The effect of traditional medicine capsule based on purslane and chicory on oxidative stress Indicators and Lipid Profile in patients with fatty liver disorder
The aim of this study was to evaluate the effect of hepatobel capsule on fatty liver recovery by measuring lipid profile and oxidative stress indices.
Design
In this study, 60 patients with fatty liver are divided into two groups of drug and placebo (n= 30 in each group). Grouping is simple and random. This is a double-blind study.In this study, blood samples are taken from individuals before the intervention and after 6 weeks of taking the capsules. Then, lipid profiles and oxidative stress indicators in these individuals are examined
Settings and conduct
If the individuals agree to participate in the research, written consent will be obtained from them and their information will be recorded in the relevant questionnaire. After 12 hours of fasting blood sampling are taken from the patient.Biochemical tests related to liver parameters are measured. Then, patients with liver function disorders are randomly divided into two groups. One group is receiving hepatobel capsules and the other receiving the placebo. This is a double-blind study in which participants and statistical analyst do not know the groups. After completing the 6-week intervention, blood sampling was performed again and the biochemical factors were evaluated to evaluate the effect of hepatobel capsules.
Participants/Inclusion and exclusion criteria
Patients with hepatic impairment indicators are enrolled in the study. These patients should not have heart and kidney disease. If a participant becomes allergic to the capsule during the study or can not continue reading, exit from the study.
Intervention groups
The group receiving the drug: This group consume three capsules daily for 6 weeks . The group receiving the placebo: This group consume three capsules daily for 6 weeks .
Main outcome variables
Improved fatty liver
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141027019705N3
Registration date:2020-09-21, 1399/06/31
Registration timing:registered_while_recruiting
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Mehdi Salehi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 8165
Email address
m_salehi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-09, 1399/06/19
Expected recruitment end date
2020-11-09, 1399/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of traditional medicine capsule based on purslane and chicory on oxidative stress Indicators and Lipid Profile in patients with fatty liver disorder
Public title
The effect of hepatobel capsules in the treatment of fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not having known heart disease
Not having known kidney disease
Having abnormal liver parameters
Having aged 20 to 60 years.
Exclusion criteria:
Unwilling to continue study
Find sensitivity to hepatobel capsules
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To assign individuals to two groups of drugs and placebo block randomization method,using Random allocation software, with 4, 6 and 8 block sizes will be used, which by using this method, concealment will also be observed. In this method, each person is assigned a unique code and pasted on the drug packages, which will also help the blinding process.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, it will be explained about the study to the participants.
This study is a double blind study.
The two groups of drug and placebo receive very similar capsules, and they do not know the contents of the capsule
The statistical analyzer is not informed about the groups..
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Iran, Arak, Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.ARAKMU.REC.1398.316
Health conditions studied
1
Description of health condition studied
Patients with fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Improving liver function
Timepoint
Measurement of lipid profile and oxidative stress indices in the beginning of the study (before the start of the study) and 6 weeks after the intervention
Method of measurement
Measuring lipid profile and oxidative stress indices using biochemical kits.
Secondary outcomes
1
Description
Improving lipid profile
Timepoint
Measurement of lipid profile in the beginning of the study (before the start of the study) and 6 weeks after the intervention
Method of measurement
Measuring lipid profile using biochemical kits.
2
Description
Improving oxidative stress indices
Timepoint
Measurement of oxidative stress in the beginning of the study (before the start of the study) and 6 weeks after the intervention
Method of measurement
Measuring oxidative stress using biochemical kits.
Intervention groups
1
Description
Intervention group: The number of participants in this group is 30 subjects. The group will receive 3 capsules of traditional medicine based on portulaca oleracea and Cichorium intybus (500 mg) daily for 6 weeks. This capsule is made by Sanabel Drug Company.
Category
Treatment - Drugs
2
Description
Control group: This group received 3 placebo capsules (500 mg) daily for 6 weeks. This capsule is made by Sanabel Drug Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Clinic
Full name of responsible person
Mehdi Salehi
Street address
Imam Street, Kowsar Clinic
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
m_salehi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
m_salehi@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
m_salehi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sardasht, Basij Square, near Amiral-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Email
m_salehi@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Information from people participating in a study based on ethics should remain confidential.