NEED FOR THE STUDY                                                       

Fatty liver is defined as a condition, wherein large vacuoles of triglyceride fat accumulates in liver cells via the process of steatosis (Abnormal retention of lipids within a cell).⁽¹⁾ it  is new era disease it has no direct reference in ayurvedic classical text hence it concludes with yakruddalyodara, raktavahasrotasmoolvyadhi, yakrutvikara. It is one of the most common disorder because of increasing sedentary lifestyle, unhealthy dietary habits, alcohol consumption and drug toxicity.⁽²⁾ Defects in fattyacids metabolism are responsible for pathogenesis of Fatty liver, which may be due to imbalance in energy consumption and its combustion, resulting in lipid storage, or can be a consequence of peripheral resistance to insulin, whereby the transport of fatty acids from adipose tissue to the liver is increased. Impairment or inhibition of receptor molecules (PPAR-α, PPAR-γ and SREBP1) that control the enzymes responsible for the oxidation and synthesis of fatty acids appears to contribute to fat accumulation.⁽³⁾ Prevalence rate is up to 25.24% reported worldwide and 9-32% in India for Non- alcoholic fatty liver disease (NAFLD) and more than 90% of all heavy drinkers develop fatty liver. Among the alcoholic fatty liver disease (AFLD) population 34.3% may end up with cirrhosis. ⁽⁴⁾

The management principles of fatty liver in modern medicine is not specific yet but  to limit or to stop progression of condition or to reduce risk factors like lifestyle modification, weight reduction, anti-hyperlipidemic drugs and bariatric surgery. ⁽⁵⁾ The disease fatty liver may simulate with the concept of dushi visha effecting medhodhatvagni and medhodhatu vikara stanasamsharya in yakrut leading to yakrut vikara mentioned in the classical text of Ayurveda. The nidana for dushi visha and the medhodhatu vikara mentioned are due to excessive consumption of Meda Pradhan ahara(fatty food articles) ati snigdha, ati Madhura and Madyapana and vihara such as avyayama, avyavaya, divaswapa, aasyasukha, swapnasukha, associated with mandagni⁽⁶⁾ leads to lakshana such as ajeerna, aruchi, shotha and karma hani.  

The research question is in anukta vyadhi weather  Pathya, shodhana and rasayana are helpful specially  in treating FLD  and formulations having Ushna veerya, Amapachaka, Kapha-medohara, Lekhana, hepato-stimulant, hepato-protective have effect. Anantadi churna⁽⁷⁾ for deepan pachan have sadyo jwarahar, deepana, and anulomana property. One year purana Indukanta ghrita⁽⁸⁾ used for for snehapana is  vatamayaghna, kshayahara, mahodarahara, gulmahara, shulahara, nimnonnata jwaraghna,and  balavardhana. Pathyadi yoga⁽⁹⁾  for virechan is mentioned as sarvashreshta virechana. Yakrat shula vinashini vati⁽¹⁰⁾ is indicated in yakrit vikara, gulma, pleeha udara. Phaltrikadi kashaya⁽¹¹⁾ is indicated for pandu kamla. Sharpunkha kshara⁽¹²⁾ and Sharpunkha kashaya⁽¹³⁾  are having properties like yakrut, pleeha, gulma, vrana,and vishahara Among shodahana procedure Virechana karma is the first line of management for Pittajanya Raktajanya and Pittashayagata vikara.All of the above medicines can prove beneficial in the management of fatty liver disease (yakrutgatamedoroga).

So , with an alternate hypothesis, deepan pachan , snehapanapoorvaka virechan and shaman rasayan has role on  fatty liver disease over only alone shaman rasayana without shodhan , the present study entitled AN OPEN LABELLED RCT STUDY TO ASSESS THE COMBINED EFFECT OF VIRECHANOTTARA YAKRUTSHOOLVINASHANI VATI WITH PHALATRIKADI KASHAYA OVER SHARPUNKHA KSHARA WITH SHARAPUNKHA KASHAYA IN FATTY LIVER DISEASE (YAKRUTGATAMEDOROGA) is undertaken.

OBJECTIVES OF THE STUDY

1)     To evaluate the combined effect tof Deepana Pachana with Anantadi churna, Snehapana with Purana Indukant ghrita, Virechan with Pathyadi yoga followed by Yakrutshoolvinashini Vati with Phalatrikadi Kashaya anupanain management of Fatty Liver Disease.

2)     To evaluate the alone effect of  Sharpunkha Kshara and Sharpunkha Kashaya in management of Fatty Liver Disease

3)     To compare the combined effect of Deepana Pachana with Anantadi churna, Snehapana with Purana Indukanta ghrita, Virechana with Pathyadi yoga followed by Yakrutshoolvinashini Vati with  Phalatrikadi Kashaya anupana over Sharpunkha Kshara and Sharpunkha Kashaya in management of Fatty Liver Disease.

 DESIGN OF THE STUDY:

 Study design              -           Prospective,  standard controlled comparative .

 Sample size                -           Minimum of 40 subjects.

Allocation                  -           Randomised

Intervention model    -           Double group assignment

Masking                     -           Open

Primary purpose        -           Treatment

Duration of study       -           45 days

Follow-up                  -           15 days after trail.

Assessment criteria:

SUBJECTIVE PARAMETERS

v Aruchi (Anorexia)

v Agnimandya (Indigestion)

v Right upper quadrant discomfort

v Dourbalya (Fatigue)  

OBJECTIVE PARAMETERS

v USG abdomen

v LFT

v Lipid profile

v VA Scale for pain/discomfort

ASSESSMENT SCHEDULE

 0^th day – Pre-test assessment (Before intervention)

12^th day – Mid-test assessment (During treatment)

45^th day – Post-test assessment (After intervention)

60^th day – Follow-up test assessment (15 days after the trail intervention)

OVERALL ASSESSMENT

•        Good relief            -           Above 75% improvement.

•        Marked relief        -           51-74% improvement.

•        Moderate relief     -           26-50% improvement.

•        Mild relief             -           upto 25%.

•       No relief                -           0%