Abstract
The prevalence of NAFLD is persistently escalating (15% in 2005 to 25% in 2010). The current outbreak in chronic liver disease is linked to the load of Nonalcoholic fatty liver disease (NAFLD).According to Ayurvedic perspective, NAFLD may be recognized as Yakṛuta Rog (~liver disease). Yakrut-dalaudar is comprehensive term explained in Ayurveda where the expansion in dimension of Liver (Yakruta- vrudhi). So, in this study we have taken Virechanafollowed by Gomutraharitaki. Virechana Karma (purgation therapy) is indeedsuitableShodhanKarm(~purificatory procedure) for the liver disorders and recommanded best treatment for Pittaja and RaktajaRoga. Aim of the trial is to evaluate the efficacy of Virechan followed by Gomutra-haritaki in NAFLD and objective is to evaluate the efficacy of Virechana followed by Gomutra-haritaki on NFS in NAFLD.Diagnosed patients with NAFLD will be enrolled in 02 groups having sample Size of 78 (39 each group)
Cases of either sex between age 18 to 60 years, NAFLD confirmed by NFS score with or without having symptoms like fatigue, mild discomfort in the upper quadrant of abdomen etc, NAFLDpatients who are refractive to standard drugs of treatment, willing and able to participate in study and given written informed consent, yogya for Virechanawill be included.
Excessive utilization of alcohol in less than 2 years prior to first check up. Or alcohol intake more than 20g per day for female and less than 30 g per day for males, Uncontrolled systemic disease or medically unstable and major psychological disorders, use of drugs associated with NAFLD within 3 months, taking part in any other medicinal scientific research previously in 3 months, as well asengagement in any other NAFLD clinical trials, pregnant/lactating woman (involving positive pregnancy test at the first assessment/check up), Any dysfunction of liver besides NAFLD such as viral infection induced hepatitis, ascites, portal hypertension, Hepatic cell carcinoma, Auto- immune hepatitis, Primary biliary cirrhosis, Wilsons disease, and liver transplantation or any other conditions interfering with the result of the treatment Alcoholic fatty liver disease patient &Virechanaayogyawill be under exclusion criteria.
In Group-I,VirechanaviaTrivritawalehawill be given followed by Gomuta-Hritakiwill be given orally as Samana with Anupana of ushnodaka with 2 tablets two times a day after taking mealfor 30 days. In Group-II, ursodeoxycholic acid (UDCA) will be given 300 mg/day. Total Duration of Treatment will be 60days
Total time period of the trial will be of 02 months in which regular check-ups of the registered cases will be done successive 30 days for successive 2 months.
Primary outcome will be improvement in NFS (Age, Hyperglycaemia, BMI, Albumin, PLT Count, AST / ALT ratio) along with changes in clinical presentations (relief of the following symptoms like Fatigue, indigestion, epigastric discomfort, pain abdomen, diarrhea, constipation,) at baseline, 60th day and 120th day