Determining the effect of Rivandi syrup in patients with non-alcoholic fatty liver referred to the clinics of the Medical University of Tehran in 2023
1- Determining and comparing the level of Aspartate transferase (AST) before and after
2- Comparing the level of alanine aminotransferase (ALT)
3 - Comparing the level of controlled attenuation parameter (CAP) fibroscan
4 - Determining and comparing the level of fibrosis liver stiffness measurement(LSM) index
5- Comparing body mass index
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase two on 50 patients.
A number of 50 patients were selected based on the inclusion criteria and after performing a fibroscan and fatty liver confirmation. After randomly coding all 4 patients (blocks of 4) according to the time of entering the RCT (randomization with RANDBetween function of Excel software) from A to D. Examined by a specialist and receive the drug or placebo according to its label and are examined. One group is prescribed Rivandi syrup (25 people) and the second group (25 people) is prescribed placebo.
Settings and conduct
Patients with non-alcoholic fatty liver disease who refer to the affiliated clinics of Tehran University of Medical Sciences will be evaluated
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People aged 20-60 years with non-alcoholic fatty liver according to the approval of the fibroscan device
Exclusion criteria:
Diagnosis of acute diseases that have a bad effect on liver function, such as gallstones and surgery
History of alcohol consumption and alcoholic beverages
Pregnancy or breastfeeding
Patients with hypokalemia
Intervention groups
Case Patients: Prescribe Rivandi Syrup for 3 months
Control Patients: Prescribe placebo syrupe for 3 months
At first, a block of 4 (A-B-C-D) is created, and bottles of drugs or placebos have one of these four labels. In it, there are two letters of drug and two letters of placebo (for example, A and D for drug and B and C for placebo).
According to the order of the patients' referral to the plan and after obtaining written consent, the patient will be placed in one of the 4 groups randomly (lottery), and after 4 patients enter the RCT and the end of the 4-pack, another 4-pack will be opened for the 5th to 8th patients. can be Medicines labeled A to D are delivered to Salamat Kedeh pharmacy and the patient receives the medicine with that label after drawing a lottery and getting the letter A, B, C, or D.
Blinding (investigator's opinion)
Double blinded
Blinding description
Bottles of drugs with labels A to D are made by the pharmacist and delivered to the Salamat Kode pharmacy, which two labels are drug and two are placebos, and the pharmacist only knows the contents of each bottle. Patients receives that label and until the end of the RCT (3 Months), it is delivered to him with all the initial labels
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences (TUMS)
Street address
6th Floor- Central building of TUMS- Qods St- Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-05-23, 1401/03/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.167
Health conditions studied
1
Description of health condition studied
Non Alcoholic Fatty Liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
CAP (Controlled Attenuation Parameter) Index in Fibroscan
Timepoint
0 and 3 Months
Method of measurement
Fibroscan Device
2
Description
LSM (Liver Stiffness Measurement) in Fibroscan
Timepoint
0 and 3 Months
Method of measurement
Fibroscan Device
Secondary outcomes
1
Description
Blood Serum Aspartate Transferase (AST)
Timepoint
0 and 3th months
Method of measurement
Blood Test
2
Description
Blood Test Alanine aminotransferase (ALT)
Timepoint
0 and 3th months
Method of measurement
Laboratory Blood Test
3
Description
Blood Test Alkaline phosphatase (ALP)
Timepoint
0 and 3th months
Method of measurement
Laboratory Blood Test
4
Description
Body Mass Index (BMI)= ratio of person's weight in kilograms and height in metres squared
Timepoint
0 and 3th months
Method of measurement
Standard Scale
Intervention groups
1
Description
Intervention group: rhubarb syrup is prepared in the pharmacy laboratory of the Faculty of Traditional Medicine of Tehran University of Medical Sciences (Jalinian medicine) with the combination of Chinese rhubarb, Fumitory and Dodder, whose herbarium code is obtained from the Faculty of Pharmacy of the university, and in 250 bottles CC is provided to patients. Consuming it as one tablespoon three times a day (breakfast, before lunch and before bed)
Category
Treatment - Drugs
2
Description
Control group: Placebo syrup is prepared in the pharmaceutical laboratory of the Faculty of Traditional Medicine of Tehran University of Medical Sciences and is available to patients in 250 cc bottles. Consuming it as one tablespoon three times a day (before breakfast, before lunch and before bed)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of medical science (Ahmadieh Clinic)
Full name of responsible person
Hamid Ghaderi
Street address
North Sarparast St- Felestin Sq
City
Tehran
Province
Tehran
Postal code
2188974535
Phone
+98 21 8897 4535
Email
spm@tums.ac.ir
Web page address
https://spm.tums.ac.ir/contact-us.html
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mehrdad Karimi
Street address
No27- North Sarparast-Felestin Sqr
City
Tehran
Province
Tehran
Postal code
2188974535
Phone
+98 21 8897 4535
Email
spm@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Rezaeizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No27- North Sarparast St- Felestin Sq
City
Tehran
Province
Tehran
Postal code
2188974535
Phone
+98 21 8897 4535
Email
rezaeizadeh@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Rezaeizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No27- North Sarparast- Felestin Sq
City
Tehran
Province
Tehran
Postal code
2188974535
Phone
+98 21 8897 4535
Email
rezaeizadeh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Shahbazi
Position
PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No 6- East &th st- Farhang Sq- Saadatabad
City
Tehran
Province
Tehran
Postal code
1997756967
Phone
+98 21 2208 4078
Email
drshahbazi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available