Fatty Liver Without Mention of AlcoholPhase 2NAFLDNCT06256926
A Clinical Study of Curcuvail® in Patients With Non-alcoholic Fatty Liver Disease
A Phase 2 study testing Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids) in people with Fatty Liver Without Mention of Alcohol, run by COD Research Private Ltd at 1 site in India.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatty Liver Without Mention of Alcohol
- What is being tested?
- Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 8 Jan 2021to 25 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent prior to any study-related activities being performed.
- Able and willing to comply with the protocol, including availability for all scheduled study visits.
- Male and Female patients aged between 18 years to 70, both inclusive.
- Patients diagnosed with fatty liver (grades 1-3) based on liver ultrasonography.
- Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception.
- Female patients with negative urine pregnancy test (only for female who has not completed 1 year after menopause \& have not gone through hysterectomy or bilateral tubal ligation).
Who cannot join
- Hypersensitivity to Curcuvail or related class of drugs or to any of the excipients of the formulation.
- Fatty liver secondary to alcohol consumption.
- History of regular alcohol consumption exceeding 14 drinks per week for female subjects or 21 drinks per week for male subjects (1 drink - 5 ounce [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within the previous 6 months from screening
- Addicted Alcoholics and- or drug abusers.
- History or presence of coronary, renal, pulmonary and thyroid disease.
- AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count less than 95,000 per microliter.
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- Patients using hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization.
- Difficulty in swallowing and retaining oral formulation.
- Known HBs Ag positive, Anti HCV and HIV positive, hereditary defects of iron, copper and alpha- 1 antitrypsin deficient patients.
- Hypothyroidism, obstructive sleep apnoea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection which are secondary causes of NAFLD.
- Patient has condition or is in a situation which, in the investigator's opinion, may have put the patient at a significant risk, may have confounded study results, or may have interfered significantly with the patient's participation in the study.
- Participation in any other clinical study within 30 days before the first dose of Investigational Product.
- Pregnant or Lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Curcuvail® of K Patel Phyto Extractions Pvt. Ltd. in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular carcinoma (HCC).
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular carcinoma (HCC).
Currently there are no effective medications to cure NAFLD. Current treatments for NAFLD include weight reduction through lifestyle modification and exercise, insulin-sensitizing agents, lipid-lowering agents, and hepatoprotective drugs. However, the efficacy of these therapies is not satisfactory, some drugs may even induce liver toxicity. Thus, it is necessary to develop novel therapies that are effective and safe for the treatment of NAFLD.
Hence, K Patel Phyto Extractions Pvt. Ltd. has formulated Curcuvail®. Objective of the current study is to compare efficacy, safety and tolerability of test formulation Curcuvail® by administering the medications in the adult patients suffering from Non-alcoholic Fatty Liver Disease (NAFLD) and eligible to receive Curcuvail® as treatment.
- Conditions
- Fatty Liver Without Mention of Alcohol
- Being tested
- Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids), Placebo product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids)Drug
Also called Curcuvail® 250 mg capsule
Curcuma longa Extract containing 35% Curcuminoids Dose: One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days
Placebo productDrug
Also called Placebo Comparator: Placebo Product
Placebo product Dose:One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days
| Study group | Role | What they receive |
|---|---|---|
| Drug Product | Active comparator | Test Product: Curcuvail® 250 mg capsule Receives: Drug: Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids) |
| Placebo Product | Placebo comparator | Placebo Product Receives: Drug: Placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NAFLD grading based on liver USG from baseline to day 60.
NAFLD Grading:
Grade 0: Lack of fat accumulation Grade 1: Mild Increase in echogenicity with normal visualization of the diaphragm and intra-hepatic vessel borders.
Grade 2: Moderate increase in echogenicity with slightly impaired visualization of diaphragm and intra-hepatic vessel borders.
Grade 3: Severe increase in echogenicity with markedly impaired visualization of diaphragm, intra-hepatic vessel borders, and posterior portion of the right hepatic lobe.
Measured: 60 Days
Secondary outcomes (6)
AST to Platelet Ratio Index (APRI)
APRI score assessed as change from baseline to day 60
Measured: 60 Days
Fibrosis score (kilopascals (kPa))
Fibrosis score evaluated by FibroScan and assessed as change from baseline to day 60
Fibrosis score:
F0 to F1 (No liver scarring or mild liver scarring): 2 to 7 kPa F2 (Moderate liver scarring) : 7.5 to 10 kPa F3 (Severe liver scarring) : 10 to 14 kPa F4 (Advanced liver scarring (cirrhosis)): 14 kPa or higher
Measured: 60 Days
Controlled Attenuation Parameter (CAP) score (decibels per meter (dB/m))
CAP score (dB/m) as evaluated by FibroScan and assessed as change from baseline to day 60.
