Trial of alginates in throat symptoms

Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Patients that have been referred to the Ear, Nose and Throat or Speech and Language Therapy department will be invited to take part in the trial and if interested in taking part will be consented remotely and assessed for eligibility. If patients are deemed eligible they will be randomised via sealed envelope to one of two arms: 1. Gaviscon Advance Arm – 8‐week treatment period – 10 ml administered orally taken four times daily after meals and before bedtime 2. Placebo Arm – 8‐week treatment period ‐ 10 ml administered orally taken four times daily after meals and before bedtime Participants will be sent questionnaires electronically, and report any new medications they may start taking and any adverse events every two weeks. At the end of the treatment period, participants will attend their clinic appointment and complete the final trial questionnaires. CONDITION: Persistent throat symptoms ; Ear, Nose and Throat PRIMARY OUTCOME: Participant‐reported symptoms measured using the Reflux Symptom Index (RSI) questionnaire at the end of 8 weeks of treatment with liquid alginate (Gaviscon Advance) or placebo SECONDARY OUTCOME: ; 1. Participant‐reported symptoms measured using the Reflu XSymptom Inde X(RSI) questionnaire subscales and the Comprehensive Reflu XSymptom Score (CReSS) questionnaire at the end of 8 weeks of treatment with liquid alginate or placebo; 2. Participant‐reported symptoms measured using the RSI questionnaire with and without heartburn at 2, 4 and 6 weeks of treatment with liquid alginate or placebo; 3. Patient‐reported trial medication compliance measured by counting patient‐reported medication levels at the end of 8 weeks of trial treatment; 4. Participant view of trial treatment received measured by the direct question at the end of 8 weeks of trial treatment; 5. Participant‐reported satisfaction with the trial measured by direct question and satisfaction questionnaire at the end of 8 weeks of trial treatment; INCLUSION CRITERIA: 1. Aged 18 years old and over 2. = 6‐week history of persistent throat symptoms (hoarse voice, lump in throat sensation, throat clearing, cough, post‐nasal secretions/catarrh, throat discomfort) as evidenced by a total RSI score omitting the ninth item (heartburn symptoms [HB] “heartburn, chest pain, indigestion or stomach acid coming up” – i.e., RSI – HB) = 13 3. Ability to comprehend trial information and complete trial questionnaires 4. Willing and able to provide informed consent prior to any trial procedures taking place
Epistemonikos ID: 86c523e5767d5d58e7516a09d814b67ea839bb7e
First added on: Aug 26, 2024