The effect of ethanolic extract of Elaeagnus angustifolia flower on sexual dysfunction in women with multiple sclerosis (MS): A double-blind randomized clinical trial
Determining the effect of ethanolic extract of Elaeagnus angustifolia flower on sexual dysfunction in women with MS referring to the MS clinic of Shefa Hospital - Kerman
Design
This research, in the form of a double-blind randomized clinical trial, will investigate the effectiveness of Elaeagnus angustifolia flower extract on sexual dysfunction in women with MS.
Settings and conduct
This research will be conducted in the MS clinic of Shefa-Kerman Hospital on at least 92 MS patients with sexual dysfunction. After packaging, the drug and placebo will be coded as A and B by the pharmacist. These codes will be attached with a label on the drug and placebo package. Only pharmacists and biostatisticians will know how to assign these codes to drugs and placebos. Then they will be provided to the researcher. Neither the researcher nor the patient will know how to assign the codes to the drug or placebo. Finally, the codes and data will be provided to a statistician and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with MS of reproductive age and married with a constant sexual partner
Sexual dysfunction confirmed by the test (Female Sexual Function Index (FSFI).
Normal pelvic examination
Pap smear negative in the last six months
Natural examination of the breasts
Exclusion criteria: suffering from a serious disease other than MS, Any history of genital or gastrointestinal or breast cancer,
Suffering from depression or other mental disorders and taking antidepressants
Pregnancy and breastfeeding
Intervention groups
The drug group will receive 500 mg capsules containing Elaeagnus angustifolia flower extract powder and the placebo group will receive 500 mg capsules containing starch for two months.
Main outcome variables
Severity of sexual dysfunction
General information
Reason for update
Acronym
MS
IRCT registration information
IRCT registration number:IRCT20161108030776N4
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Mohadese Kamali
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 2827
Email address
mohadesekamali0912@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ethanolic extract of Elaeagnus angustifolia flower on sexual dysfunction in women with multiple sclerosis (MS): A double-blind randomized clinical trial
Public title
The effect of Elaeagnus angustifolia flower on female sexual dysfunction in MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with MS in reproductive age and meta-males who have a constant sexual partner
Sexual dysfunction confirmed by the test (Female Sexual Function Index (FSFI)
Normal pelvic examination
Pap smear negative in the last six months
Normal breast examination
Exclusion criteria:
Suffering from a serious disease other than MS (any disease other than MS that requires the participant to use non-MS medications during the study)
Any history of genital or gastrointestinal or breast cancer
pregnancy and breastfeeding
Suffering from depression or other mental disordersand taking antidepressants
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two equal intervention and control groups using the random block method of four, and the codes of the patients will be provided to the biostatistics specialist and will not be opened until the end of the intervention period of the last patient and analysis.
Blinding (investigator's opinion)
Double blinded
Blinding description
After packaging, the drug and placebo are coded as A and B by the pharmacist, and these codes will be attached with a label on the drug and placebo package. Only pharmacists and biostatisticians will know how to assign these codes to drugs and placebos. Then they will be provided to the researcher. Neither the researcher nor the patient knows how to assign codes to drugs or placebos. Finally, the codes and data will be provided to the statistician and the analysis will be done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.KMU.REC.1401.020
Health conditions studied
1
Description of health condition studied
Sexual dysfunction in multiple sclerosis
ICD-10 code
F54
ICD-10 code description
Psychological and behavioral factors associated with disorders or diseases classified elsewhere
Primary outcomes
1
Description
Severity of sexual dysfunction
Timepoint
The beginning of the study, one month after the start of the study and the end of the study
Method of measurement
Female Sexual Function Index (FSFI) questionnaire
2
Description
quality of life
Timepoint
The beginning of the study, one month after the start of the study and the end of the study
Method of measurement
Questionnaire of the quality of life of MS patients named MSQOL54
3
Description
Temperament type
Timepoint
The beginning of the study
Method of measurement
Salmannejad temperament standard questionnaire
Secondary outcomes
1
Description
Any possible side effects
Timepoint
End of study
Method of measurement
Registration by the patient and questions from the patient
Intervention groups
1
Description
Intervention group: The drug group will receive 500 mg capsules containing Elaeagnus angustifolia flower extract powder for two months.
Category
Treatment - Drugs
2
Description
Control group: The placebo group will receive 500 mg capsules containing starch for two months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Hoda Kamali
Street address
Shafa Medical Education Research Center, Kausar Blvd.
City
Kerman
Province
Kerman
Postal code
Phone
+98 34 3211 5780
Email
hoda_3303@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpoor
Street address
Research and Technology Office, at the beginning of Ibn Sina Street, Samiya Crossroads (Tahmasababad)
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
iranpourabedin89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice President of Research and Technology of Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mohadese Kamali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian medicine, University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6000
Email
mohadesekamali0912@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohadese Kamali
Position
Assistant professorاستادیار
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian medicine, University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6000
Email
mohadesekamali0912@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohadese Kamali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian medicine, University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6000
Email
mohadesekamali0912@gmail.com
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