Hepatic EncephalopathyPhase 4HERBNCT06538077
BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE
A Phase 4 study testing Oral Branched chain Amino acid, Rifaximin 550 MG and Lactulose in people with Hepatic Encephalopathy and Decompensated Cirrhosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Rationale Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy, Decompensated Cirrhosis, Minimal Hepatic Encephalopathy
- What is being tested?
- Oral Branched chain Amino acid, Rifaximin 550 MG and Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2025to Aug 2027
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis defined by standard clinical, ultrasonographic findings and/or histological criteria. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid doses for ≥3-month period before study inclusion; those with viral hepatitis, must similarly be on anti-viral therapy with controlled viremia or with SVR.
- Any gender
- Discharged from the hospital following an episode of overt hepatic encephalopathy.
- Participants able to give informed consent
Who cannot join
- Subjects with active bacterial or fungal infection
- Subjects with active or very recent gastrointestinal bleeding in the last 2 weeks.
- Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification.
- Conditions that can impact interpretation of cognitive function:
- Untreated viremic hepatitis C virus infection ii) Established neurological/degenerative disorders iii) Patient undergoing active alcohol withdrawal treatment Iv) Patient is intoxicated or under the influence of illicit drugs as per clinician assessment V) Treatment with antipsychotics or other psychotropic drugs with sedative effects
- Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months.
Show all 13Show fewer
- Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including: i) Congestive heart failure New York Heart Association Grade III/IV or ejection fraction<30% ii) COPD: GOLD >2, ii) Chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
- Patients with current extra hepatic malignancies, including solid tumours and hematologic disorders.
- Patients with MELD>20
- Patients with mental incapacity, or those unlikely to survive 12 weeks or any other reason considered by the investigator precluding adequate understanding, cooperation, or compliance in the study activities.
- Patients with TIPS shunt in situ
- Pregnancy (urine pregnancy test at inclusion)
- Refusal or inability to give informed consent
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, 1 recruiting
- Recruiting
PGIMER
Chandigarh
Anchal Sandhu, +9101722754777, anchalsandhu04@gmail.com
About this study
Official title: Branch Chain Amino Acids vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of Hepatic Encephalopathy: Double-blind Placebo-controlled Multicentric Randomized Controlled Trial
Rationale
- Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health.
- A multicentric pan-India team will evaluate the role of oral branched-chain amino acids (BCAA) vs Rifaximin as secondary prophylaxis following overt HE as compared with improvement in cognitive function.
Read more
Novelty:
- This study is intended to investigate the role of BCAA vs rifaximin as the ideal second-line therapy for HE management, recurrence, and overall health, including cognitive function, depression and anxiety.
- The head-to-head comparison of BCAA+lactulose+ pill-placebo vs rifaximin+ lactulose+ powder-placebo ensures minimization of bias and has adequate power to determine rates of recurrence,
Objectives:
- To assess the 1st breakthrough episode of HE during 6months in BCAA vs rifaximin groups as ideal secondary prophylaxis in HE. Methodology
- Double-blind placebo-controlled double-dummy randomized trial of BCAA supplementation vs rifaximin as the ideal second-line therapy in patients with cirrhosis who have recovered from an episode of OHE. Expected Outcome
- Ideal second line agent HE prophylaxis (rifaximin or BCAA) following 1st line lactulose is unclear in an Indian context where dysbiosis and sarcopenia are prevalent, and cost of therapy needs to be optimized.
- Optimal HE management prevents recurrence episodes of HE, and improves prognosis, neurocognitive function, and overall health-related quality of life(HRQOL).
- Creation of a management algorithm based deductive models incorporating etiology and severity of liver disease, cognitive performance, sarcopenia, and ammonia, and neuropsychiatric impact of using BCAA vs Rifaximin will be created.
Read the detailed description
Hepatic encephalopathy (HE), a complex neuropsychiatric syndrome arising from liver dysfunction and the establishment of portosystemic shunts (PSS), presents a significant clinical challenge, marked by a spectrum of cognitive, emotional, and motor disturbances. These conditions necessitate precise diagnostic and therapeutic approaches to mitigate its impact on patient well-being and quality of life.
