An interventional study of Livitol-70 in Alcoholic Liver Disease, sponsored by Composite Interceptive Med Science. Not yet recruiting at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-20.
Sponsored by Composite Interceptive Med Science · Not applicable, Interventional, and Supportive care
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.
73 studies on the registry are indexed under Liver Diseases, Alcoholic; 24 are open to participants now.
This study's planned enrollment of 40 is below the median of 85 across 43 interventional studies indexed under Liver Diseases, Alcoholic.
Browse Liver Diseases, Alcoholic studies →Composite Interceptive Med Science is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Livitol-70
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.
Change from baseline in AST(Aspartate Aminotransferase)
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Change in radiological response
The degree of fatty infiltration will be assessed by ultrasound.
Time frame: 3 months
Change in maddrey discriminant function(DF)
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2018; primary completion for Oct 2018, 5 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Composite Interceptive Med Science