Efficacy of Jawarish Shahi a herbal formulation in irritable bowel syndrome: An open-labeled single-arm clinical trial

BACKGROUND AND AIM: Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders characterized by chronic recurrent abdominal pain related to a change in bowel habit or defecation frequency and commonly accompanied by anxiety and depression affecting about 10% population globally. Jawarish Shahi (JS) is a special dosage form prepared for gastrointestinal disorders in Unani medicine containing Phyllanthus emblica L., Terminalia chebula Retz., Coriandrum sativum L., Elettaria cardamomum (L.) Maton and Salix caprea L. Considering the antioxidant, immunomodulatory, antispasmodic analgesic, antidiarrheal, antisecretory, laxative, anti-inflammatory, anxiolytic, and antidepressant properties, the present study was aimed to evaluate the efficacy of JS in IBS. EXPERIMENTAL PROCEDURE: This single-arm open-labeled clinical trial was conducted on 26 male and female patients of IBS according to Rome IV criteria, aged 18–50 years with moderate symptoms. JS was given 7 g orally twice a day after meal with water for 45 days. IBS Severity Scoring Scale (IBS-SSS) was used for efficacy outcomes and the difference was analyzed from baseline to the subsequent follow-ups. RESULTS: Data analysis of subsequent followup showed a significant decrease in IBS-SSS scores except for 2nd followup, scores decreased from 229.50 ± 75.91 to 203.12 ± 71.71 (p < 0.1018), 150.61 ± 55.32 (p < 0.0001), and 123.76 ± 54.81 (p < 0.0001) at 0, 15th, 30th, 45th day of follow up respectively. CONCLUSION: The present study revealed that JS is safe and effective in reducing the overall symptoms of IBS in respect to its severity and impact on quality of life and can be used as an alternate as well as a complementary treatment in IBS.