A Clinical trail to Evaluate the efficacy of Rohitaka Lauha in the management of Yakrit Vikara w.s.r.t. Non alcoholoc fatty liver disease (NAFLD)

RESEARCH QUESTION Can the Rohitak Lauh reverse the changes of NAFLD (Non-Alcoholic Fatty Liver Disorder) in NAFLD SCORE?

5. HYPOTHESIS Null Hypothesis (H0): There is no efficacy of Rohitak Lauh in NAFLD (Non-Alcoholic Fatty Liver Disorder).

Alternative Hypothesis (H1): There is significant effect of Rohitak Lauh in NAFLD (Non-Alcoholic Fatty Liver Disorder).

6. AIMS AND OBJECTIVES Aim: To evaluate the role of Rohitak Lauh in NAFLD with special reference to Yakrit Vikara (Non-Alcoholic Fatty Liver Disorder).

7. OBJECTIVES Primary Objective: To evaluate the role of Rohitak Lauh in NAFLD with special reference to Yakrit Vikara (Non-Alcoholic Fatty Liver Disorder) on the basis of NAFLD Score.

Secondary Objectives: As secondary objectives, the following will be assessed:

Body mass index (BMI) and waist circumference (WC)

Glucose metabolism biomarkers including blood glucose, glycated hemoglobin (HbA1c)

Blood ferritin levels

Biomarkers of liver damage, including transaminases, gamma-glutamyl transferase (GGT), and alkaline phosphatase (AP)

8. PLAN OF STUDY To fulfill the above-mentioned aims and objectives, the research work will be carried out as follows:

A. CONCEPTUAL STUDY The Ayurvedic and modern literature pertaining to Yakrit Vikara with special reference to NAFLD will be compiled and reviewed critically.

B. CLINICAL STUDY a. Source of Data: 110 subjects will be selected from OPD and IPD of Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh. Subjects will be randomly picked for the study using an open trial method in a single group after taking their consent.

b. Selection of Patients: Selection of the patients will be done after investigations.

c. Criteria for Selection:

Patients having classical signs and symptoms of Yakrit Vikara

Patients having NAFLD score between -1.455 to 0.675

Patients having Grade 1 to Grade 2 fatty liver changes on USG report

d. Inclusion Criteria:

Patients having Grade 1 to Grade 2 fatty liver changes on USG report

Age between 20 years and 70 years

Patients having NAFLD score between -1.455 to 0.675

Patients irrespective of sex, caste, and religion

e. Exclusion Criteria:

Age less than 20 years or more than 70 years

Patients having more than Grade 3A fatty liver on USG report

Patients having NAFLD score more than 0.675

Patients having any other metabolic disorders, malignancies, autoimmune disorders, or life-threatening disorders

Pregnant and lactating women

Patients with previously established diagnosis of chronic diseases including congestive heart failure, decompensated or severe lung disease, neoplasms, kidney disease, carriers of HIV, and advanced chronic liver diseases (Child-Pugh classification B and C) caused by any causal agent unrelated to NAFLD

Recreational drug users

Patients with an average intake of more than 20 g of alcohol per day and/or a history of alcoholic disease with abstention for less than 6 months

Patients on prescribed medication including steroids, estrogens, amiodarone, warfarin, anticonvulsants, antipsychotics, or chemotherapy drugs in the past 6 months

Patients having history of infections, surgery, trauma, or hospitalization in the past 30 days

Patients with chronic degenerative diseases of non-hepatic origin

f. Laboratory Investigations:

Complete Blood Count (CBC)

Serum Ferritin

Liver Function Test (LFT)

Gamma-Glutamyl Transferase (GGT)

Renal Function Test (RFT)

Lipid Profile

HbA1c

Random Blood Sugar

Ultrasound (Whole Abdomen)