Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
Emami Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients greater than 18 years old of either sex with one or more clinical symptoms like fatigue, nausea, anorexia, abdominal pain or discomfort, muscle cramps, jaundice, or any other symptoms with a history suggestive of mild to moderate hepatic disorder like ALD, which is characterized with a history of persistent alcohol intake and with liver function tests (LFT) suggestive of liver disease. 2. MASLD Metabolic dysfunction-associated steatotic liver disease (patients with a history suggestive of impaired metabolic function) 3. DIH (patients with the specific history of drug intake attributed to causing liver injury like anti tubercular, antiretroviral therapies etc.) 4. Hepatitis (patients with elevated LFT suggestive of hepatitis) will be enrolled in the study as per protocol defined eligibility criteria. 5. Patients of child-bearing potential were enrolled only if they agreed to use adequate and validated contraception during the study period. 6. Patients willing to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients suffering from severe hepatic conditions or complications like hepatocellular carcinoma, chronic hepatitis (hepatitis B or hepatitis C), portal hypertension, splenomegaly, hepatic encephalopathy, confusion, swelling or bleeding from veins, fluid accumulation in the abdomen, non-alcoholic steatohepatitis with cirrhosis as well as those undergoing active treatment for alcohol withdrawal syndrome, or those with ongoing treatment for CLD will be excluded from the study. 2. Patients with normal LFT or those with highly elevated LFT defined by alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than 5 times the upper limit for normal (ULN). 3. Patients with compromised hematological parameters (total white blood cells less than 3000 cells per mm3, absolute neutrophils less than 1500 cells per mm3, platelets less than 100000 per mm3) or patients with serum creatinine more than 2 mg per dL or creatinine clearance less than 60 mL per minute (based on Modification of Diet in Renal Disease (MDRD)) at screening, will also be excluded from the study. 4. The study will also excluded pregnant or lactating women and patients. 5. Participants with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and or systolic blood pressure more than or equal to 180 mmHg). 6. Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation. 7. Participants who are severe smokers and drinkers. 8. Received an investigational or product or participated in an investigational study within a period of 30 days prior to receiving study medication. 9. A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders. 10. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Sponsor physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Change from Baseline to EOS in Clinical Signs and Symptoms (Fatigue/Tiredness/Weakness, Nausea, Anorexia, Abdominal pain/Abdominal discomfort, Muscle cramp/Muscle Spasm, Jaundice) b) Change in Average Percent Reduction in LFT Values for Patients, who had Abnormal Values from Baseline to EOS c) Patient-wise Shift (Number and Percentage) from Abnormal to Normal Values in LFT from Baseline to EOSTimepoint: Baseline and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Change in complete blood Count, FBS, lipid profile, renal function tests (Urea, Creatinine) from Baseline to EOS. b) Change in FBS levels in arm 1 Zandu Livotrit (LIVITAL) Syrup from Baseline, Day 7, Day 15, Day 30 to EOS. c) Change in USG & Fibro scan levels from Baseline to EOS. d) Improvements in CLDQ (chronic liver disease questionnaire) scores in Patients from Baseline to EOSTimepoint: Baseline, Day 7, Day 15, Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactYogendra Kumar Choudhary
Sapthagiri Institute of Medical Sciences & Research Centre (SIMSRC)
Outcome results
None listed