Effect of herbal formula based on rosa damascena on functional bloating severity in older adults: a pilot double-blind randomized controlled trial.

INTRODUCTION: This study explores the efficacy and tolerability of an herbal formula, based on Rosa damascena (an oral syrup) carminative properties, rooted in Traditional Persian Medicine in the management of functional bloating. It aims to evaluate its efficacy in reducing bloating severity among older adults, integrating traditional and modern therapeutic approaches. METHODS: In this double-blind, randomized controlled trial, 72 participants aged 60 years and older with functional bloating were randomly assigned to receive either herbal syrup or a placebo, twice daily for 4 weeks. The primary outcome was bloating severity score, measured using the Gastrointestinal Symptom Rating Scale (GSRS). .(1). Acid reflux severity, constipation severity and defecation frequency were secondary outcome measures. Both outcomes were assessed at baseline and weekly during the study period (days 7, 14, 21, and 28) through in-person and telephone interviews. Data analysis was conducted using SPSS version 26. RESULTS: 60 participants completed it (32 in the herbal group and 28 in the placebo group). At baseline, there was no significant difference in the bloating severity between the intervention and placebo groups (P = 0.722). After one week, the intervention group showed a significantly lower bloating severity compared to the placebo group (P = 0.002), and this difference became even more pronounced by the end of the fourth week (P < 0.001). Furthermore, the Defecation Frequency Rate (DFR) significantly improved in the intervention group compared with the placebo group after the study (P < 0.001). CONCLUSION: The herbal formula appears to be an effective and well-tolerated therapeutic option for managing functional bloating in older adults. Significant improvements in bloating and defecation were observed throughout the study.