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General information
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70
70
2018-12-21, 1397/09/30
2020-02-07, 1398/11/18
20182020-1202-2107 00:00:00
2019-12-21, 1398/09/30
2021-03-14, 1399/12/24
20192021-1203-2114 00:00:00
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2020-03-02, 1398/12/12
2020-03-02 00:00:00
empty
2021-05-18, 1400/02/28
2021-05-18 00:00:00
empty
2021-08-21, 1400/05/30
2021-08-21 00:00:00
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Completion of the sampling process and statistical analysis led us to update the recorded information of different sections of this trial in IRCT. As we have believed that this study might hold enormous potential for improving promising therapeutic agents to benefit patients who are suffering from various manifestations of endometriosis, especially endometrioma.
Unfortunately, while updating the information related to the actual recruitment start/end dates, we noticed an inadvertent error in recording the expected recruitment start and end dates of the sampling, and a need has been felt on the imperative for transparency, accountability in order to fix that error and explain its causes to re-establish researchers’ trust in this clinical trial’s accuracy and reliability.
All available evidence, including the date of approval of this clinical trial in the ethics committee of Tarbiat Modares University (IR.MODARES.REC.1398.143) and the date of entry of the researcher to the master's degree (1397-98 academic year) indicate an inadvertent error in the registration of this study and make the possibility of conducting this study in that time (before registration) unfeasible. We take full responsibility for the situation and all of patients’ consents and questionnaire forms with detailed for the current study are available upon any requests.
In addition, the simultaneous recruiting of patients and the coronavirus pandemic and its lockdown resulted in study participants’ inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up led to prolong sampling process and its postponement.
Completion of the sampling process and statistical analysis led us to update the recorded information of different sections of this trial in IRCT. As we have believed that this study might hold enormous potential for improving promising therapeutic agents to benefit patients who are suffering from various manifestations of endometriosis, especially endometrioma. Unfortunately, while updating the information related to the actual recruitment start/end dates, we noticed an inadvertent error in recording the expected recruitment start and end dates of the sampling, and a need has been felt on the imperative for transparency, accountability in order to fix that error and explain its causes to re-establish researchers’ trust in this clinical trial’s accuracy and reliability. All available evidence, including the date of approval of this clinical trial in the ethics committee of Tarbiat Modares University (IR.MODARES.REC.1398.143) and the date of entry of the researcher to the master's degree (1397-98 academic year) indicate an inadvertent error in the registration of this study and make the possibility of conducting this study in that time (before registration) unfeasible. We take full responsibility for the situation and all of patients’ consents and questionnaire forms with detailed for the current study are available upon any requests. In addition, the simultaneous recruiting of patients and the coronavirus pandemic and its lockdown resulted in study participants’ inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up led to prolong sampling process and its postponement.
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اتمام پروسهی نمونهگیری بیماران و انجام آنالیزهای آماری، ما را بر آن داشت که اطلاعات ثبت شده این کلینیکالترایال را بروز کنیم تا پژوهشگران علاقهمند به نتایج این مطالعه و فیلد اندومتریوز دید جامعتری نسبت به داروهای تاثیرگذار احتمالی بر شدت علائم و سیر پیشرفت این بیماری داشتهباشند.
متاسفانه هنگام ثبت اطلاعات مرتبط با اتمام روند نمونهگیری، متوجه خطای سهوی انجام گرفته در ثبت تاریخ شروع و اتمام مورد انتظار نمونهگیری شدیم و مجبور شدیم تا این مورد را اصلاح کنیم.
