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Formulation and evaluation of the effectiveness of "Berberpim®" syrup in patients with Non-alcoholic fatty liver disease: A randomized clinical trial study

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History
# Registration date Revision Id
2 2021-10-31, 1400/08/09 203665
1 2021-09-02, 1400/06/11 196178
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  • Protocol summary

    This study was performed randomly on 46 patients including intervention and control groups in Bustan Clinic of Kermanshah University of Medical Sciences. In this way, 10 cc of syrup is used twice daily. Blinding is performed for patients, clinical caregivers and outcome assessors. Randomization is also done using blocks of 4 and 6.
    This study was performed randomly on 46 patients including intervention and control groups in Ejlalieh Clinic of Kermanshah University of Medical Sciences. In this way, 10 cc of syrup is used twice daily. Blinding is performed for patients, clinical caregivers and outcome assessors. Randomization is also done using blocks of 4 and 6.
    این مطالعه در کلینیک بوستان دانشگاه علوم پزشکی کرمانشاه به صورت تصادفی روی 46 بیمار شامل گروه مداخله و کنترل انجام می گردد. بدین صورت که روزی دو بار 10 سی سی از شربت استفاده می شود. کور سازی برای بیماران، مراقب بالینی و ارزیابی کننده پیامد انجام می شود. تصادفی سازی نیز با استفاده از بلوکهای 4 و 6 تایی صورت می پذیرد.
    این مطالعه در کلینیک اجلالیه دانشگاه علوم پزشکی کرمانشاه به صورت تصادفی روی 46 بیمار شامل گروه مداخله و کنترل انجام می گردد. بدین صورت که روزی دو بار 10 سی سی از شربت استفاده می شود. کور سازی برای بیماران، مراقب بالینی و ارزیابی کننده پیامد انجام می شود. تصادفی سازی نیز با استفاده از بلوکهای 4 و 6 تایی صورت می پذیرد.

  • General information

    empty
    Due to the need to determine the grade of the disease as one of the criteria for inclusion in the study and change of the disease center, the mentioned cases were corrected.
    empty
    با توجه به لزوم تعیین گرید بیماری به عنوان یکی از معیارهای ورود به مطالعه و تغییر مرکز بیمارگیری، موارد ذکر شده اصلاح گردید.
    Age over 18 years
    Patients with Non-alcoholic fatty liver disease according to the results of ultrasound, clinical interview, increase in liver enzymes and elimination of other causes this disease affects Non-alcoholic fatty liver
    Age over 18 years
    Patients with grade I and II Non-alcoholic fatty liver disease according to the results of ultrasound, clinical interview, increase in liver enzymes and elimination of other causes this disease affects Non-alcoholic fatty liver
    سن بالای 18 سال
    بیمارانی که طبق نتایج حاصل از سونوگرافی، مصاحبه کلینیکی، افزایش آنزیم های کبدی و رد سایر علل این بیماری به کبد چرب غیر الکلی مبتلا هستند
    سن بالای 18 سال
    بیمارانی که طبق نتایج حاصل از سونوگرافی، مصاحبه کلینیکی، افزایش آنزیم های کبدی و رد سایر علل این بیماری به کبد چرب غیر الکلی گرید I و II مبتلا هستند

  • Ethics committees

    #1
    2021-08-25, 1400/06/03
    2021-10-19, 1400/07/27
    261.IR.KUMS.REC.1400
    IR.KUMS.REC.1400.543

  • Recruitment centers

    #1
    Name of recruitment center - English: Bustan Clinic of Kermanshah
    Name of recruitment center - Persian: کلینیک بوستان کرمانشاه
    Full name of responsible person - English: DR. Mohammad Hossein Farzaei
    Full name of responsible person - Persian: دکتر محمد حسین فرزایی
    Street address - English: Kermanshah, Parastar Blvd., in front of the Medical School, Bustan Clinic
    Street address - Persian: کرمانشاه، بلوار پرستار، روبروی دانشکده پزشکی، کلینیک بوستان
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6715847141
    Phone: +98 83 3427 6300
    Fax:
    Email: mh-farzaee@razi.tums.ac.ir
    Web page address:
    Name of recruitment center - English: Ejlalieh Clinic of Kermanshah
    Name of recruitment center - Persian: کلینیک اجلالیه کرمانشاه
    Full name of responsible person - English: DR. Mohammad Hossein Farzaei
    Full name of responsible person - Persian: دکتر محمد حسین فرزایی
    Street address - English: Kermanshah, West Moallem Street, Parking Shahrdari
    Street address - Persian: کرمانشاه، خیابان معلم غربی، پارکینگ شهرداری
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6714694451
    Phone: +98 83 3728 4242
    Fax:
    Email: mh-farzaee@razi.tums.ac.ir
    Web page address:

