Alcoholic Liver DiseaseNCT03503708
Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease
A study testing Livitol-70 in people with Alcoholic Liver Disease, run by Composite Interceptive Med Science at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Liver Disease
- What is being tested?
- Livitol-70
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 30 May 2018to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Chronic alcohol intake, Identified with AUDIT(Alcohol Use Disorder Inventory Test) Questionnaire
- Active alcohol use until 4 weeks prior to presentation
- ALT and AST elevated >1.5 times the upper limit of normal
- Over 1.5 ratio of AST to ALT
- Maddrey Discriminant function(DF) less than 30
Who cannot join
- Severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months
- Severe renal impairment (Glomerular filtration rate below 60 ml/min per 1.73m2)
- Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilson's disease
- Participants with active viral hepatitis
- Under going active treatment for alcohol withdrawal syndrome(AWS) at the study entry
- Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.
- Pregnant, attempting to conceive, or lactating women
- Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Mazumdar Shaw Medical Centre
Bangalore, Karnataka, 560099
Alben Sigamani, MD, 8884431444, alben.sigamani.dr@narayanahealth.org
Sanjaya Chauhan, PharmD, 9611252350 ext. Chauhan, drsanjayachauhan49@gmail.com
About this study
Official title: Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study
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.
- Conditions
- Alcoholic Liver Disease
- Being tested
- Livitol-70
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Livitol-70Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Livitol-70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in AST(Aspartate Aminotransferase)
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (2)
Change in radiological response
The degree of fatty infiltration will be assessed by ultrasound.
Measured: 3 months
Change in maddrey discriminant function(DF)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start30 May 2018 (estimated)
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Composite Interceptive Med Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alben Sigamani, MD, Principal investigator, Narayana Hrudayalaya HospitalSanjaya Chauhan, PharmD, Study chair, Composite Interceptive Med Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503708
- Sponsor's protocol ID
- OI-009-2018
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study
- ClinicalTrials.gov ID
- NCT03503708
- Acronym / sponsor ID
- OI-009-2018
- Conditions
- Alcoholic Liver Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Composite Interceptive Med ScienceIndustry (pharma, biotech, devices)
- Study start
- 30 May 2018 (estimated)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Livitol-70All 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Chronic alcohol intake, Identified with AUDIT(Alcohol Use Disorder Inventory Test) Questionnaire
- Active alcohol use until 4 weeks prior to presentation
- ALT and AST elevated >1.5 times the upper limit of normal
- Over 1.5 ratio of AST to ALT
Key exclusion criteria (8 listed)
- Severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months
- Severe renal impairment (Glomerular filtration rate below 60 ml/min per 1.73m2)
- Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilson's disease
- Participants with active viral hepatitis
- Under going active treatment for alcohol withdrawal syndrome(AWS) at the study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Livitol-70Livitol-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. | Drug | Intervention Group |
Primary outcome
Change from baseline in AST(Aspartate Aminotransferase)
Time frame: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in ALT(Alanine Aminotransferase)
Time frame: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in ALP(Alkaline Phosphatase)
Time frame: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in GGT(Gamma Glutamyl Transferase)
Time frame: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in serum total bilirubin
Time frame: 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Number of Subject with adverse events
Time frame: 3 months
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.
2 secondary outcomes
Change in radiological response
Time frame: 3 months
Change in maddrey discriminant function(DF)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alben Sigamani, MD principal investigator
Narayana Hrudayalaya Hospital
Sanjaya Chauhan, PharmD study chair
Composite Interceptive Med Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Livitol-70 in people with Alcoholic Liver Disease, run by Composite Interceptive Med Science at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alben Sigamani, MD (8884431444, alben.sigamani.dr@narayanahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in AST(Aspartate Aminotransferase) (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.