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Investigation of the Efficacy of Carom copticum on Fatty Liver Grade in Patients with Non-Alcoholic Fatty Liver

Protocol summary

Study aim
determine the effect of C.copticum on the improvement of fatty liver in patients with non-alcoholic fatty liver.
Design
In this research, 72 eligible patients with non-alcoholic Fatty liver referring to the gastroenterology clinic of Baghiyatallah Hospital were chosen purposefully and were randomly divided into two groups of control and intervention. Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
This is a double-blind clinical trial that was performed at gastroenterology clinic of Baghiyatallah Hospital in Tehran. The subjects of the study and the study monitoring committee blindness.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Non-Alcoholic fatty liver diagnosis of grades 1 to 3 based on sonography, age 18-60 years, person's willingness to participate in the study. Exit criteria: The patient's unwillingness to participate in the program; Hepatitis (cirrhosis, alcoholic liver disease, viral hepatitis and autoimmunity, cirrhosis, hereditary hemochromatosis, sclerosis, cholangitis, etc.); other serious illnesses (cancer, kidney failure Celiac and ...); pregnancy; lactation; use of drugs that affect liver tests over the past 2 months (statins, glitazones, chlorpropamizine, anabolic steroids, tionamides, vit.E, OCP, etc.); alcohol consumption. Also, if the liver enzymes increase during the course of the design and the need for treatment according to the expert opinion of the digestive tract, the patient will be excluded from the project.
Intervention groups
In this study, patients with fatty liver were randomly divided into two groups of 36 patients. The first group of carom copticum and the control group are given placebo. The drug and placebo are in capsules of 250 mg and twice a day after a meal with warm water for 8 weeks.
Main outcome variables
The study's outcomes include improving the degree of fatty liver in patients based on ultrasound, improving digestion of the stomach, and reducing liver enzymes.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171102037178N2
Registration date: 2018-03-11, 1396/12/20
Registration timing: registered_while_recruiting

Last update: 2018-03-11, 1396/12/20
Update count: 0
Registration date
2018-03-11, 1396/12/20
Registrant information
Name
Rasoul Shafiezadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3436 9595
Email address
r.shafiezadeh@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Efficacy of Carom copticum on Fatty Liver Grade in Patients with Non-Alcoholic Fatty Liver
Public title
effect of C.copticum on non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of non-alcoholic fatty liver with grade 1 to 3 according to liver ultrasound The patient's willingness to participate in the plan Age of 18 to 60 years
Exclusion criteria:
Unwillingness to participate in the plan Disease of the liver Like: Hepatitis, Hemochromatosis, Cirrhosis Use of effective drugs on liver tests over the past 2 months People with heart failure or kidney disease or diabetes alcohol consumption Pregnancy or breastfeeding
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in this project fall into two groups of intervention and control by simple accident method. Individuals are divided into two intervention and control groups according to random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind clinical trial in which study subjects and the study monitoring committee study blindness.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committees of Shahed University
Street address
Opposite of Imam Khomeiny shrine, Tehran-Qom Freeway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2018-01-08, 1396/10/18
Ethics committee reference number
IR.Shahed.REC.1396.82

Health conditions studied

1

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

2

Description of health condition studied
Functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia

Primary outcomes

1

Description
grade of fatty liver in ultrasound
Timepoint
Evaluating the degree of fatty liver at the beginning of the study and three months after treatment
Method of measurement
Ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group:" The prescribing of the food capsule containing the fruit juice of Carum Copticum , on the basis of 4 grams of fruit , 3 times a day for eight consecutive weeks.
Category
Treatment - Drugs

2

Description
Control group: placebo plus routine care
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiatallah hospital؛ Gastroenterology clinic؛ Tehran
Full name of responsible person
Rasoul shafiezadeh
Street address
Baqiyatallah Hospital; Sheikh Bahaei Intersection; Mulla Sadra Street; Vank Square; Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
r.shafiezadeh@shahed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra kiasalary
Street address
Shahed University, Aftab City, Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
​کد پستی: 33191​1865
Phone
+98 21 5522 8800
Fax
Email
publicrelation@shahed.ac.ir
Web page address
http://iwmf.ir/website/shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Rasoul shafiezadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Iranian medicine group, School of Medicine, Shahed University, Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
dr.r_shafie47@yahoo.com
Web page address
http://iwmf.ir/website/shahed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Rasoul Shafiezadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Aftab city، Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
33191​18651
Phone
+98 31 3436 9595
Fax
Email
r.shafiezadeh@shahed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Rasoul Shafiezadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Iranian medicine group, School of Medicine, Shahed University, Aftab City, Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
33191​18651
Phone
+98 31 3436 9595
Fax
Email
r.shafiezadeh@shahed.ac.ir

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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