Investigating the effectiveness of herbal syrup in improving adult patients with chronic and subacute cough

Phase 3

Recruiting

Conditions: Chronic cough.
Cough

Registration Number: IRCT20240703062321N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Adults aged 18-80 years
Visiting a physician for unexplained cough (ie, no associated diagnosis) or persistent cough (eg, cough that has persisted after treatment for associated diagnoses of asthma, rhinitis, gastroesophageal reflux disease, use of angiotensin-converting enzyme inhibitors)
Informed consent

Exclusion Criteria

Allergy to eucalyptus, thyme, Mallow, green tea, Hollyhocks, ginger, hyssop, Echinacea angustifolia, garlic, Marrubium and peppermint
Cough with infectious sputum
Pregnancy/breastfeeding
Significant mental or neurological disorder
Patients with the possibility of surgery in the next two weeks
Patients with a history of gastrointestinal bleeding
Diabetic patients with uncontrollable blood sugar in the last three months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is cough-related quality of life at 20 days after randomization. The validated score of the Leicester cough questionnaire will be used to evaluate the effect of the drug on the patients' quality of life (the mean difference between the arms measured 20 days after randomization). Total LCQ points will be calculated. The LCQ is also suitable for recording longitudinal improvements in cough and cough-related recovery. Timepoint: Baseline, third and twentieth days. Method of measurement: Leicester Cough Questionnaire (LCQ).

Secondary Outcome Measures

Name	Time	Method
Cough-related quality of life with LCQ score. The sub-domains of quality of life related to physical, psychological and social cough. Total cessation of cough on the third and twentieth days after starting treatment with medicine or placebo. Incidence of re-visit to physician and/or hospitalization for possible worsening of disease and occurrence of adverse events within 20 days after randomization. Incidence of adverse events within 20 days after randomization. Timepoint: Baseline, third and twentieth days. Method of measurement: Leicester Cough Questionnaire.