Determining the effect of Vitagnus drops on sexual function of women aged 50-70 years old referring to the retired center of North Khorasan province
Design
Clinical practice is a control group with no parallel groups, two blinds. Using the lottery, the intervention group and the placebo are identified. The sample size is 64. phase II clinical trial.
Settings and conduct
North Khorasan Retirees Association
Participants/Inclusion and exclusion criteria
1- 50-70 year-old women
2-No known psychological illness
3-Lack of emotional stress in the past six months (such as the death of close relatives)
4- In spite of being a spouse and living together with a spouse
5- Absent susceptibility to spices and essential oils
6- Lack of alcohol
7- Not using relaxation methods, hormonal, herbal and nerve drugs
8- Non-participation in similar researcا
9- Absence of a variety of cancers at the time of research
10- Failure to have breast and genital cancer in the past (endometrium, cervix, ovary)
11- Not getting bleeding or spotting
12- Absence of sexually transmitted malformations
• 1. Do not use drop for one week
• 2. People whose sexual performance is above 23
• 3- Observe spotting or bleeding during research
• 4. Use of estrogenic hormone or other herbal drugs of phytoestrogens affect the hormonal status during the research period.
• 5. Occurrence of adverse event during research
• 6. Sensitization
Intervention groups
The research unit is recommended to use 40 drops of vitagnus or placebo with a cold drink for 2 months at the beginning of the morning. The research unit is trained every two weeks, and at the time of being in the center, the amount of drops to be given until the next visit is required. Also, at the intervals of four, six and eight weeks from the onset of intervention, the sexual function questionnaire for the research unit is completed.
Main outcome variables
Sexual function
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20190528043736N1
Registration date:2019-06-12, 1398/03/22
Registration timing:registered_while_recruiting
Last update:2019-06-12, 1398/03/22
Update count:0
Registration date
2019-06-12, 1398/03/22
Registrant information
Name
Robabeh Amini ghalandar abad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3621 6366
Email address
r.amini.gh1363@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitagnus on sexual function of Women 50 to 70 years old Referring to the Retirement center of North Khorasan province
Public title
effect of vitagnus on sexual function of Women 50 to 70 years old
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
50-70 year-old women
No known psychological illness
Lack of emotional stress in the past six months (such as the death of close relatives)
In spite of being a spouse and living together with a spouse
Absent susceptibility to spices and essential oils
Lack of alcohol
Not using relaxation methods
Non-use of hormonal, herbal and nerve drugs
Non-participation in similar research
Absence of a variety of cancers at the time of research
Failure to have breast and genital cancer in the past (endometrium, cervix, ovary)
Not getting bleeding or spotting
Absence of sexually transmitted malformations
Exclusion criteria:
Do not use drop for one week
People whose sexual performance is above 23
Observe spotting or bleeding during research
Use of estrogenic hormone or other herbal drugs of phytoestrogens affect the hormonal
Occurrence of adverse event during research
Sensitization
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Those who have the conditions for entry into the study are given the necessary explanations for the study. A written consent form is signed by the patient and his wife and this way, people enter the study. At first, a demographic and clinical data form is made by the researcher and sexual function of women is completed in the interview. Then, people are classified according to age in four groups: 55-50, 60-55, 65-60 and 65-70 years old. Individuals are assigned code, and the groups are separated and separated by each other, using the lottery of the intervention group and the placebo. People in both groups are homogeneous in terms of age.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the negotiation and conclusion of the contract with the pharmaceutical company Poursina Drosa Vitagnus, along with placebo, the company will supply the research unit. Both the vials and the placebo drops contain the same visual appearance, and will be inscribed only on the glass of the letters A and B.
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.NKUMS.REC.1398.007
Street address
No14, Khoram Ave, Molla Sadra Blvd, Bojnourd town
City
bojnourd
Province
North Khorasan
Postal code
9415917533
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.NKUMS.REC.1398.007
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52.8
ICD-10 code description
Other sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
sexual function
Timepoint
Comparison of the total sexual function of the units before, 4 weeks, 6 weeks, and 8 weeks after taking Vitagnus drops
Method of measurement
Comparison of sexual function before and after taking Vitagnus drops is measured by Rosen's Sexual Function Questionnaire.
Secondary outcomes
1
Description
Menopause symptoms
Timepoint
At the beginning of the study (before the study) 4 weeks, 6 weeks, 8 weeks
Method of measurement
Demographics and clinical demographic data form
Intervention groups
1
Description
"Intervention group": Intervention group: It is recommended to the research unit that at the beginning of the morning, use 40 drops of vitagnus with a cold drink for 2 months in the morning. The research unit is trained every two weeks and at the time of being in the center, the amount of drops consumed before the next visit is required and thus, people in terms of how the drops are consumed and how much they are consumed By handing the empty glass to the researcher, the drug is examined. Also, at the intervals of four, six and eight weeks from the onset of intervention, the sexual function questionnaire for the research unit is completed.
Category
Treatment - Drugs
2
Description
"Control group": It is recommended to the research unit that at the beginning of the morning, use placebo with a cold drink for 2 months in the morning. The research unit is trained every two weeks and at the time of being in the center, the amount of drops consumed before the next visit is required and thus, people in terms of how the drops are consumed and how much they are consumed By handing the empty glass to the researcher, the drug is examined. Also, at the intervals of four, six and eight weeks from the onset of intervention, the sexual function questionnaire for the research unit is completed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
North Khorasan Retirees Association
Full name of responsible person
Zohre Abasi
Street address
No14, Khoram Ave, Molla Sadra Blvd, Bojnourd Town
City
Bojnourd
Province
North Khorasan
Postal code
9415917533
Phone
+98 58 3621 6366
Email
r.amini.gh1363@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Assistant Professor of North Khorasan University of Medical Sciences
Full name of responsible person
Seyd Kaveh Hojjat
Street address
Shahriar Ave. from Imam Ali Hospital, Faculty of Medical Sciences, Bojnourd Town
City
Bojnourd
Province
North Khorasan
Postal code
9415917533
Phone
+98 58 3229 7182
Fax
Email
S.Kavehhojjat@gmail.com
Web page address
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Assistant Professor of North Khorasan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Zohre Abasi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
N14,Khoram Ave, Molla Sadra Blvd
City
Bojnourd
Province
North Khorasan
Postal code
9415917533
Phone
+98 58 3621 6366
Email
r.amini.gh1363@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Zohre Abasi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
N14,Khoram Ave, Molla Sadra Blvd
City
Bojnourd
Province
North Khorasan
Postal code
9415917533
Phone
+98 58 3621 6366
Email
r.amini.gh1363@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Zohre Abasi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
N14,Khoram Ave, Molla Sadra Blvd
City
Bojnourd
Province
North Khorasan
Postal code
9415917533
Phone
+98 58 3621 6366
Email
r.amini.gh1363@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available