Effect of an Herbal Product on the Serum Level of Liver Enzymes in Patients with Non-Alcoholic Fatty Liver Disease: A Randomized, Double-Blinded, Placebo-Controlled Trial

Background: Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease. There is no definitive treatment for this, and prevention and treatment via diet and weight loss have been recommended. Objectives: This study aimed to investigate the effect of Dava Al-Balgham, as one of the traditional medicine products, in patients with NAFLD. Methods: The study was a randomized, double-blinded, placebo-controlled trial performed among 76 patients with NAFLD in a university-affiliated hospital, Qom, Iran, in 2017. The individuals were assigned into two groups of intervention (receiving Dava Al-Balgham; n = 37) and placebo (n = 39), using the randomized block allocation method. Both groups maintained the same diet and lifestyle. In the intervention group, two tablets of Dava Al-Balgham (a combination of Nigella sativa, Zataria multiflora, Pistacia lentiscus, and Trachyspermum ammi) were consumed with each meal for three months. In the other group, placebo tablets were used in the same manner. Pre- and post-intervention weight, waist circumference, and liver enzyme levels were measured. Chi-square, t-test, and analysis of covariance were used for comparing the two groups. Results: The levels of liver enzymes, weight, and waist circumference decreased in both groups. The mean reduction in alanine transaminase (ALT) in the intervention group was 22.80, while it was 1.59 in the placebo group (P = 0.008). The mean weight loss in the intervention and placebo groups was 2.69 kg and 0.9 kg, respectively (P = 0.003). Moreover, the mean reduction in waist circumference in the intervention and placebo groups was 3.43 cm and 0.33 cm, respectively (P = 0.001). Conclusions: Dava Al-Balgham tablets with the weight loss and hypolipidemic effect of its components can be used to help the prevention and treatment of NAFLD.