Management of NAFLD through Ayurveda

Not yet recruiting

Conditions: Metabolic disorder, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH,

Registration Number: CTRI/2022/02/040321

Lead Sponsor: CCRAS

Brief Summary: Non-alcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease in developed countries because of the obesity epidemic. Approximately 25% of the world’s population suffers with NAFLDNon-alcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease in developed countries because of the obesity epidemic. Approximately 25% of the world’s population suffers with NAFLDThe main goals of treatment are to improve steatosis and to prevent progression of the disease. Intense lifestyle modification and treatment of the risk factors are the cornerstones of disease management. Ayurveda is a holistic science that give prime importance to diet and regimen in maintenance of health and prevention of disease. The aetio-pathogenesis of NAFLD points to*MedodhatuDushti, DhatwagniMandya*with or withoutconcurrent*Rakta Dhatu Dushti*. Liver is considered as the seat of *DhatwagniPaka* and any disease afflicting liver or *Rakta* will produce *DhatwagniMandya*in the level of *Mamsa* and *Medas.* Considering this, two drugs with action on liver and *Medas*has been selected for this study.

*Arogyavardhini Vati*(AVR) is a *Kharaliya Rasaushadhi*(formulations containing metallominerals and mercurials) used for the treatment of different types of *Jvara* (fever), *Kushtha*(skin disorders), *Medoroga* (obesity), and other *Yakritvikara* (liver disorders)[[i]](file:///C:/Users/Dr%20Krishna%20Rao/Downloads/RevisedNAFLD%20proposal07.07.2021.docx#_edn1). It has been described in the 13th-century text by Rasa Vagbhata[[ii]](file:///C:/Users/Dr%20Krishna%20Rao/Downloads/RevisedNAFLD%20proposal07.07.2021.docx#_edn2). Previous study suggests the role of AVR in acute viral hepatitis and possesses significant effects on cytoprotection and recovery of the liver function[[iii]](file:///C:/Users/Dr%20Krishna%20Rao/Downloads/RevisedNAFLD%20proposal07.07.2021.docx#_edn3) and hepatoprotective effect against CCl4-induced liver injury[[iv]](file:///C:/Users/Dr%20Krishna%20Rao/Downloads/RevisedNAFLD%20proposal07.07.2021.docx#_edn4). Pippalyadyasava contains drugs which are predominantly *Katu* and *Tikta* in Rasa (taste), *Laghu* and *Ruksha* in *Guna*(property), *Katu*in *Vipaka*and*Ushna* in *Virya* (potency). They mainly act as *Deepana* and *Pachana* and thus correct the *Agni Mandya*

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Diagnosed cases of Grade- I&II of Non-alcoholic fatty liver disease as evident fatty infiltration on Ultrasound.
Either sex aged between18- 60 years.
Subjects of non-alcoholic fatty liver disease with their hepatic enzymes <2 times upper normal limit (Normal limits AST 5-40U/L and ALT 7-56U/L).
Willing to provide written consent and able to participate for 4 months in the study.

Exclusion Criteria

H/o habitual consumption of alcohol intake of >20g/day for women,>40g/day for men Any other identified cause of chronic liver disease The use of medication which would cause non-alcoholic fatty liver.
disease e.g. tamoxifen Already taking supplementary medicine for NAFLD On anticoagulants (antiplatelet aggregators are permitted) Past history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. Symptomatic patients with clinical evidence of congestive cardiac failure. Subjects with concurrent Renal Dysfunction (defined as S. creatinine> 1.2 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. Uncontrolled Diabetes Mellitus (HbA1C>8) Known cases of HIV and AIDS, malignancy, Hepatitis B Subjects participated in any other clinical trial. Women who are planning for conception / pregnant or lactating.Any other condition which the P.I. thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the change in fibroscan score (Kpa) and CAP value (Kpa) or MRI-PDFF	Baseline& 90th day

Secondary Outcome Measures

Name	Time	Method
To assess changes in ALT, AST, Serum bilirubin, Total proteins & Alkaline Phosphatase	Changes in Lipid profile

Trial Locations

Locations (1): CENTRAL AYURVEDA RESEARCH INSTITUTE
🇮🇳
West, DELHI, India
CENTRAL AYURVEDA RESEARCH INSTITUTE
🇮🇳West, DELHI, India
BANAMALI DAS
Principal investigator
08249683316
banamali.d@gmail.com
DrSeema Jain
Principal investigator
9911331074
dr_seema_jain@yahoo.co.in