Health Condition 1: K70- Alcoholic liver disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: History of Alcoholic Abuse for more than five years and the Alcoholic dependency will be confirmed by AUDIT questionnaire Subjects who are willing to quit Alcohol Participants with clinical signs and symptoms of early stages of Alcoholic Liver Disease that confirmed with USG. Individuals with elevated Liver enzymes Total bilirubin Direct and Indirect Bilirubin levels such as AST,ALT,ALP, GGT and lipid profile Patients with an MDF score of less than 32
Exclusion criteria
Exclusion criteria: Individuals with advanced stages of Alcoholic liver disease with MELD score of greater than 20 Withdrawal symptoms like seizure , Alcohol Withdrawal Delirium and Alcohol Hallucinosis Substance abuse other than alcohol like Narcotics Pregnant and Lactating women participants with known liver diseases such as inherited metabolic causes Hemochromatosis Wilsons disease Hepatic infection and hepatic carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Therapeutic effectiveness of Siddha formulations will be evaluated by observing improvement in clinical signs and symptoms after treatment.Timepoint: Screening Period: 2 Months Trial period: 14 months Assessment Period:2 Months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring the changes in the MDF score & MELD SCORE, Lab parameters including LFT (Serum Bilirubin, AST, ALT, ALP, GGT), & lipid profile with its permissible limit after treatment. Observing the changes in hematological, liver, & renal functional markers will ensure the safety of the trial drugs.Timepoint: Screening period: 2 months Trial period: 14 months Assessment period:2 months | — |
Countries
India
Contacts
National Institute of Siddha