- The prevalence of OHE at the time of diagnosis of cirrhosis is 10%-14% in general, 16%-21% in those with decompensated cirrhosis. The cumulated numbers indicate that OHE will occur in 30%-40% of those with cirrhosis at some time during their clinical course and in the survivors in most cases repeatedly. Minimal HE (MHE) or covert HE (CHE) occurs in 20%-80% of patients with cirrhosis. This high incidence rate calls for effective, accessible, and cost-efficient treatment modalities to improve patient outcomes and quality of life.
- Indian patients have sarcopenia and reduced muscle strength impairing peripheral ammonia metabolism, and also have gut dysbiosis which can predispose to another episode of HE. A critical initial step in addressing HE involves the identification of precipitating factors, with evidence suggesting that reversible elements contribute to over 80% of HE cases.
- Current therapeutic interventions primarily target the reduction of blood ammonia levels, yet the effectiveness of these treatments varies, underscoring the necessity for ongoing research and innovation in HE management.
- Patients recovering from OHE are at risk of recurrent episodes and may suffer from persistent MHE, a condition often undiagnosed due to its subtle cognitive manifestations. Such individuals may have cognitive impairment that affect patients' daily functioning and mental health, necessitating the development of standardized diagnostic psychometric tests protocols tailored to diverse populations.
- Mainstay for treatment of HE has been lactulose or lactitol. How lactulose acts in HE has been a matter of debate and various hypotheses have been postulated. Inglefenger et al., suggested it to be due to proliferation of Lactobacillus with inhibition of Bacteroides and other organisms (28). Lactulose has pleiotropic effects, and reduction of ammonia is only one of the ways in which it acts on HE.
- Rifaximin is an oral antibiotic having <0.4% of systemic absorption. It acts against coliforms like Escherichia coli and plays a role in the reduction of ammonia levels and prevention of recurrence of HE . Several trials have compared Rifaximin as a therapy of HE with placebo, neomycin and non-absorbable disaccharides . Rifaximin emerged as a promising alternative, showing comparable efficacy in managing OHE and preventing its recurrence..
- This is a double-blind, randomized placebo-controlled trial of branched-chain amino acid supplementation vs rifaximin as the ideal second-line therapy in patients with cirrhosis who have recovered from an episode of overt hepatic encephalopathy, with either drug given over 12 weeks with endpoints being prevention of recurrence of another episode of HE, efficacy, safety, and improvement in neurocognitive function
- Being tested
- Oral Branched chain Amino acid, Rifaximin 550 MG, Lactulose, Placebo for BCAA, Placebo for Rifaximin 550mg
- Keywords
- Hepatic encephalopathy, Branched-chain amino acids, Computerized neurocognitive test battery, Double blind placebo controlled multicentric randomized controlled trial, rifaximin
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Branched chain Amino acidDrug
The active drug BCAA supplement will be dispensed in a dose of 15 gm once daily x 12 weeks
Rifaximin 550 MGDrug
Active drug rifaximin will be dispensed in a dose of 550mg twice daily x 12 weeks
LactuloseDrug
Both groups will be treated with will be treated with 30-60 ml lactulose three times a day to ensure passage of 2-3 semisoft stools per day
Placebo for BCAADrug
A placebo comparator of 15 gm of skimmed milk powder will be used.
Placebo for Rifaximin 550mgDrug
Identical placebo sugar pills will be used as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| A1=Experimental: | Experimental | Drug: Oral BCAA + Rifaximin placebo + Lactulose ( Oral BCAA 15 gm in once daily dose With Lactulose for 12 weeks) Receives: Drug: Oral Branched chain Amino acid; Drug: Lactulose; Drug: Placebo for Rifaximin 550mg |
| A2= Experimental: | Experimental | Drug: Rifaximin+ BCAA Placebo + Lactulose ( Oral Rifaximin 550 mg twice daily daily + Lactulose therapy for 12 weeks) Receives: Drug: Rifaximin 550 MG; Drug: Lactulose; Drug: Placebo for BCAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of breakthrough event of overt hepatic encephalopathy in BCAA vs rifaximin arm
Time to a breakthrough overt HE episode will be the duration (number of days) from time of first dose of study drug to the first breakthrough overt HE episode. The number of events of a first breakthrough overt HE episode during the treatment period will be assessed
Measured: 24 Weeks
Secondary outcomes (17)
Computerized Cognitive Test battery for Cognitive performance
A curated Computer based Cognitive test battery has been created for this protocol with a fixed set of tasks comprising Animal Naming Test, reaction times, digit span and number connection tests. This has been designed using the PEBL opensource language. Psychology Experiment Building Language. [2019-03] PEBL Version 2.1. The battery has been validated by us previously in patients with chronic hepatitis C infection.
