A Clinical Study of Curcuvail® in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

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).

Study Overview

• Status: Completed
• Conditions: Fatty Liver Without Mention of Alcohol
• Intervention / Treatment: Drug: Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids); Drug: Placebo product

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380060
      • Cod Research Pvt Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent prior to any study-related activities being performed.
2. Able and willing to comply with the protocol, including availability for all scheduled study visits.
3. Male and Female patients aged between 18 years to 70, both inclusive.
4. Patients diagnosed with fatty liver (grades 1-3) based on liver ultrasonography.
5. 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.
6. 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).

Exclusion Criteria:

1. Hypersensitivity to Curcuvail or related class of drugs or to any of the excipients of the formulation.
2. Fatty liver secondary to alcohol consumption.
3. 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
4. Addicted Alcoholics and- or drug abusers.
5. History or presence of coronary, renal, pulmonary and thyroid disease.
6. AST and ALT more than 5 times ULN; Serum bilirubin more than ULN and Platelet Count less than 95,000 per microliter.
7. Patients using hypolipidemic medications as well as any drug known to affect hepatic function 4 weeks prior to randomization.
8. Difficulty in swallowing and retaining oral formulation.
9. Known HBs Ag positive, Anti HCV and HIV positive, hereditary defects of iron, copper and alpha- 1 antitrypsin deficient patients.
10. Hypothyroidism, obstructive sleep apnoea, total parenteral nutrition, short bowel syndrome, pancreatoduodenal resection which are secondary causes of NAFLD.
11. 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.
12. Participation in any other clinical study within 30 days before the first dose of Investigational Product.
13. Pregnant or Lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Product	Drug: Placebo product; Placebo product Dose:One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days; Other Names: Placebo Comparator: Placebo Product
Active Comparator: Drug Product; Test Product: Curcuvail® 250 mg capsule	Drug: Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids); Curcuma longa Extract containing 35% Curcuminoids Dose: One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days; Other Names: Curcuvail® 250 mg capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AST to Platelet Ratio Index (APRI)	APRI score assessed as change from baseline to day 60	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	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.	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	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	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.	Till 67 days from day of randomization

Collaborators and Investigators

• Sponsor: COD Research Private Ltd
• Investigators: Study Director: Mr. Nimesh Parekh, M.Sc., Chief Operating Officer

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): November 25, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Turmeric extract
• Other Study ID Numbers: CSI2003; CSI2003, Version 2.0 (Other Identifier: K Patel Phyto Extractions Pvt. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No