Evaluation of the efficacy and safety of Detoxil (a herbal medicine) in improving liver function in liver injury
Design
A randomized, placebo-controlled, double-blinded, parallel phase 3 clinical trial
Settings and conduct
In this study, 100 eligible patients admitted to Baqiyatallah Hospital who have obtained their informed and informed consent will participate the study.
Patients are randomly divided into two groups intervention and control with an equal sample size (50:50).
Each patient will be in the study for 5 days.
Before and after the intervention, the patient will be evaluated and the results will be recorded in the form and at the end will be analyzed through SPSS software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The patient must be over 18 years old; The patient's Child-Pugh score is category B and C; The patient or his / her companion has informed and free written consent to participate in the study.
Exclusion criteria:
Pregnancy; Breastfeeding; History of previous allergies to any of the active ingredients of the drug; Concomitant presence in another clinical study;
Intervention groups
Intervention group: oral Detoxil capsule 400mg, 1 capsule every 12 hours, for 5 days.
Placebo group: oral Placebo capsule 400mg, 1 capsule every 12 hours, for 5 days.
Main outcome variables
Changes in serum level of ALT enzyme;
Changes in serum level of AST enzyme;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N68
Registration date:2022-09-14, 1401/06/23
Registration timing:prospective
Last update:2022-09-14, 1401/06/23
Update count:0
Registration date
2022-09-14, 1401/06/23
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of Detoxil (a herbal medicine) in improving liver function in liver injury
Public title
Evaluation of efficacy and safety of Detoxil capsules in patients with liver injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has informed and free written consent to participate in the study;
Age between 18-80;
The patient's Child-Pugh score is category B or C;
Exclusion criteria:
Pregnancy;
Breastfeeding;
Participate in another clinical trial at the same time;
History of previous allergies to any of the components of the drug;
Age
From 25 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients.
In this method, the number of people assigned to each group is usually almost equal. Blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as witnesses. The main goal in this method is to balance the number of participants in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The placebo looks the same as the original drug, provided by the drug company.
In this study, the prescribing physician, patient, therapeutic team, data collector, and statistical analyzer are unaware about type of intervention (intervention / placebo).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah Hospital
Street address
Baqiyatallah Hospital, Mollasadra Ave., Vanak
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2022-04-12, 1401/01/23
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.002
Health conditions studied
1
Description of health condition studied
Diseases of liver
ICD-10 code
K76.9
ICD-10 code description
Liver disease, unspecified
Primary outcomes
1
Description
AST serum level
Timepoint
Before and after intervention
Method of measurement
Blood sample
2
Description
ALT serum level
Timepoint
Before and after intervention
Method of measurement
Blood sample
Secondary outcomes
1
Description
Bilirubin serum level
Timepoint
Before and after the intervention
Method of measurement
Blood sample
2
Description
Child-Pugh score
Timepoint
Before and after the intervention
Method of measurement
Child-Pugh score classification
Intervention groups
1
Description
Intervention group: oral Detoxil capsules 400mg, 1 capsule, every 12 hours for 5 days. Detoxil capsules are prepared by Tabib-Daru Pharmaceutical Company (located at Kashan) and contain hydroalcoholic extracts of sage, artichoke, dandelion and poppy extract with the 1:1 ratio.
Category
Treatment - Drugs
2
Description
Control group: oral placebo capsule 400mg, 1 capsule every 12 hours for 5 days. he placebo capsule with a appearance completely similar to the main drug has been prepared by Tabib-Daru Pharmaceutical Company (located at Kashan).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Yunes Panahi
Street address
Mollasadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Fax
+98 21 8245 5393
Email
yunespanahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Zarei Abarghouee
Street address
Baqiyatallah University of Medical Science, Mollasadra Ave., Vanak
City
Tehran
Province
Tehran
Postal code
193955487
Phone
+98 21 8755 5250
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabib daru pharmaceutical company
Proportion provided by this source
50
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Kianpour
Position
Fellowship in Critical care Pharmacotherapy
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
16 Azar St., Enghelab Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 64120
Fax
Email
Parisa_kianpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Critical care pharmacotherapy
Street address
Mollasadra St. Vanak Sq. Tehran
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8821 1524
Fax
+98 21 8821 1524
Email
yunespanahi@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Siamak musazadeh
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Baqiyatallah University of Medical Science, Mollasadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8245 5393
Fax
+98 21 8245 5393
Email
siamakpirlo2580@gmail.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