The effect of rosa canina supplement on liver enzymes, lipid profile, fasting blood glucose and anthropometric indices in patients with non-alcoholic fatty liver disease under weight loss diet
Determining the effect of wild rosa canina supplement on liver enzymes, lipid pattern, fasting blood glucose and anthropometric indices in non-alcoholic fatty liver patients under weight loss diet.
Design
Clinical trial with a control group; parallel groups; bilaterally blind; randomization with RAS software; on 100 patients
Settings and conduct
The current study is a clinical trial designed to investigate the effect of wild nester supplement on liver enzyme levels, lipid pattern, fasting blood glucose and body composition in NAFLD patients under a weight loss diet. People who meet the criteria for entering the study and are confirmed by an internal physician with ultrasound after obtaining a written consent will be included in the study by referring to the Shafa specialized clinic in Khalkhal city.
The intervention group will be given a weight loss diet and 1 gram of rosa canina twice a day in the form of a 500 mg capsule with a glass of water in the morning and evening snacks for 8 weeks.
The control group will be given a weight loss diet and 1 gram of placebo twice a day in the form of a 500 mg capsule with a glass of water in the morning and evening meals for 8 weeks; It should be noted that this placebo will look exactly the same as the rosa canina capsule.
The effect of rosa canina supplement on liver enzymes, lipid profile, fasting blood glucose and anthropometric indices in patients with non-alcoholic fatty liver disease under weight loss diet
Public title
Effect of rosa canina on non alcoholic fatty liver disaese
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people with non-alcoholic fatty liver disease referring to Internist
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling by randomization method with RAS software and allocation of 3-digit codes with sealed envelopes will be done by a person outside the study, then people will be allocated to two groups by block randomization based on age.
Blinding (investigator's opinion)
Double blinded
Blinding description
The principal investigator of this study and the study participants are kept blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Khalkhal university of medical science
Street address
Khalkhal university of medical science, Mozaffar Azizi st , imam blv
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Approval date
2023-08-05, 1402/05/14
Ethics committee reference number
IR.KHALUMS.REC.1402.007
Health conditions studied
1
Description of health condition studied
Non alchoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Liver enzymes
Timepoint
At the beginning of the study and 8 weeks after the start of taking rosa canina supplement
Method of measurement
Pars azmoon liver enzymes kit
2
Description
Lipid profile
Timepoint
At the beginning of the study and 8 weeks after the start of taking rosa canina supplement
Method of measurement
Pars Azmoun Cholesterol Quantification Kit
3
Description
fasting blood sugar
Timepoint
At the beginning of the study and 8 weeks after the start of taking rosa canina supplement
Method of measurement
Glucose Quantification Kit Pars Azman
4
Description
Body weight
Timepoint
At the beginning of the study and 8 weeks after the start of taking rosa canina supplement
Method of measurement
Seca scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
At the beginning of the study and 8 weeks after the start of taking rosa canina supplement
Method of measurement
Barometer
2
Description
Waist circulate
Timepoint
At the beginning of the study and 8 weeks after the start of taking rosa canina supplement
Method of measurement
Measuring tape
3
Description
Body fat mass
Timepoint
At the beginning of the study and 8 weeks after the start of taking rosa canina supplement
Method of measurement
Inbody body analyzer
4
Description
Body muscle mass
Timepoint
At the beginning of the study and 8 weeks after the start of taking rosa canina supplement
Method of measurement
Inbody body analyzer
Intervention groups
1
Description
Intervention group: The intervention group will be given a weight loss diet and 1 gram of rosa canina 2 times a day in the form of 500 mg capsules with a glass of water in the morning and evening snacks for 8 weeks. It was disinfected and packaged in Ardabil University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: The control group will be given a weight loss diet and 1 gram of placebo twice a day in the form of a 500 mg capsule with a glass of water in the morning and evening meals for 8 weeks; It should be noted that this placebo will look exactly the same as the rosa canina capsule. Starch powder will be used for placebo capsules. Placebo capsules will be prepared by the Faculty of Pharmacy of Ardabil University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa clinic
Full name of responsible person
Vahideh Aghamohammadi Khiavi
Street address
Shafa clinic, Mozaffar Azizi st, Imam blv
City
khalkhal
Province
Ardabil
Postal code
5681856118
Phone
+98 45 3243 2002
Email
v.aghamohammadi@khalums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khalkhal university of medical science
Full name of responsible person
hamed rezakhani moghadam
Street address
khalkhal university of medical science , Mozaffar azizi st , Imam blv
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3242 6801
Email
h.rezakhani@khalums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khalkhal university of medical science
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
Khalkhal university of medical science
Full name of responsible person
Vahideh Aghamohammadi khiavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Khalkhal university of medical science , Mozaffar Azizi st , Imam blv
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
32426801
Email
v_agamohammadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khalkhal university of medical science
Full name of responsible person
Vahideh Aghamohammadi khiavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Khalkhal university of medical science , Mozaffar Azizi st , Imam blv
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3243 2002
Fax
Email
v_agamohammadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Khalkhal university of medical science
Full name of responsible person
Vahideh Aghamohammadi khiavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Khalkhal university of medical science , Mozaffar Azizi st , Imam blv
City
Khalkhal
Province
Ardabil
Postal code
۵۶۸۱۷۶۱۳۵۱
Phone
+98 45 3243 2002
Fax
Email
v_agamohammadi@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
Not applicable
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