An Open Label Single Arm Clinical Study To Evaluate The Combined Effect of Virechana And Trayantyadi Kashaya In Alcoholic Liver Disease

Phase 2

Not yet recruiting

Conditions: Alcoholic liver disease, unspecified. Ayurveda Condition: YAKRUDDALYUDARAH,

Registration Number: CTRI/2023/07/054967

Lead Sponsor: Dr Rakshith MM

Brief Summary: Alcoholic associated Liver Disease (ALD) comprise a spectrum of diseases associated with chronic Alcohol consumption ranging from Alcohol associated Fatty Liver Disease and Steatohepatitis (Alcoholic Hepatitis) to move advanced liver diseases including from fibrosis to cirrhosis.A high daily intake of Alcohol (>60g) in males and (>20 g) in females taken for more than 6 to 8 years, significantly increases the risk of ALD Alcoholic Fatty Liver is the earliest change and is almost universally present in heavy alcoholics. Among the Alcoholic Fatty Liver, 34.3% may end up with Cirrhosis. It is generally a benign condition with abstinence . Alcoholic Hepatitis occurs in 10% to 35% of heavy drinkers who develop necro inflammation with or without fat infiltration. Virechana is the first line of management for Pitta, Pittakapha, and Pittashayagata vikara.Trayantyadi Kashaya include Trayanti as one of the main ingredient which is directly indicated in Yakrit Vikaras as mentioned in Priyanighantu.

So present study an effort has been put forth to evaluate efficacy of Virechana and Trayantyadi Kashaya in Alcoholic liver disease.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.subjects having Alcohol dependence 1 year or more 2.Subjects full filling the diagnostic criteria 3.Subjects with or with out raised billirubin levl (0.1-10 mg/dl ) 4.Subjects not suffering from Alcoholic withdrawal symptoms 5.Subjects between the age group of 20-60 years irrespective of gender 6.Subjects with elevated LFT values.

Exclusion Criteria

1.Subjects diagnosed with HIV, HBV, Tuberculosis, Myocardial infarction, other systemic diseases which interfere with the course of treatment.
2.Subjects diagnosed with Cirrhosis of liver, Ascites, Viral hepatitis, Severe Alcoholic Hepatitis, and other Psychiatric diseases which interfere with the course of treatment.
3.Subjects diagnosed with other Psychoactive drug dependance.
4.Subjects under active administration of hepato-toxic drugs.
5.Pregnant Women and Lactating Mothers.
6.Subjects not fit for Virechana.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the LFT Values	Pre-test: 0th day. \| Post-test- After treatment: (Shamanaushadhi)

Secondary Outcome Measures

Name	Time	Method
Changes in the Ultrasound of Abdomen	Pre-test: 0th day.

Trial Locations

Locations (1): Jss Ayurveda Medical College
🇮🇳
Mysore, KARNATAKA, India
Jss Ayurveda Medical College
🇮🇳Mysore, KARNATAKA, India
Dr Rakshith M M
Principal investigator
8951051997
rakshithparashar97@gmail.com