The efficacy of Ramak (a traditional herbal medicine preparation) for patients with ulcerative colitis: A pilot, randomized, triple-blinded, placebo-controlled clinical trial

Introduction: Ulcerative colitis (UC) is a common chronic inflammatory disease. Although the current medication can greatly help to control the disease, the complications of these drugs have led to complementary treatments being taken into consideration. Ramak is a compound herbal preparation that is traditionally used in Persian medicine for intestinal ulcers and chronic diarrhea. Therefore, a clinical trial was conducted to evaluate the efficacy of Ramak, as a complementary treatment, for the management of UC. Methods: Forty patients with UC were randomly allocated to either Ramak or placebo capsules (250mg, once a day) for 10 weeks. Patients in both groups also received conventional treatment. The Simple Clinical Colitis Activity Index (SCCAI) was the primary outcome measure. Also, withinand between group comparisons were made based on 6 different items of SCCAI. Results: There was a significant between group difference regarding SCCAI total scores at 4th, 6th, 8th, and 10th weeks (p < 0.05). Also, the time course showed stability of SCCAI total score in the Ramak group (p = 0.20). In addition, a significant difference was shown regarding the urgency of defecation and general health scores of the Ramak group vs. the control group (p < 0.001 and p = 0.03, respectively). Conclusion: It appeared that complementary treatment with Ramak may prevent symptom aggravation. Moreover, Ramak improved defecation urgency. However, further clinical trials with a larger cohort and longer intervention time are warranted for better decision making in clinical practice.