Measured: At Enrolment
Computerized Cognitive Test battery for Cognitive performance
Computerized Cognitive Test battery: A curated Computer based Cognitive test battery has been created for this protocol with a fixed set of tasks comprising Animal Naming Test, reaction times, digit span and number connection tests. This has been designed using the PEBL opensource language. Psychology Experiment Building Language. [2019-03] PEBL Version 2.1. The battery has been validated by us previously in patients with chronic hepatitis C infection.
Measured: 30 days
Computerized Cognitive Test battery for Cognitive performance
Computerized Cognitive Test battery A curated Computer based Cognitive test battery has been created for this protocol with a fixed set of tasks comprising Animal Naming Test, reaction times, digit span and number connection tests. This has been designed using the PEBL opensource language. Psychology Experiment Building Language. [2019-03] PEBL Version 2.1. The battery has been validated by us previously in patients with chronic hepatitis C infection.
Measured: 90 days
Psychiatric Assessment
Beck's Depression Inventory (BDI) test will be performed. The scoring is as follows 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression31-40: Severe depression 40: Extreme depression
Measured: 0 days
Psychiatric Assessment
Generalized anxiety disorder (GAD 7 score) will be performed. It has 7 questions. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD
Measured: 0 days
Psychiatric Assessment
Generalized anxiety disorder (GAD 7 score) test will be performed
Measured: 30 days
Psychiatric Assessment
Beck's Depression Inventory (BDI) test will be performed. The scoring is as follows 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression31-40: Severe depression 40: Extreme depression
Measured: 30 days
Psychiatric Assessment
Beck's Depression Inventory (BDI)test will be performed The scoring is as follows 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression31-40: Severe depression 40: Extreme depression
Measured: 90 days
Psychiatric Assessment
Generalized anxiety disorder (GAD 7 score) tests will be performed
Measured: 90 days
HRQOL will be performed by SF-36
Health related query of life will be performed.
Measured: 0 days
HRQOL will be performed by SF-36
Health related query of life will be performed.
Measured: 30 days
HRQOL will be performed by SF-36
Health related query of life will be performed.
Measured: 90 days
Assessment of changes in ammonia
Estimation of ammonia by arterial fasting test/ capillary test will be performed
Measured: At enrolment
Assessment of changes in ammonia
Estimation of ammonia by arterial fasting test/ capillary test will be performed
Measured: 24 week
Assessment of changes in muscle health
Estimation of sarcopenia will be performed by muscle ultrasound by SARCUS.
Measured: Baseline
Assessment of changes in muscle health
Estimation of sarcopenia by muscle ultrasound by SARCUS.
Measured: 30 days
Assessment of changes in muscle health
Estimation of sarcopenia by muscle ultrasound by SARCUS.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Feb 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In addition to the BCAA vs Rifaximin, both groups will be treated with 30-60 ml lactulose three times a day to ensure passage of 2-3 semisoft stools per day.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538077
- Sponsor's protocol ID
- PGI/HEP/567
- Acronym
- HERB
- Status last verified
- Jun 2025
- First submitted
- 23 Apr 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Branch Chain Amino Acids vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of Hepatic Encephalopathy: Double-blind Placebo-controlled Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06538077
- Acronym / sponsor ID
- HERB / PGI/HEP/567
- Keywords
- Hepatic encephalopathy, Branched-chain amino acids, Computerized neurocognitive test battery, Double blind placebo controlled multicentric randomized controlled trial, rifaximin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Aug 2024 (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.
Rationale
- Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health.
