Fatty Liver Without Mention of Alcohol
Conditions
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).
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.
Interventions
DRUGTest 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
DRUGPlacebo product
Placebo product Dose:One capsule Frequency: Twice Daily Route of administration: Oral Duration of therapy: 60Days
Sponsors
COD Research Private Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NAFLD grading based on liver USG from baseline to day 60. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fibrosis score (kilopascals (kPa)) | 60 Days | 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 |
| Controlled Attenuation Parameter (CAP) score (decibels per meter (dB/m)) | 60 Days | CAP score (dB/m) as evaluated by FibroScan and assessed as change from baseline to day 60. |
| AST to Platelet Ratio Index (APRI) | 60 Days | APRI score assessed as change from baseline to day 60 |
| Change in liver enzymes ALT and AST from baseline to day 60 | 60 Days | Change in liver enzymes ALT (IU/L) and AST (IU/L) from baseline to day 60 |
| Number (Frequency & percentage of patients) and type (severity and causality assessment) of AE (Adverse Event) and SAE (Serious Adverse Event). | Till 67 days from day of randomization | AE (Adverse Event) and SAE (Serious Adverse Event) were evaluated during the study. |
| Change in lipid profile from baseline to day 60 | 60 Days | 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 |
Countries
India
Outcome results
None listed