View older revisions Content changed at 2021-06-27, 1400/04/06

Protocol summary

Study aim
Determining the effect of cranberry extract on the response to treatment regimen of fatty liver patients on liver enzymes, ultrasound grade, lipid profile and serum glucose levels
Design
The study was an intervention and participants will receive cranberry extract and placebo as a double-sided blind and data analyzer will also be blind. The sample size will be 80 people who will receive 50% of the sample volume of cranberry extract and 50% placebo for 6 months and then will be analyzed.
Settings and conduct
The study will be performed in the specialized clinic of Imam Reza Hospital in Tabriz. Participants will receive cranberry extract and placebo as a double-sided blind and data analyzer will also be blind.
Participants/Inclusion and exclusion criteria
Entry conditions: Patients with non-alcoholic fatty liver grade 1, 2 and 3 Patients with newly diagnosed fatty liver Candidates for fatty liver treatment No entry conditions: Patient dissatisfaction Rule out the diagnosis of fatty liver
Intervention groups
Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver who will receive one cranberry extract daily for 6 months. Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one plasebo daily for 6 months.
Main outcome variables
Determination of lipid profile level before and after cranberry and placebo use Determination of serum insulin and fasting glucose levels before and after cranberry and placebo Determination of Ultrasound grade before and after cranberry and placebo Determination of serum levels of liver enzymes before and after cranberry and placebo

General information

Reason for update
for increasing generalizability of result all patients with NAFLD (grade 1-3) were included. moreover, some confounding factors that affect the result of the study were considered as exclusion criteria such as alcohol consumption and use of vitamin and antioxidant supplements. we sampled more than anticipated number, 94 patients
Acronym
IRCT registration information
IRCT registration number: IRCT20200725048200N1
Registration date: 2020-08-11, 1399/05/21
Registration timing: registered_while_recruiting

Last update: 2021-06-27, 1400/04/06
Update count: 2
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
Elham Shirinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3389 3038
Email address
elham.shirinpour67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-27, 1399/05/06
Expected recruitment end date
2021-07-28, 1400/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Cranbery in management of non-alcoholic Fatty Liver Patients
Public title
Evaluation of the efficacy of Cranbery in treatment of Fatty Liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-alcoholic fatty liver grade1, 2 and 3 Patients with newly diagnosed fatty liver Candidates for fatty liver treatment
Exclusion criteria:
Patient dissatisfaction Rule out the diagnosis of fatty liver Drug intolerance Existence of diabetes, , heart, renal and pulmonary failure, other liver diseases in which fatty liver appears in the picture alcohol consumption antioxidant and vitamins supplements other that vitamin E pregnant and lactating mothers
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will receive cranberry extract and placebo as a double-sided blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2020-04-20, 1399/02/01
Ethics committee reference number
IR.TBZMED.REC.1399.090

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
Determination of lipid profile level before and after cranberry and placebo use
Timepoint
Study time and 6 months after taking cranberry extract and placebo
Method of measurement
Perform blood tests

2

Description
Determination of serum insulin and fasting glucose levels before and after cranberry and placebo
Timepoint
Study time and 6 months after taking cranberry extract and placebo
Method of measurement
Perform blood tests

3

Description
Determination of Ultrasound grade before and after cranberry and placebo
Timepoint
Study time and 6 months after taking cranberry extract and placebo
Method of measurement
Ultrasound device

4

Description
Determination of serum levels of liver enzymes before and after cranberry and placebo
Timepoint
Study time and 6 months after taking cranberry extract and placebo
Method of measurement
Perform blood tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver.Cranberry extract is called Cranberry Shari, which is the brand name.Ingredients of its formulation 144 mg of cranberry fruit extract (Vaccinium Macrocarporn)،Standardized based on the presence of 25% proanthocyanidin، Equivalent to 36 mg of active ingredient (equivalent to 13 g of dried cranberry fruit).Patients will receive one daily, preferably with food, for 6 months. Possible side effects of the drug include gastrointestinal disorders (nausea and vomiting) and diarrhea (if taken in large amounts) explained to patients in the first session and then in the next sessions the referral will be asked about its possibility.
Category
Treatment - Drugs

2

Description
Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one placebo daily for 6 months. The duration of use, the manner of consumption of patient education and follow-up of patients will be completely according to the patients receiving the main drug.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Elham Shirinpour
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
elham.shirinpour67@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad hossein Somi
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
elham.shirinpour67@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gastrointestinal and Liver Diseases Research Center, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Kourosh Masnadi shirazi nezhad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
kurmas23@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kourosh Masnadi shirazi nezhad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
kurmas23@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elham Shirinpour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golgasht St., in front of the Central University Organization, Imam Reza Educational and Medical Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
elham.shirinpour67@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, patients' identities are not shared.
When the data will become available and for how long
Access period starts 12 months after the results are published.
To whom data/document is available
Data will only be available to researchers in this study.
Under which criteria data/document could be used
The data will be available to researchers only for meta-analysis study and for data analysis.
From where data/document is obtainable
Receipt of data will be done through the scientific respondent of the study.
What processes are involved for a request to access data/document
To receive the data, an email is sent to the scientific respondent and the reason for receiving the data is mentioned in detail and if the reasons are appropriate, the information will be sent.
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