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Comparison of the effects of treatment with premarine and clobetasol - premarin in vaginal involvement of GVHD (Graft-versus-host disease) after hematopoietic stem cell transplantation

Protocol summary

Study aim
Determining the effects of treatment with premarin and clobetasol-premarin in the vaginal involvement of graft-versus-host disease (transplant-induced GVHD)
Design
Randomized Clinical trial, with parallel groups, randomized, on 55, which is used for randomization of double blocks.
Settings and conduct
Patients referred to Shariati Hospital in Tehran who underwent bone marrow transplantation. After identifying the patients, the rate of response to steroid and premarin treatment is evaluated. Also, clinical symptoms such as vaginal dryness, burning sensation during urination, pelvic pain, vulva ulcer, vaginal discharge, vaginal inflammation, scar in the clitoris, vaginal shortening, vaginal tightness, vaginal closure (as well as complications due to transplantation, duration The occurrence of GVHD after transplantation, the prevalence of vaginal GVHD) is also recorded. The type of transplanted cells (allogeneic or autologous) is also investigated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who receive a bone marrow cell transplant; have no disease in the genital area before transplantation; have genital involvement including vaginal involvement after bone marrow transplantation; those who have informed consent to participate in the study. Exclusion criteria: patients without informed consent or death during the study.
Intervention groups
In the first group, Peremarin cream is used once a day along with the mold, and in the second group, clobetasol-peremarin combined treatment is used every other day (for 6 weeks).
Main outcome variables
Vaginal involvement of graft-versus-host disease transplant-induced GVHD

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160615028486N3
Registration date: 2022-07-27, 1401/05/05
Registration timing: registered_while_recruiting

Last update: 2022-07-27, 1401/05/05
Update count: 0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
Mansooreh Yaraghi
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 0618
Email address
dr_m_yaraghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-27, 1401/05/05
Expected recruitment end date
2022-09-09, 1401/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of treatment with premarine and clobetasol - premarin in vaginal involvement of GVHD (Graft-versus-host disease) after hematopoietic stem cell transplantation
Public title
Effects of treatment with premarin and clobetasol-premarin in vaginal disease after hematopoietic stem cell transplantation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients undergoing bone marrow transplantation Consent to participate in research
Exclusion criteria:
History of cervical cancer History of uterine,cervical,vaginal congenital anomaly Patient disagreement
Age
From 18 years old to 80 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 55
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by the method of 4 blocks. Patients are assigned to each treatment group in a ratio of 2 : 2.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
6th floor, Centar building of Tehran University of Medical Sciences, Ghods Street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1505

Health conditions studied

1

Description of health condition studied
Graft-versus-host disease (GVHD)
ICD-10 code
D89.81
ICD-10 code description
Graft-versus-host disease

2

Description of health condition studied
Hematopoietic stem cell transplantation
ICD-10 code
T86.5
ICD-10 code description
Complications of stem cell transplant

Primary outcomes

1

Description
Vaginal involvement of graft-versus-host disease
Timepoint
1 year
Method of measurement
Gynecology examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Premarin cream is used once a day along with the mold for 6 weeks.
Category
Treatment - Drugs

2

Description
Intervention group 2: Clobetazol-premarin combined treatment is used every other day (for 6 weeks).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital Gynecology
Full name of responsible person
Mansooreh Yaraghi
Street address
North Kargarst., Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
Dr_m_yaraghi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology
City
Tehran
Province
Tehran
Postal code
14117 13135
Phone
+98 21 8822 1444
Fax
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Yaraghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Kargarst., Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
dr_m_yaraghi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Yaraghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Kargarst., Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
dr_m_yaraghi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Yaraghi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Kargarst., Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
dr_m_yaraghi@yhoo.com

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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic characteristic of patient and main study result
When the data will become available and for how long
Three mounts after publication of result
To whom data/document is available
All people who work in this field
Under which criteria data/document could be used
every time
From where data/document is obtainable
Mansooreh Yaraghi dr_m_yaraghi@yahoo.com
What processes are involved for a request to access data/document
Send an e-mail to Mansooreh Yaraghi
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