The aim of this study was to check impact of Silimarina (Livergo) on liver enzymes in patients taking Isotretinoin. Inclusion criteria included: Acne; treatment with isotretinoin and aged between 15 -50.Exclusion criteria included: Liver disease; history of alcohol use; pregnancy and sensitivity to Livergo. This is a double-blind clinical trial. 70 patients with acne that consumer isotretinoin were divided into two groups randomly, intervention (n=35) and control (n=35) groups. At baseline, levels of liver enzyme were measured. Then, 140 mg Livergol capsules daily were given to the intervention group for 30 days. Also Starch capsules daily were given to the intervention group for 30 days. The liver enzymes were measured after study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080814229N5
Registration date:2016-09-02, 1395/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-02, 1395/06/12
Registrant information
Name
Hadi Jafari manesh
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
jafarimanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of Silimarina (Livergo) with placebo on liver enzymes in patients taking Isotretinoin
Public title
Effect of Silimarina (Livergo) on liver enzymes in patients taking Isotretinoin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: Acne; treatment with isotretinoin; aged between 15 -50 and Consent to participate in research. Exclusion criteria included:
Liver disease; history of alcohol use; pregnancy and sensitivity to Livergo.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Basij Sq. Arak
City
Arak
Postal code
3819693345
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
93-175-17
Health conditions studied
1
Description of health condition studied
آکنه
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Alanine Transaminase
Timepoint
Before and after 30 days
Method of measurement
U/L - Laboratory kit
2
Description
Aspartate transaminase
Timepoint
Before and after 30 days
Method of measurement
U/L - Laboratory kit
3
Description
Alkaline Phosphatase
Timepoint
Before and after 30 days
Method of measurement
U/L - Laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Group 1 (intervention): 140 mg Livergol capsules daily for 30 days
Category
Treatment - Drugs
2
Description
Group 2 (control):Starch capsules daily for 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Hadi Jafari Manesh
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpou
Street address
Basij Sq. Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
nurse_science@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
nurse_science@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafari Manesh
Position
Master of Nursing
Other areas of specialty/work
Street address
Basij Sq. Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)