An Open Label, Randomized, single center Clinical Trial to evaluate the efficacy, safety and tolerability of CurcuBoost® when administered with standard of care and compared to standard of care alone in subjects with deranged liver function
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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 study
研究概览
简要总结
This open-label, randomized, single-center clinical trial aims to assess the potential benefits of CurcuBoost® when added to the standard of care in subjects with deranged liver function. By comparing outcomes with standard of care alone, this study seeks to establish whether CurcuBoost® can provide additional therapeutic benefits, including improvements in liver function parameters, quality of life, and overall safety and tolerability in individuals with liver dysfunction. 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 study (Week 12) and the Secondary measures 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 study.
| Arm I |
CurcuBoost + SOC, 1 capsule 500 mg to be taken once a day, orally with plain water after meal for 84+ 3 days or 12 Weeks.
| Arm II |
SOC, Subjects in comparator arm will receive allowed Standard of Care as per protocol and in judgment of Investigator for 84 + 3 days or 12 Weeks.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18–75 years
- •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.
排除标准
- •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).
结局指标
主要结局
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 study
时间窗: Week 12
次要结局
- 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 study(Week 12)
研究者
Dr Dipti Gupta
Tulsi Multispeciality Hospital