Measured: 60 Days
Change in lipid profile from baseline to day 60
Change in lipid profile [total cholesterol, high density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides represented as mg/dL] from baseline to day 60
Measured: 60 Days
Change in liver enzymes ALT and AST from baseline to day 60
Change in liver enzymes ALT (IU/L) and AST (IU/L) from baseline to day 60
Measured: 60 Days
Number (Frequency & percentage of patients) and type (severity and causality assessment) of AE (Adverse Event) and SAE (Serious Adverse Event).
AE (Adverse Event) and SAE (Serious Adverse Event) were evaluated during the study.
Measured: Till 67 days from day of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start8 Jan 2021
- Primary completion25 Nov 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver Without Mention of AlcoholStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- COD Research Private Ltd
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mr. Nimesh Parekh, M.Sc., Study director, Chief Operating Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256926
- Sponsor's protocol ID
- CSI2003
- Other IDs
- CSI2003, Version 2.0
- Acronym
- NAFLD
- Status last verified
- Feb 2024
- First submitted
- 8 Dec 2021
- Last updated
- 13 Feb 2024
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Curcuvail® of K Patel Phyto Extractions Pvt. Ltd. in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT06256926
- Acronym / sponsor ID
- NAFLD / CSI2003
- Conditions
- Fatty Liver Without Mention of Alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- COD Research Private LtdOther government
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 13 Feb 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.
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular carcinoma (HCC).
Detailed description
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease. It comprises a wide spectrum of disorders that range from simple steatosis to nonalcoholic steatohepatitis (NASH), advanced fibrosis, related cirrhosis, and even hepatocellular carcinoma (HCC).
Currently there are no effective medications to cure NAFLD. Current treatments for NAFLD include weight reduction through lifestyle modification and exercise, insulin-sensitizing agents, lipid-lowering agents, and hepatoprotective drugs. However, the efficacy of these therapies is not satisfactory, some drugs may even induce liver toxicity. Thus, it is necessary to develop novel therapies that are effective and safe for the treatment of NAFLD.
Hence, K Patel Phyto Extractions Pvt. Ltd. has formulated Curcuvail®. Objective of the current study is to compare efficacy, safety and tolerability of test formulation Curcuvail® by administering the medications in the adult patients suffering from Non-alcoholic Fatty Liver Disease (NAFLD) and eligible to receive Curcuvail® as treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Product | Active comparator | Drug: Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids)Test Product: Curcuvail® 250 mg capsule |
| Placebo Product | Placebo comparator | Drug: Placebo productPlacebo Product |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent prior to any study-related activities being performed.
- Able and willing to comply with the protocol, including availability for all scheduled study visits.
- Male and Female patients aged between 18 years to 70, both inclusive.
- Patients diagnosed with fatty liver (grades 1-3) based on liver ultrasonography.
- Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any two acceptable methods of contraception.
Key exclusion criteria (13 listed)
- Hypersensitivity to Curcuvail or related class of drugs or to any of the excipients of the formulation.
- Fatty liver secondary to alcohol consumption.
- History of regular alcohol consumption exceeding 14 drinks per week for female subjects or 21 drinks per week for male subjects (1 drink - 5 ounce [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within the previous 6 months from screening
- Addicted Alcoholics and- or drug abusers.
- History or presence of coronary, renal, pulmonary and thyroid disease.
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 |
|---|---|---|
| Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids)Also: Curcuvail® 250 mg capsuleCurcuma longa Extract containing 35% Curcuminoids Dose: One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days | Drug | Drug Product |
| Placebo productAlso: Placebo Comparator: Placebo ProductPlacebo product Dose:One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days | Drug | Placebo Product |
Primary outcome
Change in NAFLD grading based on liver USG from baseline to day 60.
Time frame: 60 Days
NAFLD Grading: Grade 0: Lack of fat accumulation Grade 1: Mild Increase in echogenicity with normal visualization of the diaphragm and intra-hepatic vessel borders. Grade 2: Moderate increase in echogenicity with slightly impaired visualization of diaphragm and intra-hepatic vessel borders. Grade 3: Severe increase in echogenicity with markedly impaired visualization of diaphragm, intra-hepatic vessel borders, and posterior portion of the right hepatic lobe.
6 secondary outcomes
AST to Platelet Ratio Index (APRI)
Time frame: 60 Days
Fibrosis score (kilopascals (kPa))
Time frame: 60 Days
Controlled Attenuation Parameter (CAP) score (decibels per meter (dB/m))
Time frame: 60 Days
Change in lipid profile from baseline to day 60
Time frame: 60 Days
Change in liver enzymes ALT and AST from baseline to day 60
Time frame: 60 Days
Number (Frequency & percentage of patients) and type (severity and causality assessment) of AE (Adverse Event) and SAE (Serious Adverse Event).
Time frame: Till 67 days from day of randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Mr. Nimesh Parekh, M.Sc. study director
Chief Operating Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids) in people with Fatty Liver Without Mention of Alcohol, run by COD Research Private Ltd 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 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: finished, as of the sponsor's last update on 13 Feb 2024. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NAFLD grading based on liver USG from baseline to day 60. (time frame: 60 Days). 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 13 Feb 2024.