Non Alcholic Fatty Liver DiseaseNCT07452744
Efficacy and Safety of Picroliv in Patients With Non-Alcoholic Fatty Liver Disease
A study testing Picroliv in people with Non Alcholic Fatty Liver Disease, run by Bioagile Therapeutics Pvt. Ltd. at 6 sites in India.
Trial summary
This is a Phase III, multicentre, randomized, double-blind, placebo-controlled, interventional study designed to evaluate the efficacy and safety of a standardized fraction of Picrorhiza kurroa Royal Ex Benth (Picroliv®) in adults with Non-Alcoholic Fatty Liver Disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non Alcholic Fatty Liver Disease
- What is being tested?
- Picroliv
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 6 sitesIndia
- Study dates
- 13 Aug 2024to 15 Aug 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18- 60 years
- Sex: Both males and females
- Patients showing presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at screening.
- Liver enzymes normal or above the ULN (upper limit of normal range) but less than 3 times
- Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 109/L, and a white blood cell count ≥ 3.0 x 109/L
- HbA1c < 7% (if participant has Type 2 diabetes mellitus (T2DM) should be controlled with appropriate treatment for the same except thiazolidinediones)
- TSH within normal limits (WNL) at screening
- If on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to Screening and during the study will be allowed if on stable doses in the preceding 12 weeks and will be continued throughout the study.
Who cannot join
- Significant alcohol consumption (> 210 g/week in males and > 70 g/week in females)
- eGFR < 60 mL/min / 1.73m2 or patients on dialysis
- Hepato-biliary disorders: Cirrhosis, biliary obstruction, chronic cholecystitis, cholelithiasis, active or chronic active Hepatitis B or hepatitis C, autoimmune liver diseases
- Medical conditions including stroke, Alzheimer's disease, tuberculosis, Ischemic Heart Disease (IHD), Deep Vein Thrombosis (DVT), pancreatitis, inflammatory rheumatic diseases, cancer or any disorder that may potentially impact the outcome measures
- Patients on drugs potentially associated with NAFLD such as amiodarone, methotrexate, perhexiline, estrogens, tamoxifen, nifedipine, diltiazem, chloroquine and other hepatotoxic agents as per the discretion of the study investigator.
- Medications for disease conditions (e.g., HIV-1, HBV, or HCV infection, active cancer, transplantation are also excluded from the study.
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- Subjects on anti TNF therapies, other biologicals and probiotics
- Subjects on Thiazolidinediones (TZDs), Saroglitazar, Atazanavir, Indinavir, Ketoconazole, Valproic acid, Silybum marianum, Valeriana officinalis and hepatoprotective plants / Traditional medicine formulations / natural products.
- Subjects on medications that may affect glucose metabolism such as corticosteroids, opiates, barbiturates and anticoagulants.
- Any disorder or clinically significant finding that may potentially impact the outcome measures as per the discretion of the study investigator.
- Pregnant and lactating women.
- Patients with a history of serious drug allergies (such as anaphylactic shock)
- Not willing to provide written informed consent
- Females unwilling to use any form of contraception during the trial.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
India6 sites
PGIMER
Chandigarh, Chandigarh, 160012
King George 's Medical University
Chowk, Lucknow, 226003
All India Institute of Medical Sciences
Delhi, NEW DELHI, 110029
King Edward Memorial Hospital
Mumbai, Maharashtra, 400012
Nizam's Institute of Medical Sciences
Panjagutta, Hyderabad, 500082
Institute of Liver and Biliary Sciences
Vasant Kunj, NEW DELHI, 110070
About this study
Official title: A Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled, Interventional Study on Efficacy and Safety of Standardized Fraction of Picrorhiza Kurroa Royal Ex Benth (Picroliv®) for 24 Weeks in the Management of Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a Phase III, multicentre, randomized, double-blind, placebo-controlled, interventional study designed to evaluate the efficacy and safety of a standardized fraction of Picrorhiza kurroa Royal Ex Benth (Picroliv®) in adults with Non-Alcoholic Fatty Liver Disease (NAFLD).
A total of 170 adults aged 18-60 years with uncomplicated NAFLD (fibrosis stage up to F2) will be randomized in a 2:1 ratio to receive either Picroliv 100 mg capsules twice daily or matching placebo, in addition to standard of care, for a treatment duration of 24 weeks. Standard of care includes dietary and lifestyle modifications, exercise recommendations, and management of comorbid conditions as per routine clinical practice.
The study aims to assess the efficacy of Picroliv in improving hepatic and metabolic parameters and to evaluate its safety profile compared with placebo. Participants will be followed for a total study duration of 48 weeks. The trial will be conducted across six clinical sites in India.
Read the detailed description
Non-Alcoholic Fatty Liver Disease (NAFLD) is a highly prevalent metabolic liver disorder with limited pharmacological treatment options. Lifestyle modification remains the mainstay of management, highlighting the need for safe and effective therapeutic agents.
