Evaluation the effect of Cichorium intybus L. on change the liver enzymes in burn patients: a randomized double- blind placebo-controlled clinical trial
Evaluation the effect of Cichorium intybus L. on change the liver enzymes in burn patients
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
A study on burn patients hospitalized in Amiralmomenin Hospital will be conducted; a double blinded study that neither patients nor researcher know about their reviving drug.
Participants/Inclusion and exclusion criteria
Patients in range of 20-75 years old that their burn duration is less than 2 days and burn percentage is 10%-50%; not intubated; do not have hepatitis, hyperlipidemia, history of seizure, and not pregnant.
Intervention groups
Intervention group: Cichorium intybus L is bought from market of medicinal plants. Once verified by the botanist, it is used to prepare herbal extracts.so the Cichorium intybus L is bold ten times the volume with water. For condensation, the rotary machine will be used and then converted to the powder by freeze-dried process. To make syrup, the powder is mixed with honey and other ingredients. After considering the appropriate formulation and having organoleptic properties suitable packaging is done.The dosage for patients will be equivalent to 6 grams of chicory seeds per day. Patients should take medication for a maximum of 4 weeks.
Control group:chicory seeds will be provide With a much lower dose of the therapeutic dose.
Main outcome variables
The level of ALT, AST, Alb, CRP, creatinine and urea patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180609040016N1
Registration date:2018-06-18, 1397/03/28
Registration timing:prospective
Last update:2018-06-18, 1397/03/28
Update count:0
Registration date
2018-06-18, 1397/03/28
Registrant information
Name
Abdolkhalegh Keshavarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3614 6521
Email address
keshavarzg@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
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
Evaluation the effect of Cichorium intybus L. on change the liver enzymes in burn patients: a randomized double- blind placebo-controlled clinical trial
Public title
Evaluation the effect of Cichorium intybus L. on change the liver enzymes in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The burn time for patients is less than two days
Their burn are is between 10% - 50% body surface percentage
Exclusion criteria:
The patients are not intubated
No history for liver disease, hyperlipidemia, seizure
No pregnancy
Age
From 20 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is random balanced blocks with four sample in each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Neither the patient nor the researcher knows the nature of the drugs received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.SUMS.REC.1396.194
Health conditions studied
1
Description of health condition studied
Liver disorder
ICD-10 code
76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
ALT level
Timepoint
Every 3 days until discharg
Method of measurement
Biochemistry analysis
2
Description
AST level
Timepoint
Every 3 days until discharg
Method of measurement
Biochemistry analysis
3
Description
َAlbumin level
Timepoint
Every 3 days until discharg
Method of measurement
Biochemistry analysis
4
Description
CRP level
Timepoint
Every 3 days until discharg
Method of measurement
Biochemistry analysis
5
Description
Creatinin level
Timepoint
Every 3 days until discharg
Method of measurement
Biochemistry analysis
6
Description
Urea level
Timepoint
Every 3 days until discharg
Method of measurement
Biochemistry analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: : Cichorium intybus L is bought from market of medicinal plants. Once verified by the botanist, it is used to prepare herbal extracts.so the Cichorium intybus L is bold Ten times the volume with water. For condensation, the rotary machine will be used and then converted to the powder by freeze-dried process. To make syrup, the powder is mixed with honey and other ingredients.After considering the appropriate formulation and having organoleptic properties suitable packaging is done.The dosage for patients will be equivalent to 6 grams of chicory seeds per day.Patients should take medication for a maximum of 4 weeks
Category
Treatment - Other
2
Description
Control group: chicory seeds will be provide with a much lower dose of the therapeutic dose.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital of burn injury and wound healing of Amir al-Momenin
Full name of responsible person
Abdlokhalegh Keshavarzi
Street address
Training center for burn injuries amiralmomenin, Km 2 Sadra
City
Shirz
Province
Fars
Postal code
7198754361
Phone
+98 71 3614 6100
Email
keshavarzi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abdlokhalegh Keshavarzi
Street address
Central department of shiraz university of medical science, Zand Ave.
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
keshavarzi@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Abdlokhalegh Keshavarzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Central building of shiraz university of medical sciences, Zand Ave.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
keshavarzi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rahimeh Akrami
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hospital of burn injury and wound healing of Amir al-Momenin
City
shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3614 6100
Email
rahimeh.akrami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Rahimeh Akrami
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Training center for burn injuries amiralmomenin, Km 2 Sadra
City
shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3614 6100
Email
rahimeh.akrami@yahoo.com
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