Protocol summary
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Study aim
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Evaluation and comparison of the effectiveness of silymarin tablet (Levergol) on size of endometrioma lesions and interleukin-6 level in women with ovarian endometriosis before and after intervention
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Design
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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.
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Settings and conduct
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Gynecologists perform in hospitals and offices.
For this purpose, Levergol 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.
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Participants/Inclusion and exclusion criteria
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Iranian married women of reproductive age (15-49); with a confirmed diagnosis of ovarian endometriosis via transvaginal ultrasonography performed by a single sonologist and CA125 level;
No chronic disease based on medical records; without taking specific medications or anti-inflammatory supplements with a specified wash-out period for each one
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Intervention groups
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All participants in the intervention group will receive a dose of 280 mg silymarin including two tablets of Livergol 140 mg, Goldaru Pharma Co. Isfahan-Iran) and women in the control group will receive placebo tablets (Goldaru Pharma Co. Isfahan-Iran) daily in two meals (after breakfast and dinner) for 12 weeks along with standard treatment of endometrioma (dienogest 2mg/day, NSAIDs, estrogen and progesterone). The therapeutic doses of silymarin have been considered safe and well-tolerated in humans without any interaction with endometriosis treatment
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Main outcome variables
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the size of endometrioma lesions; Interleukin 6 levels
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150905023897N5
Registration date:
2020-02-04, 1398/11/15
Registration timing:
prospective
Last update:
2022-02-23, 1400/12/04
Update count:
2
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Registration date
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2020-02-04, 1398/11/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-07, 1398/11/18
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Expected recruitment end date
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2021-03-14, 1399/12/24
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Actual recruitment start date
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2020-03-02, 1398/12/12
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Actual recruitment end date
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2021-05-18, 1400/02/28
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Trial completion date
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2021-08-21, 1400/05/30
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Scientific title
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To evaluate the effectiveness of Silymarin (Livergol) on IL-6 levels and size of endometrioma lesions in women with ovarian endometriosis: a randomized, double-blind placebo-controlled trial
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Public title
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To evaluate the effectiveness of Silymarin (Livergol) on IL-6 levels and size of endometrioma lesions
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Iranian married women of reproductive age (15-49)
No chronic disease (diabetes, hypertension, liver and kidney disease, previous venous embolism ...) based on medical records
Women with a confirmed diagnosis of ovarian endometriosis via transvaginal ultrasonography performed by a single sonologist and CA125 level
People are willing to participate in the study
Exclusion criteria:
participants suffering from the side effects of silymarin
Individuals unwilling to continue participating in the study
Failure to comply with treatment protocol
Taking specific medications such as anti-depressant, GnRH analogues, systemic glucocorticoids, or other milk thistle products and anti-inflammatory supplements with a specified wash-out period for each one
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Age
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From 15 years old to 49 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
60
Actual sample size reached:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization will be done according to a computer-generated list of random number groups prepared using Statistical Analysis System Software Version 9.2 (SAS Institute Inc., Cary, NC, USA). All participants will be randomly allocated to each arm and given the tablets based on a computer-generated randomization list by the investigator.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The researcher and patients will be unaware of the treatment and grouping of the study. For this purpose, Levergol 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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-22, 1398/07/30
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Ethics committee reference number
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IR.MODARES.REC.1398.143
Health conditions studied
1
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Description of health condition studied
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Endometrioma lesions
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ICD-10 code
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N80.1
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ICD-10 code description
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Endometriosis of ovary
Primary outcomes
1
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Description
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Interleukin 6 levels
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Timepoint
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At the beginning of the study and three months after starting the Livergol pill
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Method of measurement
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Using the ELISA method in pg / ml
2
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Description
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Endometrial lesion volume measurement
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Timepoint
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At the beginning of the study and three months after starting the Livergol pill
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Method of measurement
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ultrasound or laparoscopy in millimeters
3
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Description
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Sexual function
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Timepoint
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At the beginning of the study and three months after starting the Livergol pill
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Method of measurement
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Using the FSFI questionnaire
4
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Description
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Quality of Life
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Timepoint
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At the beginning of the study and three months after starting the Livergol pill
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Method of measurement
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Using the SF-12 questionnaire
5
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Description
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Pelvic pain
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Timepoint
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At the beginning of the study and three months after starting the Livergol pill
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Method of measurement
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VAS visual analog scale
Intervention groups
1
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Description
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Intervention group: People in the intervention group receive Liverpool 140 mg tablets at the pharmaceutical company twice daily for three months.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Information on the main outcome of the study
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When the data will become available and for how long
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1400
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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Use for further research in the future
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From where data/document is obtainable
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Email Addressing Responsible for Study
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What processes are involved for a request to access data/document
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Submit a request to study and follow up
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Comments
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