Effects of oral Shilajit tablet on sexual function and sexual quality of life among married women of reproductive age: A triple blind; randomized; controlled; clinical trial study
Determining the effect of oral Shilajit pill on performance and sexual quality of married women of reproductive age
Design
The clinical trial with the control group will be divided into two groups of intervention and control with parallel groups, three-way blind, randomized, phase 1 per 100 people and for randomization by block randomization method
Settings and conduct
.In the first stage, the researcher, after obtaining the necessary permits from the Vice Chancellor for Research, Tarbiat Modares School of Medical Sciences, University Ethics Committee, registers the research project in the IRCT system, by referring to health centers and health centers affiliated to Qom University of Medical Sciences. Research will be conducted to collect samples.
Participants/Inclusion and exclusion criteria
Women aged 45-18 yearsWomen aged 45-18 years
Being Iranian and living in Tehran
Be literate
Husband monogamy and living with the spouse now and during the study
Having sex in the last two months
No underlying disease
Do not have mental illness
Couples not addicted to drugs and alcohol
Do not take drugs that affect sexual function
Have no history of being a rape victim
Sensitivity to shilajit
Do not be pregnant or breastfeeding
Not wanting to stay in the study
Do not take shilajit pills regularly
Active wound or lesion in the genital area
Intervention groups
The intervention group is the group that takes the pill and the control group is the group that will take the placebo. Necessary training on taking medication and placebo will be given to both groups face to face. Shilajit tablets with a dose of 200 mg will be taken twice a day for 60 days, and in the third month only the shelf life and effectiveness of the drug will be evaluated.
Main outcome variables
Evaluation of women's sexual function with the FSFI questionnaire; Evaluation of women's sexual quality of life with SQOL_F questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200617047808N1
Registration date:2020-11-26, 1399/09/06
Registration timing:registered_while_recruiting
Last update:2020-11-26, 1399/09/06
Update count:1
Registration date
2020-11-26, 1399/09/06
Registrant information
Name
sediqa Mosavi
Name of organization / entity
The university of tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 25 3778 2607
Email address
sediqa.mosavi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-05, 1399/08/15
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of oral Shilajit tablet on sexual function and sexual quality of life among married women of reproductive age: A triple blind; randomized; controlled; clinical trial study
Public title
Effect of oral shilajit pill on female sexual function and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 45-18 years
Iranian and living in Tehran
Literacy in Persian
Husband monogamy and living with the spouse now and during the study
Having sex in the last two months(According to the research unit)
No known underlying disease (diabetes, hypertension, asthma, heart disease, thyroid, pelvic visceral prolapse, tumor, other medical diseases, hyperlipidemia ...)
Do not have mental illness(According to the research unit or file)
Couples not addicted to drugs and alcohol(According to the research unit or file)
Do not use drugs that affect sexual function in the questionnaire (according to the research unit or file)
Have not had a stressful accident in the past month (according to the research unit)
Do not have a urinary tract infection (according to a recent research unit or test)
No vaginitis, cervicitis, pelvic genital pain disorders, active wound or genital lesion that interferes with sexual intercourse (penetration) (according to the examination and according to the statement of the research unit or file)
Has no history of being a rape victim (according to the research unit)
Has no history of infertility (according to the research unit)
No history of pelvic surgery (colpuraphy or correction according to the research unit or file)
Not sensitive to shellac or its compounds (according to the research unit)
Not pregnant or breastfeeding (according to the research unit)
Exclusion criteria:
Not wanting to stay in the study
Do not take Shilajet tablets regularly (use less than 80% of cases)
Sensitivity to Shilajet pills or side effects during the study (according to the research unit)
Creating an active wound or lesion in the genital area that interferes with sexual intercourse (penetration) during the intervention (according to the research unit)
Consumption of drugs affecting sexual function during the intervention (according to the research unit)
Experience of a stressful incident during the intervention (according to the research unit)
Urinary tract infection, vaginitis, cervicitis, pelvic genital pain disorders, sexual abuse during the intervention (according to the research unit)
Pregnancy during the intervention (according to the research unit or a positive pregnancy test)
Age
From 18 years old to 45 years old
Gender
Female
Phase
1