Picroliv®, a standardized ethanolic extract of the roots and rhizomes of Picrorhiza kurroa, has demonstrated hepatoprotective, antioxidant, and anti-inflammatory properties in preclinical studies and early clinical investigations.
This Phase III, multicentre, randomized, double-blind, placebo-controlled, two-arm interventional study is designed to evaluate the efficacy and safety of Picroliv in adults diagnosed with uncomplicated NAFLD (fibrosis stage up to F2). Eligible participants aged 18-60 years will be randomized in a 2:1 ratio to receive either Picroliv 100 mg capsules twice daily or matching placebo, in addition to standard of care, for 24 weeks.
Standard of care includes dietary counseling, exercise recommendations, and management of associated comorbidities as per routine clinical practice. Participants will be followed for a total study duration of 48 weeks. The study will be conducted at six clinical centers in India.
- Conditions
- Non Alcholic Fatty Liver Disease
- Being tested
- Picroliv, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicrolivDrug
Participants will receive Picroliv 100 mg capsules twice daily (after meals) for 24 weeks, in addition to standard of care, which includes dietary counseling, exercise recommendations, and management of comorbid conditions as per routine clinical practice.
PlaceboOther
Participants will receive matching placebo capsules twice daily (after meals) for 24 weeks, in addition to standard of care, which includes dietary counseling, exercise recommendations, and management of comorbid conditions as per routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Picroliv + Standard of Care Receives: Drug: Picroliv |
| Placebo Comparator arm | Placebo comparator | Placebo + Standard of Care Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic fat fraction
Measured as the change from baseline in hepatic fat fraction (%) assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) at Week 24.
Measured: Baseline to Week 24
Secondary outcomes (12)
Change in liver stiffness
Change from baseline in liver stiffness measurement assessed by transient elastography at Week 24.
Measured: Baseline to Week 24
Change in Serum Alanine Aminotransferase (ALT)
Change from baseline in serum alanine aminotransferase (ALT) levels to Week 24, and comparison of the mean change between treatment groups.
Measured: Baseline to Week 24
Change in Fasting Plasma Glucose
Change from baseline in fasting plasma glucose levels at Week 24 and comparison of the mean change between treatment groups.
Measured: Baseline to Week 24
Change in fibrosis score
Change from baseline in liver fibrosis assessed by transient elastography (FibroScan®) at Week 24. Transient elastography measures liver stiffness in kilopascals (kPa), which reflects the degree of liver fibrosis. Liver stiffness values typically range from ~2 to 75 kPa, with higher values indicating greater liver stiffness and more severe fibrosis.
Measured: Baseline to Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of participants experiencing at least one treatment-emergent adverse event (TEAE) during the study period.
Measured: Baseline to Week 48
Change in Serum Aspartate Aminotransferase (AST)
Change from baseline in serum aspartate aminotransferase (AST) levels to Week 24, and comparison of the mean change between treatment groups.
Measured: Baseline to Week 24
Change in Glycated Hemoglobin (HbA1c)
Change from baseline in glycated hemoglobin (HbA1c) levels at Week 24 and comparison of the mean change between treatment groups.
Measured: Baseline to Week 24
Change in Total Cholesterol
Change from baseline in total cholesterol levels at Week 24 and comparison of the mean change between treatment groups.
Measured: Baseline to Week 24
Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Change from baseline in LDL-C levels at Week 24 and comparison of the mean change between treatment groups.
Measured: Baseline to Week 24
Change in High-Density Lipoprotein Cholesterol (HDL-C)
Change from baseline in HDL-C levels at Week 24 and comparison of the mean change between treatment groups.
Measured: Baseline to Week 24
Change in Triglycerides
Change from baseline in triglyceride levels at Week 24 and comparison of the mean change between treatment groups.
Measured: Baseline to Week 24
Severity of Treatment-Emergent Adverse Events (TEAEs)
Severity of treatment-emergent adverse events (TEAEs) will be assessed and graded using the Common Terminology Criteria for Adverse Events (CTCAE) developed by the U.S. National Cancer Institute. The CTCAE grading system ranges from Grade 1 to Grade 5, where Grade 1 = Mild adverse event, Grade 2 = Moderate adverse event, Grade 3 = Severe adverse event, Grade 4 = Life-threatening or disabling adverse event, and Grade 5 = Death related to the adverse event. Higher grades indicate greater severity and worse clinical outcomes.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start13 Aug 2024
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcholic Fatty 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Vivek Bhosale, Study director, CDRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452744
- Sponsor's protocol ID
- BIAG-CSP-063
- Other IDs
- CDRI-ICMR-6/2021
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled, Interventional Study on Efficacy and Safety of Standardized Fraction of Picrorhiza Kurroa Royal Ex Benth (Picroliv®) for 24 Weeks in the Management of Non-Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT07452744
- Acronym / sponsor ID
- BIAG-CSP-063
- Conditions
- Non Alcholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Bioagile Therapeutics Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 5 Mar 2026 (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.
