The effect of supplementation with Amino selenium on the course of the disease, painful signs and symptoms in women with endometriosis: A triple blind randomized controlled trial
To determine the effect of supplementation with Amino Selenium on the course of the disease, painful symptoms and signs in women with endometriosis
Design
A clinical trial with a control group, parallel group,triple-blind, randomized, phase 3 on 66 patient. The stratified random block method was used for randomization.
Settings and conduct
This study will be conducted on 66 women with endometriosis who have a case file at the Gynecology and Obstetrics Clinic of Al-Zahra Medical Training Center and Sheikh Al-Raees Specialized Clinic in Tabriz. The intervention group will be given organic selenium and the control group will be given placebo capsules. At the beginning of the intervention, the participants will be reminded that the next follow-up will be every month after the start of the intervention for 3 months, so that in the first month, once a week, and in the second and third months, once every two weeks, the participants will be contacted by phone and consumed the drug or placebo will be reminded and they will be asked to check the drug consumption checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women with symptomatic endometriosis
Exclusion criteria:
Definite need for surgery based on the opinion of obstetrician and gynecologist
Intervention groups
In this study, one group will receive amino selenium as the intervention groups and for the control group will receive placebo daily for three months. Both groups will be given routine treatment (Verogest 2 mg once a day for six months).
Main outcome variables
Average endometrioma cyst size 3 months after starting the treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110606006709N26
Registration date:2023-12-30, 1402/10/09
Registration timing:prospective
Last update:2023-12-30, 1402/10/09
Update count:0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-19, 1402/10/29
Expected recruitment end date
2024-06-18, 1403/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplementation with Amino selenium on the course of the disease, painful signs and symptoms in women with endometriosis: A triple blind randomized controlled trial
Public title
Investigating the effect of amino selenium in the treatment of endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age (15-49 years)
Being literate in reading and writing
Women with primary endometriosis with endometrioma less than 5 cm
Women with symptomatic endometriosis (dysmenorrhoea pain score of 16 or more in the Mous Menstrual Distress Questionnaire)
Married women who are sexually active
Exclusion criteria:
Probability of malignancy based on vaginal ultrasound
Definite need for surgery based on the opinion of obstetrician and gynecologist
Suffering from diseases such as myoma or hyperplasia or polycystic ovary syndrome based on vaginal ultrasound
Daily and regular consumption of supplements containing Amino Selenium during the last three months according to the patient's statement
Suffering from liver and kidney diseases and the need for dialysis
Pregnancy and breastfeeding
Desire to get pregnant in the next trimester
Allergy to Gelofen
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly chassified by the block method with a block size of four and six and a ratio of 1:1 allocation in tow intervention (Amino selenium) and control (placebo) groups. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program.
Blinding (investigator's opinion)
Triple blinded
Blinding description
People involved in sample selection, data collection, analysis and the participants will be blinded. Amino selenium and placebo will be prepared by Tabriz nutrition research center in a completely similar way in terms of apprearance and; the usage method will be the same. Blocking will be done by a person not involved in sampling. In order to concealment allocation, drugs and placebo will be placed in completely identical falcons randomly and allocated by a person not involved in the study, which will be consecutively numbered from 1 to 66.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.TBZMED.REC.1402.570
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Average endometrioma cyst size
Timepoint
Before the intervention and 3 months after the start of intervention
Method of measurement
Vaginal ultrasound
2
Description
Average dysmenorrhea score
Timepoint
Monthly during 3 months (1, 2, 3 months) after the start of the intervention
Method of measurement
Mous Menstrual Distress Questionnaire (MMDQ)
Secondary outcomes
1
Description
Average dyspareunia score
Timepoint
Monthly during 3 months (1, 2, 3 months) after the start of the intervention
Method of measurement
Visual analog scale (VAS)
2
Description
Average score of dysuria
Timepoint
Monthly during 3 months (1, 2, 3 months) after the start of the intervention
Method of measurement
Visual analog scale (VAS)
3
Description
Average score of Dyschezia
Timepoint
Monthly during 3 months (1, 2, 3 months) after the start of the intervention
Method of measurement
Visual analog scale (VAS)
4
Description
Average score of non cyclic pain
Timepoint
Monthly during 3 months (1, 2, 3 months) after the start of the intervention
Method of measurement
Visual analog scale (VAS)
Intervention groups
1
Description
Intervention group: A 250 mg capsule containing 200 µg of amino selenium enriched with Saccharomyces cerevisiae yeast was made at the Tabriz Nutrition Research Center and will be used once a day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: A 250 mg capsule containing Saccharomyces cerevisiae yeast was made at the Tabriz Nutrition Research Center and one capsule will be used daily for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra educational hospital
Full name of responsible person
Mahnaz Shahnazi
Street address
Alzahra Hospital, Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
nursing@tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
Sheykh Al-Rais clinic
Full name of responsible person
Mahnaz Shahnazi
Street address
Sheikhalrayis clinic, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3336 6215
Email
mshahnazi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Research department, third floor, central construction number 2,Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Teihoomanesh fard
Position
Student of master's degree in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5415933739
Phone
+98 41 3475 3906
Fax
+98 41 3475 3906
Email
ftmf.97@gmail.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 2699
Fax
+98 41 3479 6969
Email
mshahnazi@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Teihoomanesh fard
Position
Student of master's degree in Tabriz
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5415933739
Phone
009841344753906
Fax
+98 41 3479 6969
Email
ftmf.97@gmail.com
Web page address
http://nursing.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD