Health Condition 1: K77- Liver disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: CurcuBoost capsule: Dose- 1 capsule 500 mg of CurcuBoost to be taken once a day, orally with plain water after meal for 84 +/- 3 days or 12 Weeks.
Control Intervention1: Standard of Car
Sponsors
Sunpure Extracts Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 75 years 2. Diagnosis of Liver Dysfunction: Biochemical evidence of liver dysfunction, including elevated liver enzymes (e.g., ALT, AST, ALP, GGT, and/or bilirubin) Serum total bilirubin level greater than ULN &less than or equal to 3 times ULN. AST or ALT or ALP greater than 3 times ULN &less than or equal to 5 times ULN. GGT greater than ULN & less than or equal 2 times ULN 3.Chronic liver conditions, such as: Non-alcoholic fatty liver disease (NAFLD) Non-alcoholic steatohepatitis (NASH) Chronic hepatitis (e.g., hepatitis B, C, or autoimmune hepatitis) Early liver fibrosis or cirrhosis (confirmed via imaging like elastography or biomarker indices like FIB-4 or APRI) Alcohol-related liver disease (if participants are not actively consuming alcohol). 4.Stable Health: Stable liver function and no active acute liver disease (e.g., no acute viral hepatitis or decompensated cirrhosis). No significant uncontrolled comorbidities such as uncontrolled diabetes, hypertension, or cardiovascular disease. 5.Informed Consent: Ability to provide written informed consent and adhere to study protocol. 6.Willingness to comply: Willingness to adhere to study requirements, including taking curcumin and attending all follow-up visits
Exclusion criteria
Exclusion criteria: A subject will be considered unsuitable for the study if they meet any one of the following criteria: 1.Severe Liver Disease: Decompensated cirrhosis (e.g., presence of ascites, variceal bleeding, hepatic encephalopathy). End-stage liver disease (e.g., MELD score greater than 15, liver transplant candidates). Acute liver failure or severe acute hepatotoxicity. 2.Other Major Medical Conditions: Active cancer, except for non-invasive skin cancers (e.g., basal cell carcinoma). Severe cardiovascular diseases, such as recent myocardial infarction or congestive heart failure require hospitalization. 3.Pregnancy and Lactation: Pregnant or breastfeeding women. Women of childbearing potential not using effective contraception. 4.Drug and Substance Use: Active alcohol or drug abuse (substance abuse that may interfere with liver function or study compliance). Use of hepatotoxic medications, including certain chemotherapy agents, and anticoagulants (unless stable and managed). Use of curcumin or turmeric supplements within 30 days prior to enrollment. 5.Gastrointestinal Disorders: History of active gastrointestinal disease (e.g., peptic ulcer disease, inflammatory bowel disease, gastrointestinal bleeding), which could affect curcumin absorption or safety. 6.Allergy/Intolerance: Known hypersensitivity to curcumin, turmeric, or any study-related components, such as pipeline. 7.Comorbidities and Medications: Use of immunosuppressive drugs or chronic use of NSAIDs or other anti-inflammatory medications that could confound the effects of curcumin. History of non-compliance with medical treatments or clinical study protocols. 8.Other Confounding Factors: Participation in other clinical trials that may interfere with the outcomes of this study. Patients who are unlikely to complete the study (e.g., those with mental or psychological conditions that would prevent adherence).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary measure of efficacy would be the change in serum liver enzyme levels (ALT, AST, ALP, GGT) from baseline to the end of the studyTimepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are to Changes in Liver Disease Quality of Life (LDQOL) score from baseline to the end of the study (Week 12) and Adverse events and severe adverse events throughout the studyTimepoint: Week 12 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
Tulsi Multispeciality Hospital
Outcome results
None listed