Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558669
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Effect of Sugarcane Juice on Liver Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Sugarcane Juice on Liver Patients
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate the potential benefits of sugarcane juice on liver health in patients who are suffering from liver-related conditions We hypothesize that regular consumption of sugarcane juice may improve liver function and alleviate symptoms in patients with liver disease Patients participating in this study will consume a specified amount of sugarcane juice daily for 90 days and their liver health will be monitored to assess any improvements This study could help identify a natural accessible treatment option to support liver health in patients with liver disease potentially improving their quality of life
Detailed Description:
This randomized controlled trial RCT is designed to evaluate the impact of sugarcane juice on liver health in patients diagnosed with liver-related conditions including cirrhosis hepatitis and fatty liver disease The study aims to assess whether sugarcane juice administered in varying dosages has a therapeutic effect on liver enzyme levels and overall liver function
Study Design
This is an interventional study using a randomized controlled trial RCT design Participants will be randomly assigned to one of four groups three treatment groups and one control group The treatment groups will receive daily doses of sugarcane juice at 170mL 230mL and 300mL respectively along with their prescribed medicine for a duration of three months The control group will receive no sugarcane juice but will continue their prescribed medication regimen
Intervention Details
Control Group Receives no sugarcane juice only prescribed medication Group 1 Receives 170mL of sugarcane juice daily along with prescribed medication
Group 2 Receives 230mL of sugarcane juice daily along with prescribed medication
Group 3 Receives 300mL of sugarcane juice daily along with prescribed medication
Duration of the Study
The study will span three months during which participants liver health will be monitored at regular intervals
Outcome Measures
Primary Outcome Measures
Levels of liver enzymes Alanine Aminotransferase ALT Aspartate Aminotransferase AST Alkaline Phosphatase ALP and Total Bilirubin
Secondary Outcome Measures
Changes in liver-related symptoms including jaundice abdominal pain fatigue and nausea
Sample Size
The study will enroll a total of 400 participants The participants will be divided into four groups
Control Group 100 participants Group 1 100 participants Group 2 100 participants Group 3 100 participants
Inclusion and Exclusion Criteria
Inclusion Criteria
Patients diagnosed with liver disease including but not limited to cirrhosis hepatitis or fatty liver disease
Age group 20-60 years Symptoms criteria based on liver disease include jaundice abdominal pain fatigue nausea and elevated liver enzymes ALT AST as per standard diagnostic criteria
Exclusion Criteria
Patients younger than 20 years or older than 60 years Patients with a history of other chronic conditions that may interfere with liver function such as chronic kidney disease or heart failure
Patients who have undergone liver transplantation Patients currently participating in another clinical trial related to liver disease
Pregnant or breastfeeding women
Statistical Analysis Plan
The data will be analyzed using SPSS version 27 A Two-Way ANOVA will be used to compare the effects of different dosages of sugarcane juice on liver enzyme levels across the treatment groups and control group Post hoc analysis will be conducted using Tukeys Honest Significant Difference HSD test to identify specific group differences
Quality Assurance Measures
Data Validation Rigorous input checks automated testing and manual reviews will be implemented to ensure data accuracy
Site Monitoring Real-time monitoring tools will be employed to track site performance and swiftly identify any data issues
Auditing Regular audits will be performed to ensure compliance with the study protocol and to maintain the integrity of the data
Handling Missing Data
Data Imputation Both simple and advanced methods will be employed to impute missing data ensuring the robustness of the dataset
Data Cleansing Consistency checks and outlier detection methods will be implemented to correct data errors
User Feedback Tools will be provided to allow users to report and correct missing or inconsistent data promptly
Study Design
This is an interventional study using a randomized controlled trial RCT design Participants will be randomly assigned to one of four groups three treatment groups and one control group The treatment groups will receive daily doses of sugarcane juice at 170mL 230mL and 300mL respectively along with their prescribed medicine for a duration of three months The control group will receive no sugarcane juice but will continue their prescribed medication regimen
Intervention Details
Control Group Receives no sugarcane juice only prescribed medication Group 1 Receives 170mL of sugarcane juice daily along with prescribed medication
Group 2 Receives 230mL of sugarcane juice daily along with prescribed medication
Group 3 Receives 300mL of sugarcane juice daily along with prescribed medication
Duration of the Study
The study will span three months during which participants liver health will be monitored at regular intervals
Outcome Measures
Primary Outcome Measures
Levels of liver enzymes Alanine Aminotransferase ALT Aspartate Aminotransferase AST Alkaline Phosphatase ALP and Total Bilirubin
Secondary Outcome Measures
Changes in liver-related symptoms including jaundice abdominal pain fatigue and nausea
Sample Size
The study will enroll a total of 400 participants The participants will be divided into four groups
Control Group 100 participants Group 1 100 participants Group 2 100 participants Group 3 100 participants
Inclusion and Exclusion Criteria
Inclusion Criteria
Patients diagnosed with liver disease including but not limited to cirrhosis hepatitis or fatty liver disease
Age group 20-60 years Symptoms criteria based on liver disease include jaundice abdominal pain fatigue nausea and elevated liver enzymes ALT AST as per standard diagnostic criteria
Exclusion Criteria
Patients younger than 20 years or older than 60 years Patients with a history of other chronic conditions that may interfere with liver function such as chronic kidney disease or heart failure
Patients who have undergone liver transplantation Patients currently participating in another clinical trial related to liver disease
Pregnant or breastfeeding women
Statistical Analysis Plan
The data will be analyzed using SPSS version 27 A Two-Way ANOVA will be used to compare the effects of different dosages of sugarcane juice on liver enzyme levels across the treatment groups and control group Post hoc analysis will be conducted using Tukeys Honest Significant Difference HSD test to identify specific group differences
Quality Assurance Measures
Data Validation Rigorous input checks automated testing and manual reviews will be implemented to ensure data accuracy
Site Monitoring Real-time monitoring tools will be employed to track site performance and swiftly identify any data issues
Auditing Regular audits will be performed to ensure compliance with the study protocol and to maintain the integrity of the data
Handling Missing Data
Data Imputation Both simple and advanced methods will be employed to impute missing data ensuring the robustness of the dataset
Data Cleansing Consistency checks and outlier detection methods will be implemented to correct data errors
User Feedback Tools will be provided to allow users to report and correct missing or inconsistent data promptly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None