Safety and efficacy of a novel phytoceutical formulation CL18100F4 in increasing gut motility and improving stool...

Constipation and gastrointestinal (GI) dysmotility are prevalent disorders often associated with impaired gut-brain axis regulation and limited therapeutic options. This study investigated the safety and gastrokinetic efficacy of CL18100F4 (Digexin^®), a standardized polyherbal formulation comprising extracts of Withania somnifera (Ashwagandha) root and Abelmoschus esculentus (Okra) pods. Ex vivo assays using isolated rat ileum demonstrated that CL18100F4 significantly enhanced intestinal contractility in a dose-dependent manner, with muscarinic receptor involvement confirmed by atropine inhibition. In vivo administration of CL18100F4 (200- and 300 mg/kg body weight for eight days) to Wistar rats showed significant improvements in gastric emptying (73.97 ± 15.12%, p = 0.0410), intestinal transit (80.43 ± 4.76%, p = 0.0184), and fecal moisture content (57.42 ± 5.05%, p = 0.0101), without affecting fecal pellet count. Serum corticosterone levels were significantly reduced, while serotonin levels increased, suggesting modulation of the gut-brain axis. No adverse alterations were observed in liver, kidney, or metabolic biochemical parameters, indicating systemic safety. Collectively, these findings demonstrate that CL18100F4 exerts synergistic gastrokinetic and neuroendocrine regulatory effects while maintaining a good safety profile. The formulation shows promise as a functional food or nutraceutical for managing GI motility disorders by modulating the gut-brain axis-associated biomarkers.