An Open-label Prospective Study to Assess the Effectiveness, Tolerability, and Safety of <i>Ayurvedic</i> Intervention (<i>Kutajarishta</i>) in the Treatment of Irritable Bowel Syndrome

Background: Irritable Bowel Syndrome (IBS) is a major health problem that impacts around 15% of the world’s population. IBS has a detrimental impact on one’s quality of life and might lead to missed school or a job. Modern medicine for the treatment of IBS symptoms is still limited in clinical practices due to side effects, high relapse rates, and the appearance of being ineffective in enhancing IBS patients’ quality of life. As a result, there is a clear need to explore more potent and comprehensive treatments for this disease. Several herbal medicines in the Ayurvedic school of medicine can fill this vacuum. Aim: To explore the therapeutic effectiveness, tolerability and safety of Kutajarishta in the treatment of IBS. Methods: The current trial included 180 confirmed cases of irritable bowel syndrome of subtype mixed (IBS-M) who met the diagnostic criteria as specified by the Rome III criteria, regardless of their gender, religion, or socioeconomic background. Kutajarishta was administered 25 ml twice a day orally with an equal amount of water. Routine haematological and biochemistry tests, subjective parameters, IBS severity score, and WHO-QOL BREF score were periodically examined to determine the efficacy and safety of Kutajarishta during the 98-day study (including a two-week follow-up without medication). Results: The trial drug Kutjarishta confirmed statistically significant enhancement in the clinical manifestations along with elevation in the WHO QOL BREF score and a reduction in the IBS severity score. There was no impairment in renal function tests and liver function, suggesting that trial therapy has an excellent safety profile. Conclusion: Kutajarishta is found to be safe, tolerable, and an effective remedy in the treatment of IBS. Major Findings: In this clinical evaluation of 25ml of Kutjarishta twice daily was found effective in relieving the cardinal features of IBS, along with a reduction in IBS severity score and elevation in the WHO-QOL BREF Score.