Evaluating the Efficacy of Carum Copticum Seeds on the Treatment of Patients with Nonalcoholic Fatty Liver Disease: A Multi-Center, Randomized, Triple–Blind, Placebo-Controlled Clinical Trial Study

Background: The increased prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) has caused several concerns. Besides, there are concerns about the side effects of the drugs used to treat this condition. Since the current treatments are not effective in treating NAFLD, developing a novel therapeutic option based on some medicinal plants is necessary. Few studies have investigated the natural drugs and their effects (e.g., extracts of Carum Copticum Seeds (CCS)) on these patients. Objectives: The current study intended to evaluate the safety and efficacy of CCS extracts on liver enzymes, serum lipids, as well as the grade of fatty liver, and anthropometric measurements in patients with nonalcoholic fatty liver disease. Methods: In this multi-center, randomized, triple-blind, placebo-controlled clinical trial study, 90 patients with grades of 1 to 3 of nonalcoholic fatty liver disease referred to two medical centers located in Tehran (Iran) in 2019 are examined. Diet and exercise were recommended for patients three times a day in eight weeks, in addition to taking 500 mg capsules (aqueous extracts of Ajwain seeds and placebo for treatment and placebo groups). Results: Medical records of 68 patients were reviewed, 48 (71%) male and 20 (29%) female. Both groups were similar concerning demographic and baseline characteristics. The total score of the Leeds questionnaire [-14.03 vs. -7.49, P = 0.048], Triglyceride (TG) [-4.45 vs. 10.03, P = 0.017], and Alanine Aminotransferase (ALT) [-14.71 vs. -4.79, P = 0.012] were significantly changed in the treatment group compared to the control group. Nevertheless, a different situation was observed for Aspartate Aminotransferase (AST) [-7.08 vs. -4.84, P = 0.314], Fasting Blood Sugar (FBS) [-2.88 vs. -2.81, P = 0.207], and Body Mass Index (BMI) [-0.59 vs. -0.39, P = 0.095]. Although a significant change was found in both groups, the amount of decline was similar for both groups. In both groups, the cholesterol, High-Density Lipoprotein (HDL), and Low-Density Lipoprotein (LDL) did not change significantly. The sonographic findings indicated significantly higher improvements in the intervention group than the placebo group (RR = 2.43, 95% CI (1.15-5.65), and P value = 0.034). Conclusions: The result of this study supports the efficacy of Carum copticum seeds in the treatment of nonalcoholic fatty liver disease patients. It was found that CCS with a significant reduction in ALT, TG, and relative reduction of BMI can help physicians to manage other metabolic disorders associated with NAFLD, such as obesity and hyperlipidemia.