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The Effect of Cumin Vaginal Cream on Vaginal Atrophy, Sexual Function Index and Sexual Distress in Postmenopausal Women, Gonanbad –2022

Protocol summary

Study aim
Determining the effect of cumin vaginal cream on vaginal atrophy, sexual function and sexual distress of postmenopausal women
Design
A three-blind clinical trial
Settings and conduct
This study will be conducted in Gonabad city in health centers. The study will be triple-blind, and the researcher, the analyst, and the participant will be unaware of the content of the worms
Participants/Inclusion and exclusion criteria
Entry criteria: age between 45 and 65 years, passing 1 to 2 years since menopause, having a minimum education degree with literacy, having informed consent to participate in the research, married and monogamous, no history of pelvic surgery, no Drug and alcohol use by the woman and her husband, no use of estrogenic drugs, no vaginal bleeding, no history of radiation therapy or chemotherapy of the pelvis or the whole body, no history of cancer, no history of infertility, no history of premature ejaculation or impotence. , not having sexual problems in relationship with your spouse, not having vaginal infections, not having psychological disorders such as: psychosis, schizophrenia, delirium, etc., having at least 2 symptoms from the descriptive evaluation table of vaginal mucosa . Obtaining a score of 23 or less according to the sexual function index questionnaire (FSFI), absence of diabetes. The criteria for withdrawal from the study during the research include: sensitivity to cumin vaginal cream, consumption of any drug that affects sexual function during the study, starting to take hormonal drugs during the research, experience of unfortunate or stressful events in the woman or her husband,
Intervention groups
Cumin vaginal cream 5% is used in the amount (one gram) of one fifth of the applicator for eight weeks (six weeks every night and the next two weeks every other night).
Main outcome variables
Vaginal atrophy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220926056043N1
Registration date: 2022-09-30, 1401/07/08
Registration timing: prospective

Last update: 2022-09-30, 1401/07/08
Update count: 0
Registration date
2022-09-30, 1401/07/08
Registrant information
Name
Fatemeh Kermani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 770 1543
Email address
fatemekermani835@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cumin Vaginal Cream on Vaginal Atrophy, Sexual Function Index and Sexual Distress in Postmenopausal Women, Gonanbad –2022
Public title
The Effect of Cumin Vaginal Cream on Vaginal Atrophy, Sexual Function Index and Sexual Distress in Postmenopausal Women, Gonanbad –2022
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45 and 65 years 1 to 2 years have passed since menopause Having at least a degree with reading and writing literacy Having informed consent to participate in the research Married and monogamous No history of pelvic surgery (according to the participant's statement) Non-use of drugs and alcohol in the woman and her husband (according to the participant's statement) Not taking estrogenic drugs Absence of vaginal bleeding No history of radiation therapy or chemotherapy of the pelvis or the whole body No cancer No history of infertility (according to the participant's statement) Absence of spouse suffering from premature ejaculation or impotence (according to the participant's statement) Absence of vaginal infections (based on the participants' statements and questions about the clinical symptoms of vaginitis) Not suffering from psychological disorders such as: psychosis, schizophrenia, delusions, etc. (according to the participant himself) Having at least 2 symptoms from the descriptive evaluation table of the vaginal mucosa (color, roughness, petechiae, elasticity, dryness) Obtaining a score of 23 or less according to the Sexual Performance Index (FSFI) questionnaire Not having diabetes (according to the participant's statement)
Exclusion criteria:
Allergy to cumin vaginal cream Taking any medication affecting sexual performance during the study Starting to take hormonal drugs during the study Experiencing unfortunate or stressful events in a woman or her husband Dissatisfaction to continue cooperation in research Absence of diseases in women or their spouses that affect sexual performance (such as premature ejaculation, cardiovascular, mental, thyroid and cancers) Getting stressed (such as divorce, infidelity of a spouse, death of loved ones in the last year, serious illnesses or imprisonment)
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
After sampling by available method, randomization is done by block randomization method. The size of all blocks is equal (8 pieces). And in each block (one in the middle) 4 participants will receive vaginal cream with code A and 4 participants will receive vaginal cream with code B (researcher, participant and analyst are unaware of the contents of the creams)
Blinding (investigator's opinion)
Triple blinded
Blinding description
After making the cream and placebo by Mashhad pharmacology specialist, the creams are poured into the tubes coded A and B, and the researcher, participant, analyst will be unaware of the content of the creams.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Imam Khomeini, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2022-09-26, 1401/07/04
Ethics committee reference number
IR.GMU.REC.1401.067

Health conditions studied

1

Description of health condition studied
Vaginal atrophy
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis

Primary outcomes

1

Description
Vaginal atrophy
Timepoint
Before, 4 and 8 weeks after the intervention
Method of measurement
Descriptive assessment of vaginal mucosa

2

Description
sexual function
Timepoint
Before, 4 and 8 weeks after the intervention
Method of measurement
Female Sexual Function Index

3

Description
Women's sexual distress
Timepoint
Before, 4 and 8 weeks after the intervention
Method of measurement
Female Sexual Distress Scal

4

Description
Vaginal atrophy daily effects
Timepoint
Before, 4 and 8 weeks after the intervention
Method of measurement
Vaginal atrophy daily effects questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: The control group used one-fifth of an applicator (one gram) of vaginal cream every night for six weeks and in the next two weeks every other night. At the end of the 4th and 8th week, follow-up will be done again, including clinical examination and filling in the questionnaires of women's sexual function index, the questionnaire of daily effects of vaginal atrophy and the questionnaire of women's sexual distress.
Category
Placebo

2

Description
Intervention group: The intervention group used one-fifth of an applicator (one gram) of vaginal cream every night for six weeks and in the next two weeks every other night. At the end of the 4th and 8th week, follow-up will be done again, including clinical examination and filling in the questionnaires of women's sexual function index, the questionnaire of daily effects of vaginal atrophy and the questionnaire of women's sexual distress.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health centers in Gonabad
Full name of responsible person
Fatemeh kermani
Street address
Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3514
Email
info@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Postgraduate education expert
Street address
Gonabad University of Medical Sciences, Imam Khomeini, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
6535149413
Phone
+98 51 5722 5027
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
30
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
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh kermani
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
6535149413
Phone
+98 51 5722 5027
Email
fatemekermani835@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narjes bahri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
6535149413
Phone
+98 51 5722 5027
Email
nargesbahri@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh kermani
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
6535149413
Phone
+98 51 5722 5027
Email
fatemekermani835@gmail.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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The participants are coded to increase access to them and their information, and at the time of publication, only the main result is published, and the information of the participants is not published in any way.
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
Access is open to the public.
Under which criteria data/document could be used
If a person has a request, without mentioning the coding of the information in a confidential manner, without the personal information of the person, only the main and secondary results will be provided to the requester.
From where data/document is obtainable
Gmail
What processes are involved for a request to access data/document
First, the applicant should send a message to the e-mail and state the reason for using the data. And within a week, the information will be sent to the applicant with conditions and restrictions.
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