A Novel, Duodenal-Release Formulation of a Combination of Caraway Oil and L-Menthol for the Treatment of Functional Dyspepsia: A Randomized Controlled Trial.

At 24 hours, the active arm reported a statistically significant reduction in postprandial distress syndrome symptoms ( P = 0.039), and a nonsignificant trend toward benefit of epigastric pain syndrome symptoms ( P = 0.074).

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These differences were statistically significant for patients with epigastric pain syndrome ( P = 0.046), and trending toward significance for patients with postprandial distress syndrome ( P = 0.091).

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After 2–14 days and 15–28 days, patients in the ITT population receiving COLM-SST experienced a greater reduction in symptoms from sensations of pressure, heaviness, and fullness compared with the placebo group, although these changes did not reach statistical significance (for GOS scores, percent changes, and P -values, Table 2 ).

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