Real-World evaluation of an OTC cough medicine containing diphenhydramine.
Research type
Research Study
Full title
A real world, single-blind, randomised study to compare an OTC cough medicine (cs1002) containing diphenhydramine, levomenthol and ammonium chloride with a simple linctus containing citric acid monohydrate in terms of daily cough severity in subjects with acute cough in routine clinical practice.
IRAS ID
165988
Contact name
Surrinder Birring
Contact email
Sponsor organisation
infirst HEALTHCARE
Eudract number
2014-004255-31
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
This study aims to compare the real-world effectiveness of an Over-The-Counter cough medication containing an antihistamine (diphenhydramine), a decongestant (levomenthol) and an expectorant (ammonium chloride)with a simple linctus (Bells' Simple Linctus containing citric acid monohydrate)currently recommended by healthcare professionals for the relief of acute cough. There are a large number of cough treatments available and the efficacy of many of them has been questioned. However there is evidence to support the efficacy of diphenhydramine as an anti-tussive so this study is intended to evaluate the efficacy of the combination product in comparison with the simple linctus using validated assessment methods in a real-world setting. The study therefore will be undertaken across a number of sites including General Practitioner clinics and Pharmacies.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/1424
Date of REC Opinion
28 Nov 2014
REC opinion
Favourable Opinion