- A multicentric pan-India team will evaluate the role of oral branched-chain amino acids (BCAA) vs Rifaximin as secondary prophylaxis following overt HE as compared with improvement in cognitive function.
Novelty:
- This study is intended to investigate the role of BCAA vs rifaximin as the ideal second-line therapy for HE management, recurrence, and overall health, including cognitive function, depression and anxiety.
- The head-to-head comparison of BCAA+lactulose+ pill-placebo vs rifaximin+ lactulose+ powder-placebo ensures minimization of bias and has adequate power to determine rates of recurrence,
Objectives:
- To assess the 1st breakthrough episode of HE during 6months in BCAA vs rifaximin groups as ideal secondary prophylaxis in HE. Methodology
- Double-blind placebo-controlled double-dummy randomized trial of BCAA supplementation vs rifaximin as the ideal second-line therapy in patients with cirrhosis who have recovered from an episode of OHE. Expected Outcome
- Ideal second line agent HE prophylaxis (rifaximin or BCAA) following 1st line lactulose is unclear in an Indian context where dysbiosis and sarcopenia are prevalent, and cost of therapy needs to be optimized.
- Optimal HE management prevents recurrence episodes of HE, and improves prognosis, neurocognitive function, and overall health-related quality of life(HRQOL).
- Creation of a management algorithm based deductive models incorporating etiology and severity of liver disease, cognitive performance, sarcopenia, and ammonia, and neuropsychiatric impact of using BCAA vs Rifaximin will be created.
Detailed description
Hepatic encephalopathy (HE), a complex neuropsychiatric syndrome arising from liver dysfunction and the establishment of portosystemic shunts (PSS), presents a significant clinical challenge, marked by a spectrum of cognitive, emotional, and motor disturbances. These conditions necessitate precise diagnostic and therapeutic approaches to mitigate its impact on patient well-being and quality of life.
- The prevalence of OHE at the time of diagnosis of cirrhosis is 10%-14% in general, 16%-21% in those with decompensated cirrhosis. The cumulated numbers indicate that OHE will occur in 30%-40% of those with cirrhosis at some time during their clinical course and in the survivors in most cases repeatedly. Minimal HE (MHE) or covert HE (CHE) occurs in 20%-80% of patients with cirrhosis. This high incidence rate calls for effective, accessible, and cost-efficient treatment modalities to improve patient outcomes and quality of life.
- Indian patients have sarcopenia and reduced muscle strength impairing peripheral ammonia metabolism, and also have gut dysbiosis which can predispose to another episode of HE. A critical initial step in addressing HE involves the identification of precipitating factors, with evidence suggesting that reversible elements contribute to over 80% of HE cases.
- Current therapeutic interventions primarily target the reduction of blood ammonia levels, yet the effectiveness of these treatments varies, underscoring the necessity for ongoing research and innovation in HE management.
- Patients recovering from OHE are at risk of recurrent episodes and may suffer from persistent MHE, a condition often undiagnosed due to its subtle cognitive manifestations. Such individuals may have cognitive impairment that affect patients' daily functioning and mental health, necessitating the development of standardized diagnostic psychometric tests protocols tailored to diverse populations.
- Mainstay for treatment of HE has been lactulose or lactitol. How lactulose acts in HE has been a matter of debate and various hypotheses have been postulated. Inglefenger et al., suggested it to be due to proliferation of Lactobacillus with inhibition of Bacteroides and other organisms (28). Lactulose has pleiotropic effects, and reduction of ammonia is only one of the ways in which it acts on HE.
- Rifaximin is an oral antibiotic having <0.4% of systemic absorption. It acts against coliforms like Escherichia coli and plays a role in the reduction of ammonia levels and prevention of recurrence of HE . Several trials have compared Rifaximin as a therapy of HE with placebo, neomycin and non-absorbable disaccharides . Rifaximin emerged as a promising alternative, showing comparable efficacy in managing OHE and preventing its recurrence..
