The prevalence of fatty liver is estimated about 5.21 - 5.31% in Iran. High prevalence and chronic nature of this disease affects the quality of life of the people and imposes a serious economic burden on society, the effectiveness and safety of pharmacological treatment of NAFLD remains unknown so far. The aim of this study is that the rosehip regarding to its opposite effect to insulin resistance and lipid-lowering serum can control fatty liver. In this double-blind clinical trial, people with fatty liver who referred to this clinic will be invited to participate in the study. Patients were then randomly (random allocation) will be divided into two groups taking supplement and taking placebo. Each patient will receive two can of rosehip capsule or placebo for consume during four weeks. Each supplement capsule contains one gram rosehip and each placebo contains the same amount of corn flour. Duration of supplement intake in this study based on similar studies is considered 16 weeks
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410265968N5
Registration date:2017-10-15, 1396/07/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Hadis Sabour
Name of organization / entity
Brain and Spinal Injury Research Center (BASIR)
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1560
Email address
hsabour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Brain and Spinal Injury Research Center (BASIR), Tehran University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of rosehip supplement consumption on fatty liver grade and liver enzymes in comparison with control group in patients with fatty liver
Public title
The effect of rosehip supplement consumption on fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.Age between 18 and 70 years 2.Fatty liver disease. Exclusion criteria: 1. Alcohol consumption 2.Smoking 3.taking certain medication, such as blood pressure medications, Insulin sensitivity enhancers, statins, hepatotoxic drugs such as Phenytoin, tamoxifen, lithium and supplements 4. Acute liver disorders such as Hepatitis B and C, liver transplantation, biliary disease known as autoimmune disease, cancer, inherited disorders affecting liver condition (iron and copper storage disease) and other disease 5.Failure to sign the ethical consent.
Age
From 17 years old to 69 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
This is a double-blind study; so that not only control and target groups but also the researchers are not aware of the medications. To do this we use a randomization table given by a statistics consult.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tehran University of Medical Sciences.
Intervention group will receive two cans of rosehip supplement for four weeks consume. The amount of consumption of supplement will be 5 gram daily. Each supplement contains 1 gram of rosehip flour. Patients will be advised to take two capsules with breakfast, two with lunch, and one with dinner.
Category
Treatment - Drugs
2
Description
Control group will receive two cans of placebo for four weeks consume. The amount of consumption of placebo will be 5 gram daily. Each placebo contains 1 gram of corn flour. Patients will be advised to take two capsules with breakfast, two with lunch, and one with dinner