An Open Labelled RCT Study To Assess The Cobined Effect Of Virechanottara Yakrutshoolvinashini Vati With Phalatrikadi Kashaya Over Sharapunkha Kshara With Sharapunkha Kashaya In Fatty Liver Disease (Yakrutgatamedoroga)

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 forfor 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 STUDY1)     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 PARAMETERSv Aruchi (Anorexia)

v Agnimandya (Indigestion)

v Right upper quadrant discomfort

v Dourbalya (Fatigue)

ARUCHI

GRADING

|Normal Desire to eat

CS0

|Decreased desire to eat with no nausea

CD1

|Decreased desire to eat with nausea

CD2

|No desire to eat with severe nausea

CD3

 

AGNIMANDYA

GRADING

|Three meals a day with no indigestion

CS0

|Three meals a day with indigestion

CD1

|Two meals a day with indigestion

CD2

|One meal a day with indigestion

CD3

  

DOURBALYA

GRADING

|No Fatigue

CS0

|Mild Fatigue, Occasional Fatigue on light activities

CD1

|Moderate Fatigue, Constant feeling of Fatigue on heavy activities

CD2

|More Fatigue, Feeling Fatigue all the time

CD3

  

**Right upper
quadrant abdominal discomfort/pain**

Scale by NCBI

GRADING

|Low disability, low intensity

CS0

|Low disability, high intensity

CD1

|High disability, moderately limiting

CD2

|High disability, severely limiting

CD3

  OBJECTIVE PARAMETERSv USG abdomenv LFT

v Lipid profile

v VA Scale for pain/discomfort

 ASSESSMENT SCHEDULE

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

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

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

60th 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%