Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Alcoholic liver disease represents the major health issues and it ranges from simple steatosis to cirrhosis. There is a paucity of data to support the allopathic intervention among these group of patients. Livitol-17 consist of the 3 whole herbs and extract which has antioxidant, hepatoprotective as well as reno-protective properties. The aim of this trial is to study the efficacy of herbal supplement to improve the liver function of alcoholic liver disease subject.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | All the eligible participants will receive Livitol-17 capsules. It consist of 390 mg of whole herbs and extract of Phyllanthus niruri (Bhumyamalaki), Boerhaavia diffusa (Punarnava) and Picroorrhiza kurroa (Katuki). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livitol-70 | Drug | Livitol-17 detoxifies, purifies and rejuvenates liver, kidney and spleen. Participants will be given the intervention in two bottles at each visit. Participant will be instructed to take two capsule twice daily at a fixed time in the day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in AST(Aspartate Aminotransferase) | The above mentioned test will be measured with panel of Liver function test at central laboratory. | 3 months |
| Change from baseline in ALT(Alanine Aminotransferase) | The above mentioned test will be measured with panel of Liver function test at central laboratory. | 3 months |
| Change from baseline in ALP(Alkaline Phosphatase) | The above mentioned test will be measured with panel of Liver function test at central laboratory. | 3 months |
| Change from baseline in GGT(Gamma Glutamyl Transferase) | The above mentioned test will be measured with panel of Liver function test at central laboratory. | 3 months |
| Change from baseline in serum total bilirubin | The above mentioned test will be measured with panel of Liver function test at central laboratory. | 3 months |
| Number of Subject with adverse events | Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in radiological response | The degree of fatty infiltration will be assessed by ultrasound. | 3 months |
| Change in maddrey discriminant function(DF) | 3 months |
Not provided
Inclusion Criteria:
Adults aged over 18 years with the evidence of alcoholic liver disease (ALD) based on a thorough history, physical examination, and laboratory tests and all of the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alben Sigamani, MD | Contact | 8884431444 | alben.sigamani.dr@narayanahealth.org | |
| Sanjaya Chauhan, PharmD | Contact | 9611252350 | drsanjayachauhan49@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alben Sigamani, MD | Narayana Hrudayalaya Hospital | Principal Investigator |
| Sanjaya Chauhan, PharmD | Composite Interceptive Med Science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mazumdar Shaw Medical Centre | Bangalore | Karnataka | 560099 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |