1. Determine the effects of L Carnitine on Child score in cirrhotic patients
2. Determine the effects of L Carnitine on MELD score in cirrhotic patients
3. Determine the effects of L Carnitine on abdominal symptoms in cirrhotic patients
4. Determine the effects of L Carnitine on fatigue in cirrhotic patients
5. Determine the effects of L Carnitine on systemic symptoms in cirrhotic patients
6. Determine the effects of L Carnitine on activity in cirrhotic patients
7. Determine the effects of L Carnitine on emotional function in cirrhotic patients
8. Determine the effects of L Carnitine on worry in cirrhotic patients
9. Determine the effects of L Carnitine on sarcopenia in cirrhotic patients
Design
120 cirrhotic patients who referred to liver clinic of Taleghani hospital will be enroll in this study. Our study is triple blind and simple randomized in pahse 3 of clinical trial.1000 mg and 2000 mg daily L-carnitine will be orally administered for 24 weeks in two separate interventional groups and placebo will be used in control group.
Settings and conduct
Study will be done in liver clinic of Taleghani hospital.Demographic data, Lab tests, ascites, encephalopathy, MELD and Child scores, sarcopenia and quality of life will be evaluated at the beginning, 3 months later and six months later. Random assigning will be done by one of our research team and patients, medical doctor and statistician are blind in this study.
Participants/Inclusion and exclusion criteria
Cirrhotic patients who referred to liver clinic of Taleghani hospital with age 18-70 years old and known cause of cirrhosis with child score A or B
Intervention groups
1000 mg daily orally L carnitine
2000 mg daily orally L carnitine
Main outcome variables
Lab tests, ascites, encephalopathy, MELD and Child scores, sarcopenia (gripe strength and muscle mass), quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180313039075N1
Registration date:2021-01-03, 1399/10/14
Registration timing:registered_while_recruiting
Last update:2021-01-03, 1399/10/14
Update count:0
Registration date
2021-01-03, 1399/10/14
Registrant information
Name
Leila Pasharavesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 2304
Email address
leila_lp@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of L Carnitine on quality of life of the cirrhotic patients
Public title
Evaluation the effects of L Carnitine on quality of life of the cirrhotic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Cirrhotic patients who referred to Liver clinic of Taleghani hospital with age 18-70 years old
Cirrhotic patients who referred to Liver clinic of Taleghani hospital with known case of cirrhosis
Cirrhotic patients who referred to Liver clinic of Taleghani hospital with Child score A or B
Cirrhotic patients who referred to Liver clinic of Taleghani hospital with no administration of L-Carnitine before
Exclusion criteria:
Not tolerate use of L-Carnitine because of the gastrointestinal problem
Gastrointestinal bleeding
Uncontrolled malignant tumors
Need of hemodialysis
Pregnancy
Receiving drugs causing hyperammonemia
Overt hepatic encephalopathy
Patients who do not accept to continue the study
Patients with other significant background diseases (heart failure, chronic kidney disease,…)
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
120 cirrhotic patients who referred to liver clinic of Taleghani hospital with age 18-70 years old and known cause of cirrhosis with child score A or B and based on inclusion and exclusion criteria will enroll in this study. They will be assigned in three groups with simple randomization. At the end each group will contain 40 patients.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Random assigning will be done by one of our research team and patients, medical doctor and statistician are blind in this study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research institute for gastroenterology and hepatology
Street address
Arabi st., Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2020-12-09, 1399/09/19
Ethics committee reference number
IR.SBMU.RIGLD.REC.1399.049
Health conditions studied
1
Description of health condition studied
Liver cirrhosis
ICD-10 code
K70, K74
ICD-10 code description
Cirrhosis of the liver
Primary outcomes
1
Description
Quality of life
Timepoint
First, 3 months later, 6 months later
Method of measurement
Standard questionnaire for quality life in cirrhotic patients
2
Description
Sarcopenia
Timepoint
First, 3 months later, 6 months later
Method of measurement
Evaluate gripe strength by dynamometer and muscle mass by bioelectrical impedance analysis (BIA).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 1000 mg L Carnitine by Zist Takhmir company will use daily for 24 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: 2000 mg L Carnitine by Zist Takhmir company will use daily for 24 weeks
Category
Treatment - Drugs
3
Description
Control group: Placebo by Zist Takhmir company will use daily for 24 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Leila Pasharavesh
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2521
Email
L.pasharavesh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behzad Hatami MD
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2521
Email
bzd_hatami@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zist takhmir company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Pasharavesh
Position
medical doctor, Researcher
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterologist
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2521
Email
l.pasharavesh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behzad Hatami MD
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterologist
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9982
Email
bzd_hatami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Pasharavesh
Position
Medical doctor, Researcher
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterologist
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9982
Email
L.pasharavesh@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
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
Yes - There is 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
Title and more details about the data/document
data sharing at end of the study
When the data will become available and for how long
At end of the study
To whom data/document is available
researchers
Under which criteria data/document could be used
for other researches
From where data/document is obtainable
Research institute for Gastroenterology and Liver Diseases of SBMU
What processes are involved for a request to access data/document