Liver; Disease, InflammatoryNCT06558669
Effect of Sugarcane Juice on Liver Patients
A study testing Fresh Sugarcane juice in people with Liver; Disease, Inflammatory, run by Pir Mehr Ali Shah Arid Agriculture University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Liver; Disease, Inflammatory
- What is being tested?
- Fresh Sugarcane juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jul 2023to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with liver disease, Age group 20 to 60years Symptoms criteria based on liver disease include jaundice, abdominal pain, fatigue, nausea, and elevated liver enzymes (ALT, AST) as per standard diagnostic criteria.
Who cannot join
- Patients younger than 20 years or older than 60 years. Pregnant or breastfeeding women Patients who have undergone liver transplantation. Patients with a history of other chronic conditions that may interfere with liver function, such as chronic kidney disease or heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 Tukey's 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.
- Conditions
- Liver; Disease, Inflammatory
- Being tested
- Fresh Sugarcane juice
- Keywords
- Fresh Sugarcane juice, Liver diseases, Liver health status
- Medical subject headings
- Hepatitis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Sugarcane juiceOther
Fresh sugarcane juice in different doses will be given to liver patients for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | There are 100 participants in this arm and will only consume their prescribed medicines. |
| Treatment 1 | Experimental | There are 100 participants in this arm who will consume 170mL of fresh sugarcane juice and take their prescribed medicines. Receives: Other: Fresh Sugarcane juice |
| Treatment 2 | Experimental | There are 100 participants in this arm who will consume 230mL of fresh sugarcane juice and take their prescribed medicines. Receives: Other: Fresh Sugarcane juice |
| Treatment 3 | Experimental | There are 100 participants in this arm who will consume 300mL of fresh sugarcane juice and take their prescribed medicines. Receives: Other: Fresh Sugarcane juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Health Status
Liver health status will assessed through liver function tests including, ALT, AST, ALP, and Total Bilirubin in Phase 1.
Measured: ["1 Month" at study commencement (Phase 1)]
LIver Health Status
Liver health status will assessed through liver function tests including, ALT, AST, ALP, and Total Bilirubin in Phase 2 after completion of three month intervention
Measured: [Termination of Phase 2(intervention period), "3 Month"]
LIver Health Status
Liver health status will assessed through liver function tests including, ALT, AST, ALP, and Total Bilirubin in Phase 3 which is wash-out time
Measured: [Termination of Phase 3 (Washout period), "1 Month"]
Secondary outcomes (2)
Dietary Pattern Analysis
Dietary patterns will be analyzed using a Food Frequency Questionnaire (FFQ) to evaluate the patients' intake of various food groups. This will include an assessment of the frequency, portion sizes, and overall dietary diversity. The aim is to correlate dietary habits with the study's primary outcomes.
Measured: [Through studyy compeletion, an avaerage of 9 month]
Dietary Pattern Assessment
A Food Frequency Questionnaire (FFQ) will be administered to assess the dietary patterns of the patients. This questionnaire will capture the frequency, portion size, and types of food consumed over the study period. The collected data will be used to analyze the relationship between dietary patterns and the primary outcomes of the study.
Measured: [Through studyy compeletion, an avaerage of 9 month]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start10 Jul 2023
- Primary completion10 Feb 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver; Disease, InflammatoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- My study model is Parallel, as I want to check which dose of fresh sugarcane juice has the best effect on liver health status after the consumption of fresh sugarcane juice for 90days, for this, participants has been divided into, one control and three treatments groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pir Mehr Ali Shah Arid Agriculture University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naeem Mujahid, Pir Mehr Ali Shah Arid Agriculture University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558669
- Sponsor's protocol ID
- AAURwI
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sugarcane Juice on Liver Patients
- ClinicalTrials.gov ID
- NCT06558669
- Acronym / sponsor ID
- AAURwI
- Conditions
- Liver; Disease, Inflammatory
- Keywords
- Fresh Sugarcane juice, Liver diseases, Liver health status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Pir Mehr Ali Shah Arid Agriculture UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Tukey's 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- My study model is Parallel, as I want to check which dose of fresh sugarcane juice has the best effect on liver health status after the consumption of fresh sugarcane juice for 90days, for this, participants has been divided into, one control and three treatments groups
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –There are 100 participants in this arm and will only consume their prescribed medicines. |
| Treatment 1 | Experimental | Other: Fresh Sugarcane juiceThere are 100 participants in this arm who will consume 170mL of fresh sugarcane juice and take their prescribed medicines. |
| Treatment 2 | Experimental | Other: Fresh Sugarcane juiceThere are 100 participants in this arm who will consume 230mL of fresh sugarcane juice and take their prescribed medicines. |
| Treatment 3 | Experimental | Other: Fresh Sugarcane juiceThere are 100 participants in this arm who will consume 300mL of fresh sugarcane juice and take their prescribed medicines. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with liver disease, Age group 20 to 60years Symptoms criteria based on liver disease include jaundice, abdominal pain, fatigue, nausea, and elevated liver enzymes (ALT, AST) as per standard diagnostic criteria.
Key exclusion criteria (1 listed)
- Patients younger than 20 years or older than 60 years. Pregnant or breastfeeding women Patients who have undergone liver transplantation. Patients with a history of other chronic conditions that may interfere with liver function, such as chronic kidney disease or heart failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh Sugarcane juiceFresh sugarcane juice in different doses will be given to liver patients for 90 days | Other | Treatment 1, Treatment 2, Treatment 3 |
Primary outcome
Liver Health Status
Time frame: ["1 Month" at study commencement (Phase 1)]
Liver health status will assessed through liver function tests including, ALT, AST, ALP, and Total Bilirubin in Phase 1.
LIver Health Status
Time frame: [Termination of Phase 2(intervention period), "3 Month"]
Liver health status will assessed through liver function tests including, ALT, AST, ALP, and Total Bilirubin in Phase 2 after completion of three month intervention
LIver Health Status
Time frame: [Termination of Phase 3 (Washout period), "1 Month"]
Liver health status will assessed through liver function tests including, ALT, AST, ALP, and Total Bilirubin in Phase 3 which is wash-out time
2 secondary outcomes
Dietary Pattern Analysis
Time frame: [Through studyy compeletion, an avaerage of 9 month]
Dietary Pattern Assessment
Time frame: [Through studyy compeletion, an avaerage of 9 month]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh Sugarcane juice in people with Liver; Disease, Inflammatory, run by Pir Mehr Ali Shah Arid Agriculture University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Health Status (time frame: ["1 Month" at study commencement (Phase 1)]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.