Determining the effect of Artemisia absinthium vaginal gel on performance and sexual satisfaction of women of reproductive age
Design
This study is a clinical trial with a control group, with parallel groups, triple blind, randomized on 76 participants. Random allocation software will be used for randomization.
Settings and conduct
This study will be performed on 76 women referred to the gynecology clinic of Imam Reza and Ghaem hospitals of Mashhad University of Medical Sciences. After selecting the participants, the demographic information questionnaire, female sexual function index, Larson sexual satisfaction and Dass-21 are completed by two groups. In this research, the researcher, participants and statistical analyst are blinded. In this way, the drugs that are placed in the same boxes and named by the pharmacist consultant (none of the study people except the pharmacist consultant knows the contents of the boxes) are given to them depending on the group of participants. At the end of the research, are completed the female sexual function index and Larson sexual satisfaction .
Participants/Inclusion and exclusion criteria
Married women 18-45 years old
Having vaginal sex at least once a week
Sexual function score less than 28 and sexual satisfaction less than 50
Intervention groups
In the intervention group, an applicator of 5% Artemisia absinthium vaginal gel will be used for 4 weeks and 3 times a week (before going to bed).
For the placebo group, the same base gel without Artemisia absinthium will be used.
Main outcome variables
Sexual function score
Sexual satisfaction score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210223050471N1
Registration date:2021-02-28, 1399/12/10
Registration timing:prospective
Last update:2021-02-28, 1399/12/10
Update count:0
Registration date
2021-02-28, 1399/12/10
Registrant information
Name
niloofar Hajatpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3686 1224
Email address
hajatpourn982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Artemisia absinthium on sexual performance and satisfaction of women of reproductive age.
Public title
The effectiveness of Artemisia absinthium on sexual performance and satisfaction of women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women 18-45 years old
Minimum literacy
Having conscious satisfaction
Iranian nationality
Resident of Mashhad
Married and only husband's wife
No history of pelvic surgery
Absence of infertility
Do not use drugs and alcohol in a wife or spouse
Absence of any sexual dysfunction in the spouse
Absence of pregnancy and lactation
Do not take drugs that affect sexual function by the wife or spouse
No recent use of hormonal drugs
Having at least once a week of normal vaginal sex
Absence of abnormal vaginal bleeding
Having a regular menstrual cycle with normal bleeding
No history of chemotherapy and radiotherapy to the pelvis or the whole body
Lack of known medical and psychological illnesses affecting the sexual function of oneself or one's spouse
No depression, anxiety, severe stress
Sexual function score less than 28 and sexual satisfaction score less than 50
Exclusion criteria:
Drug allergy
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
The random sequence of samples is done using random allocation software in two groups A and B Which are intervention and control groups. For Allocation concealment will be using sealed envelopes. A number of envelopes are prepared and each of the random sequences is written on a card and the cards inside the envelope are placed in order and the outer surface of the envelopes is numbered in the same order. Then envelope lids are then glued and placed in the box, respectively. At the beginning of the registration of participants, After giving the necessary explanations to each of the participants and obtaining informed consent, one of the envelopes will be opened in order for the eligible participants to arrive, and the assigned group of the participant will be determined.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug is placed in two identical boxes and none of the study subjects will be aware of the contents of the boxes except the pharmacist consultant. Depending on the group of participants, gel A or B, previously named by the pharmacist consultant, is given to participants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vice Chancellor for Research, Qureshi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2021-01-26, 1399/11/07
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.094
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Sexual satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function score
Timepoint
At the beginning of the study and 4 weeks after using the gel
Method of measurement
The Female Sexual Function Index Questionnaire
2
Description
Sexual satisfaction score
Timepoint
At the beginning of the study and 4 weeks after using the gel
Method of measurement
Larson Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Wormwood with the scientific name (Artemisia absinthium) belongs to the Asteraceae family and is one of the warm native plants, especially in the eastern and northern regions of Iran, and is known as Kharagoush, Gondvash, Marwa and Wormwood. Phytochemical studies of wormwood include a variety of chemical compounds including carbohydrates, alkaloids, saponins, phytosterols, proteins, amino acids, tannins, phenolic compounds, flavonoids. In this study, a vaginal gel tube of 100 g of 5% wormwood (equivalent to 250 mg of available extract) is used. Wormwood is purchased from the approved centers of the university and under the supervision of the esteemed pharmacist of the project, after grinding it, it is soaked in 70% hydroalcoholic solution for 3 days. After this, the desired hydroalcoholic extract is filtered and after removing the solvent, the final extract is obtained. Then the vaginal gel of this extract is prepared based on carbapol with a concentration of 5%. For standardization, the product in terms of total phenol will be standardized by spectrophotometric method. Then it is coded and given to women blindly and they are asked to use this gel vaginally for 4 weeks and 3 times a week (before going to bed) and in case of intercourse, 30 minutes before intercourse.
Category
Treatment - Drugs
2
Description
Control group: In the present study, placebo means a base gel (carbapol) without wormwood extract, which is prepared under the supervision of a pharmacist. The appearance of this gel is similar to the worm wood gel. The method of using this gel is similar to the main drug (wormwood gel), 4 weeks and 3 times a week (before going to bed) and in case of intercourse, 30 minutes before sexual intercourse vaginally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Mashhad
Full name of responsible person
Dr. Ali Khorsand Vakilzadeh
Street address
Imam Reza Hospital, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Emamreza@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr. Fatemeh Tara
Street address
Ghaem Hospital, Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafqadi
Street address
Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 2081
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Raheleh Babazadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
pregnancy health
Street address
School of Nursing and Midwifery, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Babazadehr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Raheleh Babazadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
pregnancy health
Street address
School of Nursing and Midwifery, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Babazadehr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Niloofar Hajatpour
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
pregnancy health
Street address
School of Nursing and Midwifery, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91897-63898
Phone
+98 51 3522 3446
Email
HajatpourN982@mums.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
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 data will be shared after it becomes unrecognizable
When the data will become available and for how long
6 months after recording the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
All women with dysfunction and sexual satisfaction
From where data/document is obtainable
Email niloofarhajatpoor@gmail.com Library of Mashhad School of Nursing to Mashhad, ِDaneshgah Street.
What processes are involved for a request to access data/document
First, send a requested email and if you do not respond within a week, you can refer to the library of Mashhad School of Nursing.