An Open Clinical Trial to evaluate the effectiveness of Mandurathi Kudineer in the management of Kaleeral Noi (Non-Alcoholic Fatty Liver Disease) among out patients attending Ayothidoss Pandithar Hospital, National Institute Of Siddha.

BACKGROUND:

NON-ALCOHOLIC FATTY LIVER  DISEASE(NAFLD) is the most prevalent chronic liver disease worldwide. Asia being a large, heterogeneous area with substantial variation in socioeconomic status and prevalence of obesity, diabetes mellitus, hypertension, and other metabolic diseases, it has an increasing prevalence of NAFLD with poor outcomincluding hepatocellular carcinoma and death. The prevalence in general population ranges from 11.2% to 37.2%  with a male to  female ratio of 2:1. Increasing sedentary lifestyles and changing dietary patterns plays a major role in the prevalence of this disease. Prevalence of adult NAFLD in the India has been reported between 6.7 and 55.1% of all cases with asymptomatic symptoms of Liver enzymes.

Non-alcoholic fatty liver disease is defined as fatty liver (FL) that is accumulation of lipids inside the hepatocytes exceeding 5% of  the weight of the liver, without Hepatitis B virus or Hepatitis C virus infection and in the absence of excessive ethanol intake (conventionally defined as an intake of ethanol>20g/day.

In Siddha literature liver disorders are grouped under “kaleeral Noi”also termed *as Maandha katti, Valapaateeral noi and Yagudham.*The causes (Noi varum vazhi) of KALEERAL NOIis mentioned as excessive intake of food, taking unhealthy and heavy diets, long termintake of alcoholic beverages.Thus,  the premonitary symptoms  (Murkurikunangal) of KALEERAL NOI, mentioned in the text such as pasiyinmai(anorexia),  seriyamai(indigestion),  suvaiyinmai(tastelessness), kaalaiyil pithamaga vaanthiyadhal(fullness and belching), vaai neer ooral(increased salivary seretion), vayiru naaluku naal peruthal(increased echogenicity of liver due to fatty acid flux),valapaateeral peruthal (hepatomegaly) can be correlated to Non-Alcoholic Fatty Liver Disease. The therapeutic effectiveness of this classical Siddha herbal formulation “MANDURATHI KUDINEER” has not yet been evaluated scientifically,  So, this study makes an  attempt to evaluate its  effectiveness  in an open clinical trial.

OBJECTIVE:

PRIMARY OBJECTIVE:

To evaluate the therapeutic effectiveness of siddha herbomineral formulation â€œMANDURATHI  KUDINEER” in the management of KALEERAL NOI(NON-ALCOHOLIC FATTY LIVER DISEASE) by assessment of reduction in the  grades of  fatty liver through USG among the out participants attending  Ayothidoss Pandithar Hospital, National Institute of Siddha.

SECONDARY OBJECTIVE

1         To evaluate the changes in Liver Function Test, lipid profile and fasting blood glucose  of  the  participants

before and after treatment.

2. To evaluate the changes in Body Mass Index and Waist circumference of the participants before and after treatment.

METHODOLOGY:

A total of 20 diagnosed patients of kaleeral noi [ Non alcoholic fatty liver disease ] within the age limit of 20-65 years willing to paticipate in the study by signing the consent form will be enrolled in the study based on the inclusion criteria.

 PRIMARY OUTCOME:

Reduction in the Grades of fatty liver will be assessed by Ultra Sonogram before and after treatment.

 SECONDARY OUTCOME:

1**.**Changes in Liver function test,Lipid profile and Fasting blood sugar will be assessed before and after treatment.

2.Changes in waist circumference and Body mass index will be assessed before and after treatment.

 **RESULTS AND DISCUSSION:**The results will be statistically analysed.

KEYWORDS: Kaleeral noi, Non alcoholic fatty liver disease, Mandurathi kudineer, Kudineer.