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Research units of married women of childbearing age who are unlikely and easy to enter the study from the research community according to the entry and exit criteria of research units. In the first stage, the research units will be divided into two groups of intervention and control based on the inclusion and exit criteria of screening and then randomly block using quadruple random blocks. This method strikes a balance in the allocated samples. In this way, we first design blocks of 4 types of available probabilities, so that in each block there are two people from the intervention group and two people from the control group. The number of probabilities in this case will be equal to 6.AABB(1)-BBAA(2)-ABBA(3)- BAAB(4)- BABA(5)- ABAB(6)Then the list of available modes is prepared and numbered by the tutor and we sort the blocks based on random numbers from 1 to 6. Matte envelopes in the package will be used in numbered order to hide the allocation. The researcher randomly picks up the envelopes and then enters the research units into the sampling system in order.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be a phase 1 three-blind clinical trial with placebo control group. The method of blinding is that the researcher and the research units and statistical analysts will also be unaware of the type of drug used and the placebo drug will be prepared by the pharmacist in the same form and with a special code and will be provided to the research units. Participants and researchers will be unaware of the drug codes and only the pharmacist will determine the drug code and after collecting and completing the study, these codes will be decoded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tarbiat modares university
Street address
No.7. Jalal Al Ahmad Street, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
ir.modares.rec.1399.106
Health conditions studied
1
Description of health condition studied
Performance and quality of women's sexual life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function
Timepoint
3 times at intervals of 1 month
Method of measurement
Female Sexual Function Index ( FSFI Questionnaire)
2
Description
sexual quality of life-Female
Timepoint
3 times at intervals of 1 month
Method of measurement
sexual quality of life-Female (SQOL-F) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group is the group that takes 200 mg shilajit tablets.
Category
Treatment - Drugs
2
Description
Control group: The control group is the group that will take the placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qom University Traditional Medicine Health Center
Full name of responsible person
صدیقه موسوی
Street address
Qom, 15 Khordad Blvd., Alley 43. Traditional Medicine Health Center
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 23 7764 0734
Email
sed.mousavi94@gmail.com
Web page address
https://tramed.muq.ac.ir/
2
Recruitment center
Name of recruitment center
Shahid Rouhani Health Center
Full name of responsible person
sediqa mosavi
Street address
Shahid Rouhani St., Alley 4, No. 4
City
qom
Province
Ghoum
Postal code
3714953595
Phone
+98 25 3760 1746
Email
sed.mosavi94@gmail.com
3
Recruitment center
Name of recruitment center
zamimeh Kowsar health center
Full name of responsible person
sediqa mosavi
Street address
No. 19 day st, Farhangian St., corner of Andisheh St., No. 8
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
tarbiat modares university
Full name of responsible person
shadab shahali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
tarbiat modares university,Jalal Al-Ahmad Highway, Faculty of Medical Sciences
City
tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3811
Email
shadab.shahali@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
دانشگاه علوم پزشکی تهران- مرکز تحقیقات مراقبت های پرستاری و مامایی
Full name of responsible person
azam rahmani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tehran - Tohid Square - Mirkhani St. - School of Nursing and Midwifery Tehran - Nursing and Midwifery Research Center
City
tehran
Province
Tehran
Postal code
6459
Phone
+98 21 6105 4566
Fax
Email
arahmani@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
shadab shahali
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Jalal Al-Ahmad Highway, Faculty of Medical Sciences, Tarbiat Modares University
City
tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3811
Email
shadab.shahali@modares.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
Confidentiality
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, including information about the main outcome, can be shared.
When the data will become available and for how long
Access period from 2021
To whom data/document is available
The data will only be available to field researchers
Under which criteria data/document could be used
For further research, researchers can send a written request to the responsible author
From where data/document is obtainable
Corresponding Author, Tarbiat Modares University, Faculty of Medical Sciences, Department of Midwifery and Reproductive Health
What processes are involved for a request to access data/document
After a written request from the responsible author, the request will be sent to the research unit of Tarbiat Modares University and if the rules are complied with, the analyzed data will be provided to the researchers.