Evaluation and comparison of the effect of silymarin tablet (Levergel) on endometrial lesion volume and interleukin-6 inflammatory factor levels in women before and after intervention
Design
they are randomly divided into two groups: A (intervention group) and B (control group).
The sample size required is pilot study of at least 10 patients in each group as a pilot study in Phase II of the clinical trial.
Settings and conduct
Gynecologists perform in hospitals and offices.
For this purpose, Levergel tablets and placebo are coded by a research center. The lead researcher treats patients in a double-blind manner based on the drug package code. The code for the drug package is recorded on the personal information form and the researcher who completes the information form will not be informed of the type of treatment.
Participants/Inclusion and exclusion criteria
Married Women of Iranian Fertility (15-49)
No chronic disease (diabetes, hypertension, liver and kidney disease, previous venous embolism ...) based on medical records
Endometrioma based on gynecologist's diagnosis according to ultrasound and marker CA125
Be willing to participate in the study
Intervention groups
Those in the intervention group received Liverpool 140 mg twice daily for three months, and those in the control group received placebo for exactly three months with exactly the same appearance as the Liverpool tablet and with the same order. All people receive this drug along with their usual treatments (which include painkillers such as NSAIDs or a variety of hormonal compounds including estrogen and progesterone (LD tablets)) with the same treatment protocol according to the treatment of endometrial lesions. There is no drug between conventional endometrioma treatment and Liverpool treatment.
Main outcome variables
Lesion volume; Interleukin 6 levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150905023897N5
Registration date:2020-02-04, 1398/11/15
Registration timing:retrospective
Last update:2020-02-04, 1398/11/15
Update count:2
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
ِDr. Shahideh Jahanian Sadatmahalleh
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4826
Email address
shahideh.jahanian@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of Silymarin (Livergol) on IL-6 levels and endometrioma lesions: A Randomized Double-blind Placebo-controlled Trial
Public title
To evaluate the effect of Silymarin (Livergol) on IL-6 levels and endometrioma lesions: A Randomized Double-blind Placebo-controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian Married Women in Fertility range (15-49)
No chronic disease (diabetes, hypertension, liver and kidney disease, previous venous embolism ...) based on medical records
Endometrioma based on gynecologist's diagnosis according to ultrasound sonography and marker CA125
People are willing to participate in the study
Exclusion criteria:
People with drug side effects.
Individuals unwilling to continue to participate in the study
Failure to comply with treatment protocol
Age
From 15 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study is randomized using permuted block randomization contains 4th block (two participants in experimental group and two participants in placebo group) by the Random allocation software .
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and patient will be unaware of the treatment and grouping of the study. For this purpose, Levergel tablets and placebo are coded by a research center. The lead researcher treats patients in a double-blind manner based on the drug package code. The code for the drug package is recorded on the personal information form, and the researcher who completes the information form will not be informed of the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares university
Street address
Jalal AleAhmad-Nasr, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
111-14115
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.MODARES.REC.1398.143
Health conditions studied
1
Description of health condition studied
Endometrioma lesions
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Interleukin 6 levels
Timepoint
At the beginning of the study and three months after starting the Livergol pill
Method of measurement
Using the ELISA method in pg / ml
2
Description
Endometrial lesion volume measurement
Timepoint
At the beginning of the study and three months after starting the Livergol pill
Method of measurement
ultrasound or laparoscopy in millimeters
3
Description
Sexual function
Timepoint
At the beginning of the study and three months after starting the Livergol pill
Method of measurement
Using the FSFI questionnaire
4
Description
Quality of Life
Timepoint
At the beginning of the study and three months after starting the Livergol pill
Method of measurement
Using the SF-12 questionnaire
5
Description
Pelvic pain
Timepoint
At the beginning of the study and three months after starting the Livergol pill
Method of measurement
VAS visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People in the intervention group receive Liverpool 140 mg tablets at the pharmaceutical company twice daily for three months.
Category
Treatment - Drugs
2
Description
Control group: People in the control group used the placebo for exactly three months with exactly the same appearance of the Levergel tablet twice a day for three months.