A Clinical study to evaluate efficacy of CaFi (Branded ingredient of Cassia Fistula Extract) in the healthy individuals having Irregular bowel habits-An Open Label, Randomized, Comparative, Multi centric, Interventional, Prospective, Clinical Study.

BackgroundIrregular bowel habits including constipation are common gastrointestinal issues, significantly impacting quality of life. While conventional pharmacological treatments exist, they often come with side effects and offer limited long-term relief, driving interest towards safer, effective herbal alternatives. Cassia fistula (C. fistula) has long been recognized for its laxative properties and has been reported to be a safer alternative to Senna (Cassia angustifolia). PurposeThis study aimed to evaluate the efficacy and safety of a standardized extract of C. fistula compared to Senna extract in healthy individuals experiencing irregular bowel habits. MethodsA two-arm, open-label, randomized, multicentric, interventional, prospective clinical study was conducted in India with 70 participants (35 per group). One group received the standardized C. fistula extract and the other group received Senna extract for 14 days, followed by a 7-day post-consumption follow-up. Primary outcomes included changes in bowel movement frequency. Secondary outcomes assessed stool consistency (Bristol Stool Form Scale), straining, bowel satisfaction after defecation, anorectal blockage, use of manual manoeuvres, average time spent on defecation, time to first bowel evacuation post intervention and associated clinical symptoms (headache, belching, flatulence, abdominal distension, acidity). Safety was evaluated through vitals, laboratory parameters, and adverse events. ResultsC. fistula extract significantly increased bowel movement frequency (3.30 {+/-} 0.92 to 5.90 {+/-} 1.24 at Day 14, p<0.05) and improved stool consistency comparable to Senna extract. Straining and bowel satisfaction after defecation also significantly improved with the use of C. Fistula. Notably, C. fistula extract showed significantly greater reduction in the sensation of anorectal blockage at Days 14 and 21 (p<0.05) and a faster onset of action (shorter time to first defecation) compared to Senna. Associated symptoms of constipation also reduced significantly. C. fistula extract was better well-tolerated, with fewer product-related adverse events compared to Senna. ConclusionC. fistula extract was found to be effective in irregular bowel habits, offering comparable efficacy to Senna while proving to be superior in reducing the sensation of anorectal blockage and achieving a faster time to first bowel evacuation. It also demonstrated a more favorable safety profile with significantly fewer product-related adverse events. Therefore, C. fistula extract represents a promising non-habit-forming herbal alternative for bowel regulation.