Protocol summary

Study aim
The aim of this study was to prescribe "Berberpim®" syrup to patients with Non-alcoholic fatty liver disease and evaluate its effectiveness in a randomized, double-blind, placebo-controlled clinical trial.
Design
In this study, 46 patients were randomly assigned to take "Berberpim®" syrup (intervention) or placebo (control) for 3 months. In this way, 10 cc of syrup is used twice daily.
Settings and conduct
This study was performed randomly on 46 patients including intervention and control groups in Ejlalieh Clinic of Kermanshah University of Medical Sciences. In this way, 10 cc of syrup is used twice daily. Blinding is performed for patients, clinical caregivers and outcome assessors. Randomization is also done using blocks of 4 and 6.
Participants/Inclusion and exclusion criteria
The main inclusion criteria are the following: age over 18 years; patients to sign a written consent and have the necessary cooperation during the study and patients who have the disease according to the results of ultrasound, clinical interview, increase in liver enzymes. Main exclusion criteria also include: patients with Hepatitis; Wilson's disease; people who drink alcohol; people with type I diabetes and type II diabetes who have been taking drugs for a year and people taking drugs that affect the level of liver enzymes such as Statins and Acetaminophen in high doses.
Intervention groups
Intervention: Twice daily oral administration of 10 cc of "Berberpim®" syrup for 3 months Control: Twice daily oral administration of 10 cc of placebo syrup for 3 months
Main outcome variables
Biochemical factors (serum levels of CRP; ESR; LDL; HDL; ALT; AST; triglycerides; cholesterol; platelets; vitamin D; fasting blood sugar) and anthropometric factors (BMI; weight and abdominal circumference)

General information

Reason for update
Due to the need to determine the grade of the disease as one of the criteria for inclusion in the study and change of the disease center, the mentioned cases were corrected.
Acronym
IRCT registration information
IRCT registration number: IRCT20210814052178N1
Registration date: 2021-09-02, 1400/06/11
Registration timing: prospective

Last update: 2021-11-01, 1400/08/10
Update count: 1
Registration date
2021-09-02, 1400/06/11
Registrant information
Name
Kiana Anboohgol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3720 0622
Email address
kanboohgol@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and evaluation of the effectiveness of "Berberpim®" syrup in patients with Non-alcoholic fatty liver disease: A randomized clinical trial study
Public title
The effect of "Berberpim®" syrup on Non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Patients with grade I and II Non-alcoholic fatty liver disease according to the results of ultrasound, clinical interview, increase in liver enzymes and elimination of other causes this disease affects Non-alcoholic fatty liver
Exclusion criteria:
Patients with Hepatitis Wilson's disease People who drink alcohol People with type I diabetes and type II diabetes who have been taking the drug for a year Consumers of drugs that affect the level of liver enzymes such as Statins and Acetaminophen in high doses
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, two groups that meet the inclusion criteria are randomly assigned to the drug and placebo groups. Randomization process is done using 4 and 6 blocks. Blocking will be done by online randomization software www.sealedenvelope.com
Blinding (investigator's opinion)
Double blinded
Blinding description
The double-blind method is used for blinding. The list of intervention groups identified in this process remains with the coordinator. The person responsible for evaluating the entry / exit criteria and registration of individuals will not be aware of this process. None of the patients and the evaluator will know the type of treatment
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
School of Pharmacy, Kermanshah University of Medical Sciences, Daneshgah St., Shahid Shiroodi Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-10-19, 1400/07/27
Ethics committee reference number
IR.KUMS.REC.1400.543

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Alanine transaminase
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

2

Description
Aspartate transaminase
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

3

Description
Triglyceride
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

4

Description
Cholesterol
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

5

Description
High-density lipoprotein
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

6

Description
Low-density lipoprotein
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

7

Description
Fasting blood sugar
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

8

Description
Platelets
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

9

Description
Vitamin D
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

10

Description
C-Reactive Protein
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

11

Description
Erythrocyte Sedimentation Rate
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Blood Test

12

Description
Weight
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Weighing scales

13

Description
Abdominal circumference
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Tapeline

14

Description
Body mass index
Timepoint
Before intervention, 3 months after intervention
Method of measurement
Special formula

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Twice daily use 10 cc of Berberpim syrup to move for 3 months
Category
Treatment - Drugs

2

Description
Control group: Twice daily use of 10 cc placebo for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ejlalieh Clinic of Kermanshah
Full name of responsible person
DR. Mohammad Hossein Farzaei
Street address
Kermanshah, West Moallem Street, Parking Shahrdari
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 83 3728 4242
Email
mh-farzaee@razi.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Farzaei
Street address
Kermanshah, Shahid Shiroodi Blvd., Daneshgah St., Faculty of Pharmacy, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6743667149
Phone
+98 83 3428 1374
Email
mh-farzaee@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
Kiana Anboohgol
Position
دانشجوی دکترای حرفه ای داروسازی
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Kermanshah, Shahid Shiroodi Blvd., Daneshgah St., Faculty of Pharmacy, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 35 24402
Email
Kanboohgol@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Farzaei
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Kermanshah, Shahid Shiroodi Blvd., Daneshgah St., Faculty of Pharmacy, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 35 24402
Email
mh-farzaee@razi.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Kiana Anboohgol
Position
Professional doctorate student in Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Kermanshah, Shahid Shiroodi Blvd., Daneshgah St., Faculty of Pharmacy, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714694451
Phone
+98 35 24402
Email
Kanboohgol@yahoo.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
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