تمام شواهد موجود از جمله تاریخ تایید این کارآزمایی بالینی در کمیته اخلاق دانشگاه تربیت مدرس(IR.MODARES.REC.1398.143) و تاریخ ورود پژوهشگر مربوطه به مقطع ارشد (سال تحصیلی98 -1397) دلالت بر خطای انجام گرفته در ثبت این مطالعه دارد
به علاوه، همزمانی انجام نمونهگیری این مطالعه و همهگیری بیماری کووید 19 و قرنطینه ناشی از آن، منجر به طولانی شدن پروسه نمونهگیری و تعویق در آن شد
اتمام پروسهی نمونهگیری بیماران و انجام آنالیزهای آماری، ما را بر آن داشت که اطلاعات ثبت شده این کلینیکالترایال را بروز کنیم تا پژوهشگران علاقهمند به نتایج این مطالعه و فیلد اندومتریوز دید جامعتری نسبت به داروهای تاثیرگذار احتمالی بر شدت علائم و سیر پیشرفت این بیماری داشتهباشند. متاسفانه هنگام ثبت اطلاعات مرتبط با اتمام روند نمونهگیری، متوجه خطای سهوی انجام گرفته در ثبت تاریخ شروع و اتمام مورد انتظار نمونهگیری شدیم و مجبور شدیم تا این مورد را اصلاح کنیم. تمام شواهد موجود از جمله تاریخ تایید این کارآزمایی بالینی در کمیته اخلاق دانشگاه تربیت مدرس(IR.MODARES.REC.1398.143) و تاریخ ورود پژوهشگر مربوطه به مقطع ارشد (سال تحصیلی98 -1397) دلالت بر خطای انجام گرفته در ثبت این مطالعه دارد به علاوه، همزمانی انجام نمونهگیری این مطالعه و همهگیری بیماری کووید 19 و قرنطینه ناشی از آن، منجر به طولانی شدن پروسه نمونهگیری و تعویق در آن شد
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Shahideh Jahanian Sadatmahaleh
Full name of responsible person - Persian: شهیده جهانیان سادات محله
Street address - English: Jalal Al Ahmad Street، Iran
Street address - Persian: جلال آل احمد، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 111-14115
Phone: +98 21 8800 6544
Fax: +98 21 8800 6544
Email: pres@modares.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research Tarbiat Modares University
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه تربیت مدرس
Full name of responsible person - English: Mohammad Javan
Full name of responsible person - Persian: محمد جوان
Street address - English: Jalal Al Ahmad Street، Iran
Street address - Persian: جلال آل احمد، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 111-14115
Phone: +98 21 8800 6544
Fax: +98 21 8800 6544
Email: pres@modares.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research Tarbiat Modares University Name of organization / entity - Persian: معاونت پژوهشی دانشگاه تربیت مدرس Full name of responsible person - English: Shahideh Jahanian SadatmahalehMohammad Javan Full name of responsible person - Persian: شهیده جهانیان سادات محلهمحمد جوان Street address - English: Jalal Al Ahmad Street، Iran Street address - Persian: جلال آل احمد، دانشگاه تربیت مدرس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 111-14115 Phone: +98 21 8800 6544 Fax: +98 21 8800 6544 Email: pres@modares.ac.ir Web page address:
Protocol summary
Study aim
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
Completion of the sampling process and statistical analysis led us to update the recorded information of different sections of this trial in IRCT. As we have believed that this study might hold enormous potential for improving promising therapeutic agents to benefit patients who are suffering from various manifestations of endometriosis, especially endometrioma.
Unfortunately, while updating the information related to the actual recruitment start/end dates, we noticed an inadvertent error in recording the expected recruitment start and end dates of the sampling, and a need has been felt on the imperative for transparency, accountability in order to fix that error and explain its causes to re-establish researchers’ trust in this clinical trial’s accuracy and reliability.
All available evidence, including the date of approval of this clinical trial in the ethics committee of Tarbiat Modares University (IR.MODARES.REC.1398.143) and the date of entry of the researcher to the master's degree (1397-98 academic year) indicate an inadvertent error in the registration of this study and make the possibility of conducting this study in that time (before registration) unfeasible. We take full responsibility for the situation and all of patients’ consents and questionnaire forms with detailed for the current study are available upon any requests.
In addition, the simultaneous recruiting of patients and the coronavirus pandemic and its lockdown resulted in study participants’ inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up led to prolong sampling process and its postponement.
Acronym
IRCT registration information
IRCT registration number:IRCT20150905023897N5
Registration date:2020-02-04, 1398/11/15
Registration timing:prospective
Last update:2021-10-25, 1400/08/03
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
2020-02-07, 1398/11/18
Expected recruitment end date
2021-03-14, 1399/12/24
Actual recruitment start date
2020-03-02, 1398/12/12
Actual recruitment end date
2021-05-18, 1400/02/28
Trial completion date
2021-08-21, 1400/05/30
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
Actual sample size reached:
70
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
11114115
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.