from baseline in Leicester Cough Questionnaire (LCQ) score at day 3 and day 5 after treatment;

Countries

China

Contacts

Public ContactZhongde Zhang

Guangdong Provincial Hospital of Chinese Medicine

doctorzzd99@163.com18602010082

Outcome results

None listed

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