Evaluating the effect of Punarnavashtak Ghana and life style changes in Metabolic Associated Fatty Liver Disease

Phase 2

Not yet recruiting

Conditions: Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH,

Brief Summary: This study is a randomizes double-blind placebo controlled clinical trial designed to evaluate the effect of Punarnavashtak Ghana a classical ayurvedic formulation along with lifestyle modification in the management of Metabolic Associated Fatty Liver Disease (MAFLD) with special reference to Yakrit Vikar as described in ayurveda.

The study aims to assess the imapact of Punarnavashtak Ghana on the basis of subjective and objective criteria and the diagnosis will be done on the basis of three phase screening-

**Phase 1 screening-**

At least one of the following criteria-

1.Obesity/overwight(BMI)>25 kg/m2 with symptoms

2.Presence of type 2 diebetes mallitus

3.Metabolic dysregulation defined by the presence of at least two of the seven metabolic risk criteria-

**Phase 2 screening-**

for Metabolic Dysregulation at least 2 of the 7 metabolic risk criteria

1.waist circumference >94 cm in male and >80 cm in women

2.BP >130/85 mmhg

3.plasma tryglyceride >150mg/dl

4.HDL cholestrol <40mg/dl for men and <50 mg /dl for women

5.Homa insulin resistance score>2.5

6. Plasma CRP >2mg/dl

7.Prediebetes

**Phase 3 screening-**

USG (abdomen)-Grade 1 to grade 2 Fatty liver changes

After the diagnosis the medicine should be administered to the patients and the outcome will be noted on the basis of subjective and objective criteria.

Recruitment & Eligibility

Inclusion Criteria

1.Patient of either sex between the age of 18 to 65 year.
2.Patients fulfilling diagnostic criteria as mentioned in brief summary.
3.Sonologically diagnosed and fresh cases with grade 1 and grade 2 fatty liver .
4.Patient who are willing for participation in the trial, ready to undergo study related procedures and fill the consent form.

Exclusion Criteria

1.Alcoholic steatohepatitis 2.K/C/O hepatitis B and C, cirrhosis of liver, Jaundice 3.Pregnant and lactating women.
4.The prescription of medication which would cause MAFLD ex.tamoxifen 5.Already taking supplementary medicine for NAFLD 6.Patient who has past history of cardiac Arrythmia, Acute coronary syndrome, myocardial infarction, symptomatic patient with clinical evidence of cardiac failure.

Primary Outcome Measures

Name	Time	Method
To study effect of Punarnavashtak Ghana with life style modification in comparision with placebo with life style modification on the basis of subjective parameter from baseline to end of study.	0 DAYS 30 DAYS 60 DAYS 90 DAYS

Secondary Outcome Measures

Name	Time	Method
To study the the effect of Punarnavashtak Ghana with life style modification in comparision with placebo on 1.Lipid profile	2.SGOT (AST), SGPT(ALT) levels

Locations (1): Khemdas hospital
🇮🇳
Vadodara, GUJARAT, India
Khemdas hospital
🇮🇳Vadodara, GUJARAT, India
Dr Devkanya khatediya
Principal investigator
7974318848
khatediyadevkanya@gmail.com