Fatty liver is most benign extreme of spectrum characterized as accumulation of triglyceride within the cytoplasm of hepatocytes and refers to fat accumulation in the liver exceeding 5%- 10% by weight. Non-Alcoholic Fatty Liver Disease is an umbrella term for an arrangement of spectrum of liver pathology with different prognosis affecting people who drink little to no alcohol. 

When hepatic steatosis is present in the absence of alcohol consumption (less than 2 drink per day for male and 1 drink per day for female) along with exclusion of viral hepatitis, autoimmune liver disease, iron or copper overload, alpha 1 antitrypsin deficiency it is termed as Non-alcoholic fatty liver diseases or NAFLD. It includes a group of disorders ranging from simple steatosis to inflammatory steatohepatitis (NASH) and cirrhosis. It exists as a histologic spectrum, ranging from simple steatosis or steatosis with only mild inflammation (Type 1 and 2 NAFLD) to more severe steatohepatitis (type 3 and 4 NAFLD) or non-alcoholic steatohepatitis (NASH). Type 1 and 2 NAFLD infrequently progress to cirrhosis but type 3 and 4 NAFLD i.e. (NASH) progress to cirrhosis in as many as 15%to 20% of patients. Most clinical ominous extreme of NAFLD is usual complication of Cirrhosis and portal hypertension whereas hepatocellular carcinoma is now recognized as a late complication of NAFLD.  

Non-alcoholic fatty liver disease occurs in every age group of people, but especially in people in the age group 40s and 50s who are at high risk of heart disease being strongly associated with overweight, obesity and insulin resistance (DM II) however it can also occur in lean individuals, common in those with paucity of adipose depots (lipodystrophy). 50% risk of hepatic steatosis, NASH, liver fibrosis and liver cancer is due to hereditary. This condition is also closely linked to metabolic syndrome which is a cluster of abnormalities including increased abdominal fat, poor ability to use the hormone insulin, high blood pressure, and high triglyceride level in the blood. 

In Ayurveda, there is a broad description of term Yakritodara where measures of management of wide variety of diseases of liver are discussed including Fatty Liver. It describes mainly hepato-protective and hepatic-regenerative herbal agents which are trusted and tested and have simultaneously got the hepatoprotective effects and therefore thought to be extremely useful in the pathogenic conditions like Fatty liver.

Acharya Sushruta has considered Siravedha (procedure linked with bloodletting) as Ardha Chikitsa in Shalya Tantra, and is said to alleviate the diseases related to liver.

Over the past couple of decades, it has become clear that non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is the significant cause of liver disease. The prevalence of NAFLD is found to be more than 25% globally the prevalence of adult NAFLD in India has been reported between 6.7% and 55.1%. The presence of certain characteristics has been identified for the development of NAFLD. The prevalence of NAFLD is found to be higher among those with diabetes (55.5%–59.7%), overweight or obesity (64.6%–95%), and metabolic syndrome (73%).

Of all cases with an asymptomatic elevation of liver enzymes, NAFLD may be responsible for almost one-third. Furthermore, explant histology data from liver transplant centres suggest that two-third of the patients with ‘cryptogenic’ cirrhosis had NAFLD. The prevalence of paediatric NAFLD in India varies from 7.3% to 22.4% in the healthy population. The prevalence of NAFLD increases with age. 

The prevalence of prediabetes, diabetes, and metabolic syndrome among adults in India is 19–22%, 15–19%, and 30%, respectively, and is increasing in both urban and rural areas. Therefore, NAFLD prevalence is expected to increase more in coming days. The exponential evolution is reflected in the temporal change in NAFLD prevalence, which has increased by more than 50% from 25.26% (21.59-29.33) in 1990-2006 to 38.00% (33.71-42.49) in 2016-2019. So, it is important to know the burden of the disease and its health impact and have a proper management regarding this. Since no any FDA approved therapies are present for this specific condition, research and validation of the data present in Ayurveda classics is needed now. By keeping all the above facts in mind, the present clinical study has been planned in patients of NAFLD by using Ayurveda knowledge. 

Under the heading of Yakritodara a group of diseases ranging from simple hepatic steatosis to hepatomegaly to liver cirrhosis are correlated. According to Yoga Ratnakar, Vidahi and Abhisyandi Ahara lead to Rakta-Kapha Dusti which may lead to Yakritodara. NAFLD is defined as deposits of fats in hepatic cells which can be correlated to Yakritodara. So far as Samprapati is concerned, due to Agni Vikriti ama rasa is produced which again vitiates the Kapha Dosha and deposit of Meda dhatu in Yakrita leads to Yakritodara, which in contemporary science is termed as fatty liver disease. 

As per Acharya Caraka, the general line of treatment for Udar Roga is Virechana. As per Acharya Sushruta, Siravedhaon right arm is the line of treatment for Yakrit Roga. In Charaka Chikitsasthana Udara Chikitsa, Chitraka Ghrita, Hapushadya Churna are mentioned in all types of Udara Roga. Hence, Hapusadhya Churna is used for the purpose ofVirechana. Also, Rohitakadya Churna is said to eradicate Yakrit Roga as sun removes all darkness. Hence, all these medicines are beneficial for Yakritodara too. 

Since the treatments are different on different Samhitas, the efficacy of both needs validation during today’s era. Hence, the current study is planned to compare the efficacy of Virechana Karma followed by Rohitakadya Churna and Siravedhafollowed by Rohitakadya Churna orally in the management of Yakritodara with special reference to Non-Alcoholic Fatty Liver Disease (NAFLD).  

 DURATION OF CLINICAL TRIAL AND FOLLOW UP STUDY 

Total duration of trial- For Virechana approx. 21days+ 30days oral medication 

For Raktamokshan by Siravedha approx. 21 days (3 sittings in 7 days interval) + 30 days oral medication 

Follow up after treatment – after completion of treatment with Rohitakadya Churna (30days)

Aruchi and udara shula are taken for subjective parameters and NAFLD score is taken for objective parameters.