The efficacy and safety of Ojeok-san plus Saengmaek-san for gastro-esophageal reflux-induced chronic cough: a protocol for a pilot, randomized, double-blind, placebo-controlled trial
Abstract
Background Gastro-esophageal reflux disease (GERD) is a major cause of chronic cough. GERD-induced chronic cough is difficult to diagnose because some patients do not complain of any gastrointestinal (GI) reflux symptoms. Although chronic cough due to GERD is highly prevalent, no effective treatment is currently available, especially for GERD-related cough without GI symptoms. As the herbal medicines Ojeok-san and Saengmaek-san can effectively treat GERD and cough, we aim to evaluate the efficacy and safety of a combination of these components for relieving chronic cough due to GERD. Methods This is a study protocol of a randomized, double-blind, placebo-controlled, single-center pilot trial. After one-week run-in period, a total of 30 patients with GERD-induced chronic cough will be randomly allocated to an intervention group (n=15) or placebo group (n=15). Participants will receive 5.76 g of Ojeok-san plus Saengmaek-san or a placebo three times per day for 6 weeks. The primary outcome measures, the frequency and severity of cough, will be recorded using a cough diary. The secondary outcome measures will include a cough visual analog scale, the Leicester Cough Questionnaire (Korean version), Gastrointestinal Symptom Rating Scale, Hull Airway Reflux (hypersensitivity) Questionnaire, Pattern Identification for Chronic Cough Questionnaire, Pattern Identification for Gastroesophageal Reflux Disease, and safety testing. Adverse events will also be reported. Discussion This will…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30 participants or records.
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