This is a Phase III, multicentre, randomized, double-blind, placebo-controlled, interventional study designed to evaluate the efficacy and safety of a standardized fraction of Picrorhiza kurroa Royal Ex Benth (Picroliv®) in adults with Non-Alcoholic Fatty Liver Disease (NAFLD).
A total of 170 adults aged 18-60 years with uncomplicated NAFLD (fibrosis stage up to F2) will be randomized in a 2:1 ratio to receive either Picroliv 100 mg capsules twice daily or matching placebo, in addition to standard of care, for a treatment duration of 24 weeks. Standard of care includes dietary and lifestyle modifications, exercise recommendations, and management of comorbid conditions as per routine clinical practice.
The study aims to assess the efficacy of Picroliv in improving hepatic and metabolic parameters and to evaluate its safety profile compared with placebo. Participants will be followed for a total study duration of 48 weeks. The trial will be conducted across six clinical sites in India.
Detailed description
Non-Alcoholic Fatty Liver Disease (NAFLD) is a highly prevalent metabolic liver disorder with limited pharmacological treatment options. Lifestyle modification remains the mainstay of management, highlighting the need for safe and effective therapeutic agents.
Picroliv®, a standardized ethanolic extract of the roots and rhizomes of Picrorhiza kurroa, has demonstrated hepatoprotective, antioxidant, and anti-inflammatory properties in preclinical studies and early clinical investigations.
This Phase III, multicentre, randomized, double-blind, placebo-controlled, two-arm interventional study is designed to evaluate the efficacy and safety of Picroliv in adults diagnosed with uncomplicated NAFLD (fibrosis stage up to F2). Eligible participants aged 18-60 years will be randomized in a 2:1 ratio to receive either Picroliv 100 mg capsules twice daily or matching placebo, in addition to standard of care, for 24 weeks.
Standard of care includes dietary counseling, exercise recommendations, and management of associated comorbidities as per routine clinical practice. Participants will be followed for a total study duration of 48 weeks. The study will be conducted at six clinical centers in India.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: PicrolivPicroliv + Standard of Care |
| Placebo Comparator arm | Placebo comparator | Other: PlaceboPlacebo + Standard of Care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 18- 60 years
- Sex: Both males and females
- Patients showing presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at screening.
- Liver enzymes normal or above the ULN (upper limit of normal range) but less than 3 times
- Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 109/L, and a white blood cell count ≥ 3.0 x 109/L
Key exclusion criteria (14 listed)
- Significant alcohol consumption (> 210 g/week in males and > 70 g/week in females)
- eGFR < 60 mL/min / 1.73m2 or patients on dialysis
- Hepato-biliary disorders: Cirrhosis, biliary obstruction, chronic cholecystitis, cholelithiasis, active or chronic active Hepatitis B or hepatitis C, autoimmune liver diseases
- Medical conditions including stroke, Alzheimer's disease, tuberculosis, Ischemic Heart Disease (IHD), Deep Vein Thrombosis (DVT), pancreatitis, inflammatory rheumatic diseases, cancer or any disorder that may potentially impact the outcome measures
- Patients on drugs potentially associated with NAFLD such as amiodarone, methotrexate, perhexiline, estrogens, tamoxifen, nifedipine, diltiazem, chloroquine and other hepatotoxic agents as per the discretion of the study investigator.
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 |
|---|---|---|
| PicrolivParticipants will receive Picroliv 100 mg capsules twice daily (after meals) for 24 weeks, in addition to standard of care, which includes dietary counseling, exercise recommendations, and management of comorbid conditions as per routine clinical practice. | Drug | Experimental arm |
| PlaceboParticipants will receive matching placebo capsules twice daily (after meals) for 24 weeks, in addition to standard of care, which includes dietary counseling, exercise recommendations, and management of comorbid conditions as per routine clinical practice. | Other | Placebo Comparator arm |
Primary outcome
Change in hepatic fat fraction
Time frame: Baseline to Week 24
Measured as the change from baseline in hepatic fat fraction (%) assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) at Week 24.
12 secondary outcomes
Change in liver stiffness
Time frame: Baseline to Week 24
Change in Serum Alanine Aminotransferase (ALT)
Time frame: Baseline to Week 24
Change in Fasting Plasma Glucose
Time frame: Baseline to Week 24
Change in fibrosis score
Time frame: Baseline to Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline to Week 48
Change in Serum Aspartate Aminotransferase (AST)
Time frame: Baseline to Week 24
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline to Week 24
Change in Total Cholesterol
Time frame: Baseline to Week 24
Change in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline to Week 24
Change in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline to Week 24
Change in Triglycerides
Time frame: Baseline to Week 24
Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline to Week 48
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 12 Mar 2026.
- 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.
Dr Vivek Bhosale study director
CDRI
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picroliv in people with Non Alcholic Fatty Liver Disease, run by Bioagile Therapeutics Pvt. Ltd. at 6 sites 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 8 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hepatic fat fraction (time frame: Baseline to Week 24). 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 12 Mar 2026.