An Open-Label Study To Evaluate The Safety And Efficacy Of Liver Detox Formula In Fatty Liver Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. Chronic Liver Disease Questionnaire (CLDQ)
研究概览
简要总结
INTRODUCTION: Fatty Liver Disease (FLD) iis a prevalent condition marked by the accummulaton of fat in liver cells, which can lead to inflammation and liver damage. FLD is categorised into two primary types: Alcoholic Fatty Liver Disease (AFLD) due to excessive alcohol consumption and Non-Alcoholic Fatty Liver Disease (NAFLD), commonly associated with metabolic conditions like obesity, type 2 diabetes and sedentary lifestyle. Both of them if untreated can lead to serious liver issues such as fibrosis, cirrhosis and hepatocellular carcinoma. Currently, no specific drugs are approved to treat FLD. Liver Detox Formula is a traditional herbal supplement believed to enhance liver health. This study was planned to gather clinical data to prove the effectiveness of Liver Detox Formula in the treatment of AFLD and NAFLD.
PURPOSE: The primary purpose of the study was to evaluate the safety and efficacy of LIver Detox Formula as a complementary treatment for AFLD and NAFLD. The study aimed at improving liver-related symptoms and enhancing the Quality of Life in patients using a non-invasive patient-centered approach.
RESULTS: A total of 50 participants were enrolled, out of which 45 completed the study (25 male and 20 female participants). All the participants had normal vital signs throughout the study.
The Efficacy analysis was conducted to assess the impact of Liver Detox Formula on liver health over a 90-day treatment period.
Primary Efficacy Endpoints: Chronic Liver Disease Questionnaire (CLDQ) outcome revealed abdominal symptoms, fatigue, Systemic symptoms, Daily Limitations, Psychological Worries and Emotional Distress all improved significantly by 82.44%. P-values across all CLDQ domains ranged from 1.17E-57 to 2.29E-47 confirming extremely high statistical significance.
Fatigue Sererity Scale (FSS): Fatigue severity improved by 85% from a baseline mean of 6.6 to 1.5 by Visit 4. P-value of 8.44E-62 indicated significant reduction in fatigue levels. The low standard deviation values supported improvement consistency across participants.
Secondary Efficacy Endpoints: Symptom Specific Checklist - Significant improvement in gastrointestinal symptoms with an average of over 84% with P-value of 9.96E-35 indicating robust treatment effect with clinical significance.
Chronic Disease Severity Assessment - Clinician-rated scores showed a >90% from visit 1 to 4 across all domains. P-value of 2.0E-52 confirmed uniform and substantial clinical recovery across the patient population.
Clinician-Assessed Symptom Improvement - A 73.46% improvement noted in composite symptom ratings between Visit 2 and Visit 4. P-value of 1.02E-34 supported the sustained and reliable perception of recoveery by the clinical evaluators.
No SAEs were reported and the product was well tolerated. There were no treatment discontinuations due to adverve events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients already diagnosed with Alcoholic Fatty Liver Disease (AFLD) or Non-Alcoholic Fatty Liver Disease (NAFLD) confirmed through clinical evaluation (e.g., imaging or medical history).
- •Willingness to Participate.
- •Participants must be willing and able to provide written informed consent and comply with the study requirements, including completing all scheduled visits and questionnaires.
- •Stable Medical Condition.
- •Participants should have a stable medical condition that would not interfere with the study treatment or outcome evaluations.
排除标准
- •Severe Liver Disease.
- •Patients with severe liver diseases, such as cirrhosis, hepatic failure, or hepatocellular carcinoma.
- •Pregnancy or Breastfeeding.
- •Pregnant or breastfeeding women.
- •Other Liver Conditions.
- •Patients diagnosed with liver conditions unrelated to fatty liver disease, including but not limited to Hepatitis B, Hepatitis C, or HIV. 4.Use of Other Investigational Drugs.
- •Participants currently enrolled in another clinical study or using investigational drugs within 30 days prior to screening.
- •Severe Comorbidities.
- •Patients with severe comorbid conditions such as uncontrolled cardiovascular, renal, or hematological diseases that could interfere with the study results or pose an increased risk to the patient.
- •Substance Abuse.
- •Patients with a history of substance abuse (other than alcohol) or any medical condition that could affect compliance with the study protocol.
- •Non-compliance.
- •Patients unable or unwilling to comply with study procedures, including attending follow-up visits or completing questionnaires.
结局指标
主要结局
1. Chronic Liver Disease Questionnaire (CLDQ)
时间窗: Day 0, Day 30, Day 60 and Day 90
2. Fatigue Severity Scale (FSS)
时间窗: Day 0, Day 30, Day 60 and Day 90
次要结局
- 1. Improvement in Liver-Related Symptoms(2. Patient Satisfaction)
研究者
Dr BN Satish
RVS Ayurvedic Medical College, Hospital and Research Centre