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

Preparation of herbal syrup formulation (Fran), and its effectiveness in improving adult patients with chronic and subacute cough

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240703062321N1
Enrollment
120
Registered
2024-07-11
Start date
2024-07-21
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Chronic cough. Cough

Interventions

Intervention 1: Intervention group: Patients in the intervention group will consume 5 cc every 8 hours of a herbal syrup (Fran) containing eucalyptus, thyme, Mallow, green tea, Hollyhocks, ginger, hys

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
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.

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahnaz Khanavi

Tehran University of Medical Sciences

khanavim@tums.ac.ir+98 21 6412 0448

Outcome results

None listed

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