- This is a double-blind, randomized placebo-controlled trial of branched-chain amino acid supplementation vs rifaximin as the ideal second-line therapy in patients with cirrhosis who have recovered from an episode of overt hepatic encephalopathy, with either drug given over 12 weeks with endpoints being prevention of recurrence of another episode of HE, efficacy, safety, and improvement in neurocognitive function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In addition to the BCAA vs Rifaximin, both groups will be treated with 30-60 ml lactulose three times a day to ensure passage of 2-3 semisoft stools per day.
| Arm | Type | Receives |
|---|---|---|
| A1=Experimental: | Experimental | Drug: Oral Branched chain Amino acid, Drug: Lactulose, Drug: Placebo for Rifaximin 550mgDrug: Oral BCAA + Rifaximin placebo + Lactulose ( Oral BCAA 15 gm in once daily dose With Lactulose for 12 weeks) |
| A2= Experimental: | Experimental | Drug: Rifaximin 550 MG, Drug: Lactulose, Drug: Placebo for BCAADrug: Rifaximin+ BCAA Placebo + Lactulose ( Oral Rifaximin 550 mg twice daily daily + Lactulose therapy for 12 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhosis defined by standard clinical, ultrasonographic findings and/or histological criteria. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid doses for ≥3-month period before study inclusion; those with viral hepatitis, must similarly be on anti-viral therapy with controlled viremia or with SVR.
- Any gender
- Discharged from the hospital following an episode of overt hepatic encephalopathy.
- Participants able to give informed consent
Key exclusion criteria (13 listed)
- Subjects with active bacterial or fungal infection
- Subjects with active or very recent gastrointestinal bleeding in the last 2 weeks.
- Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification.
- Conditions that can impact interpretation of cognitive function:
- Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months.
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 |
|---|---|---|
| Oral Branched chain Amino acidThe active drug BCAA supplement will be dispensed in a dose of 15 gm once daily x 12 weeks | Drug | A1=Experimental: |
| Rifaximin 550 MGActive drug rifaximin will be dispensed in a dose of 550mg twice daily x 12 weeks | Drug | A2= Experimental: |
| LactuloseBoth groups will be treated with will be treated with 30-60 ml lactulose three times a day to ensure passage of 2-3 semisoft stools per day | Drug | A1=Experimental:, A2= Experimental: |
| Placebo for BCAAA placebo comparator of 15 gm of skimmed milk powder will be used. | Drug | A2= Experimental: |
| Placebo for Rifaximin 550mgIdentical placebo sugar pills will be used as a placebo. | Drug | A1=Experimental: |
Primary outcome
Number of breakthrough event of overt hepatic encephalopathy in BCAA vs rifaximin arm
Time frame: 24 Weeks
Time to a breakthrough overt HE episode will be the duration (number of days) from time of first dose of study drug to the first breakthrough overt HE episode. The number of events of a first breakthrough overt HE episode during the treatment period will be assessed
17 secondary outcomes
Computerized Cognitive Test battery for Cognitive performance
Time frame: At Enrolment
Computerized Cognitive Test battery for Cognitive performance
Time frame: 30 days
Computerized Cognitive Test battery for Cognitive performance
Time frame: 90 days
Psychiatric Assessment
Time frame: 0 days
Psychiatric Assessment
Time frame: 0 days
Psychiatric Assessment
Time frame: 30 days
Psychiatric Assessment
Time frame: 30 days
Psychiatric Assessment
Time frame: 90 days
Psychiatric Assessment
Time frame: 90 days
HRQOL will be performed by SF-36
Time frame: 0 days
HRQOL will be performed by SF-36
Time frame: 30 days
HRQOL will be performed by SF-36
Time frame: 90 days
Assessment of changes in ammonia
Time frame: At enrolment
Assessment of changes in ammonia
Time frame: 24 week
Assessment of changes in muscle health
Time frame: Baseline
Assessment of changes in muscle health
Time frame: 30 days
Assessment of changes in muscle health
Time frame: 90 days
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 10 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Branched chain Amino acid, Rifaximin 550 MG and Lactulose in people with Hepatic Encephalopathy and Decompensated Cirrhosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 10 Jun 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Madhumita Premkumar (+9101722754777, drmadhumitap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of breakthrough event of overt hepatic encephalopathy in BCAA vs rifaximin arm (time frame: 24 Weeks). 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 10 Jun 2025.