Protocol summary
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Study aim
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Determining the effect of quine oxymel consumption on the indicators of non-alcoholic fatty liver
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Design
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Clinical trial with a control group, with parallel groups, three blinded, randomized, phase 2 on 80 patients. Randomization by block randomization method
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Settings and conduct
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The project will be performed in Gastroenterology Specialist Clinic, Doctors City, Qom City of Qom University. After obtaining written informed consent, people who meet the criteria for entering the study will receive the drug or placebo with the same packaging and similar in terms of appearance, color, and scent randomly.
A special code label is installed on the syrup by the pharmaceutical consultant. The drug will be provided to the doctor and plan executive and the patient. The code of each syrup, specific to each patient, will be inserted in the patient's file and checklist by the administrator. And at the end of the study, for statistical analysis, the information and checklist form of the patients will be provided to the statistics consultant
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age 20 to 65
Fatty liver grade two and above
Liver enzymes are higher than normal level
Exclusion criteria :
Diabetes, viral hepatitis, and autoimmune and metabolic causes
History of alcohol consumption
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Intervention groups
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Eighty fatty liver patients will be randomly divided into intervention and control groups. The intervention group will be treated with ten milliliters of saffron syrup and quine oxymel three times a day, half an hour before meals, and the control group will be treated with placebo syrup in the same way.
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Main outcome variables
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Grade of non-alcoholic fatty liver in sonography report
General information
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Reason for update
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Changing the study start and end datesو Modifying the study site
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221202056689N1
Registration date:
2023-01-25, 1401/11/05
Registration timing:
prospective
Last update:
2026-06-03, 1405/03/13
Update count:
2
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Registration date
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2023-01-25, 1401/11/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-07-06, 1402/04/15
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Expected recruitment end date
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2024-10-01, 1403/07/10
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Actual recruitment start date
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2023-07-06, 1402/04/15
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Actual recruitment end date
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2024-10-01, 1403/07/10
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Trial completion date
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2024-10-01, 1403/07/10
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Scientific title
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Investigating the therapiotic effect of quince oxymel on treatment of non-alcoholic fatty liver disease - Randomized clinical Trial, triple Blinded, placebo controlled
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Public title
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Investigating the effect of quince oxymel on non-alcoholic fatty liver
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients between the ages of 20 and 65 years
are diagnosed with grade 2 or higher fatty liver based on the ultrasound report
liver enzymes that are higher than the normal level.
Exclusion criteria:
Having diabetes
Viral hepatitis and autoimmune hepatitis
Having metabolic diseases such as Wilson's disease and hemochromatosis
History of alcohol consumption and alcoholic beverages
Liver transplant at some point in the past
Taking any type of medicine to treat fatty liver in the past one month
The patient's unwillingness to continue the plan
Severe allergy or drug complication
Pregnancy and breastfeeding
Taking Varfarin, heparin compounds and anticoagulant drugs
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Age
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From 20 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
80
Actual sample size reached:
73
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization of patients will be by block randomization method. For this purpose, the volume of each block is four people, and the number of blocks required for the study is equal to 20 four-person blocks.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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A special code will be considered for each syrup and this code will be recorded on the syrup label. Only the pharmacist consultant will know about the drug codes. Medicines will be provided to the doctor and plan administrator and the patient. The code of each syrup, specific to each patient, will be inserted in the patient's file and checklist by the administrator. At the end of the study, the information and checklist form of the patients will be provided to the statistics consultant for statistical analysis, and after the data analysis, the code of the syrups will be provided to the administrator and the statistics consultant for the final analysis. syrups in intervention and comparison groups are similar according to color, smell, shape and route of use.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-21, 1401/08/30
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Ethics committee reference number
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ir.muq.rec.1401.176
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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Non-alcoholic fatty liver grade
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Timepoint
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At the beginning of the study (before the start of the intervention) and twelve weeks after the intervention
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Method of measurement
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ultrasound device
2
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Description
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Alanine aminotransferase enzyme
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Timepoint
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در ابتدای مطالعه ( قبل از شروع مداخله ) و دوازده هفته بعد از مداخله
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Method of measurement
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Measuring the serum level of alanine aminotransferase enzyme in peripheral blood samples
3
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Description
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Aspartate aminotransferase
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Timepoint
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در ابتدای مطالعه ( قبل از شروع مداخله ) و دوازده هفته بعد از مداخله
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Method of measurement
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اندازه گیری سطح سرمی آنزیم آسپارتات آمینو ترانسفراز در نمونه خون محیطی
Intervention groups
1
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Description
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Intervention groupPatients with fatty liver referred to the Gastroenterology Specialist Clinic, Doctors City, Qom City are selected according to the entry criteria and randomly divided into intervention and control groups. The patients of the intervention group are treated with ten milliliters of quine oxymel syrup three times a day, half an hour before meals, for twelve weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients with fatty liver referred to the gastroenterology clinic of Gastroenterology Specialist Clinic, Doctors City, Qom City are selected according to the entry criteria and randomly divided into intervention and control groups. Control group patients are treated with ten milliliters of placebo three times a day, half an hour before meals for twelve weeks. The placebo is made in the laboratory of Iranian Medicine Faculty of Qom University
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ghoum University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The data related to the outcome of the study include the changes in the grade of fatty liver in the sonography report and the changes in liver enzymes that can be shared.
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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Researchers of academic and scientific institutions
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Under which criteria data/document could be used
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Use in the treatment of patients and use in scientific articles
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From where data/document is obtainable
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Dr. Fatemeh Ali Asl, Assistant Professor, Faculty of Traditional Medicine, Qom University. . Mehrdad Ababaf Shushtri, Ph.D. Specialist Assistant, Faculty of Traditional Medicine, University of Qom.
. mehrdadababaf@yahoo,com/.Aliasl1392@gmail.com
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What processes are involved for a request to access data/document
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Send a request by email and receive a response within two working weeks
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Comments
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This study is the first clinical trial to investigate the effect of lemon jelly in the treatment of non-alcoholic fatty liver disease.