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

NCT06256926 | Completed Phase 2 DMC

• 2 other identifiers: CSI2003CSI2003, Version 2.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Fatty Liver Without Mention of Alcohol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• AST to Platelet Ratio Index (APRI)

  60 Days

• Fibrosis score (kilopascals (kPa))

  60 Days

• Controlled Attenuation Parameter (CAP) score (decibels per meter (dB/m))

  60 Days

• Change in lipid profile from baseline to day 60

  60 Days

• Change in liver enzymes ALT and AST from baseline to day 60

  60 Days

Study Arms (2)

Drug Product

ACTIVE COMPARATOR

Test Product: Curcuvail® 250 mg capsule

Drug: Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids)

Placebo Product

PLACEBO COMPARATOR

Placebo Product

Drug: Placebo product

Interventions

Test Product: Curcuvail® 250mg capsule (Curcuma longa Extractcontaining 35% Curcuminoids) DRUG

Curcuma longa Extract containing 35% Curcuminoids Dose: One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days

Also known as: Curcuvail® 250 mg capsule

Drug Product

Placebo product DRUG

Placebo product Dose:One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days

Also known as: Placebo Comparator: Placebo Product

Placebo Product

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• COD Research Private Ltd: lead

Study Sites (1)

Cod Research Pvt Ltd

Ahmedabad, Gujarat, 380060, India

Location

MeSH Terms

Interventions

Diarylheptanoids

Intervention Hierarchy (Ancestors)

Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Mr. Nimesh Parekh, M.Sc.

  Chief Operating Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: February 13, 2024
• Study Start: January 8, 2021
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)