The effect of melatonin supplementation with progesterone on the improvement and level of inflammatory factors in patients with endometrial hyperplasia
The effect of melatonin supplementation with progesterone on the improvement and level of inflammatory factors in patients with endometrial hyperplasia
Design
A clinical trial with a randomized three-blind control group performed on 20 people.
Settings and conduct
The present study is a three-way blind with random assignment using a random number table.
Participants/Inclusion and exclusion criteria
Patients with endometrial atypical hyperplasia, without a history of treatment, referred to the clinic of Beheshti Hospital in Kashan, after obtaining informed consent
Intervention groups
The case group contains two 5 mg medroxyprogesterone tablets and two 10 mg melatonin tablets.
Main outcome variables
Pathological manifestations of the uterus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220116053735N1
Registration date:2022-06-19, 1401/03/29
Registration timing:registered_while_recruiting
Last update:2022-06-19, 1401/03/29
Update count:0
Registration date
2022-06-19, 1401/03/29
Registrant information
Name
Neda Aslany
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3788 4890
Email address
aslany-n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin supplementation with progesterone on the improvement and level of inflammatory factors in patients with endometrial hyperplasia
Public title
The effect of melatonin supplementation with progesterone on the improvement and level of inflammatory factors in patients with endometrial hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with endometrial atypical hyperplasia,
without a history of treatment,
referred to the clinic of Beheshti Hospital in Kashan,
Exclusion criteria:
Pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in the form of a table of random numbers.
Random number table is a set of numbers that are produced without a specific pattern or order and in a completely random manner and has become a table. To use a table of random numbers, the table is first pre-set for reading numbers (for example, up, down, left, or right), the second assumption is to consider numbers for different groups (for example, even numbers for intervention A and Individual numbers for intervention B) Then the researcher touches one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Due to the fact that in the present study, placebo was used to eliminate any bias in the effectiveness of drugs, participants, researchers and clinical caregivers were blinded. Each participant is assigned a code based on the type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan
City
Kashan
Province
Isfehan
Postal code
8565215487
Approval date
2021-12-05, 1400/09/14
Ethics committee reference number
IR.KAUMS.REC.1400.051
Health conditions studied
1
Description of health condition studied
Hyperplasia
ICD-10 code
E32.0
ICD-10 code description
Persistent hyperplasia of thymus
Primary outcomes
1
Description
One consequence of the study is the lack of observation of hyperplastic lesions in pathology examination and report of secondary pathology. Another consequence is an increase in the levels of the above inflammatory factors in re-testing by ELISA at the end of the fourth month of treatment.
Timepoint
monthly
Method of measurement
In this study, interviews and observations and researcher-made checklists were used.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Two medroxyprogesterone 5 mg tablets (manufactured by Caspian) and two 10 mg melatonin tablets (manufactured by Galenus) are given every night from the fifteenth day of the cycle for two weeks to three one-month periods.
Category
Treatment - Drugs
2
Description
Control group: Two medroxyprogesterone 5 mg tablets and two placebo tablets are prescribed every night from the fifteenth day of the cycle for two weeks to three one-month periods.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti Hospital
Full name of responsible person
Neda Aslany
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
8565214571
Phone
+98 916 290 7375
Email
aslany-@Kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafsheh
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
8565211122
Phone
+98 916 290 7375
Email
aslany-n@Kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Aslany
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
8565215532
Phone
+98 916 290 7375
Email
aslany-n@Kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Aslany
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
8565213265
Phone
+98 916 290 7375
Email
aslany-n@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Aslany
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 403,mehregan building, koohe noor Ave., Shafaq Blvd., Keshavarz Blvd
City
Isfahan
Province
Isfehan
Postal code
8565213265
Phone
+98 31 3788 4890
Fax
Email
aslany-n@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Get permission from the project manager
From where data/document is obtainable
By email
What processes are involved for a request to access data/document