The effect of oral Afrodit drop on sexual function and Menopause Rating Scale in menopausal women referred to selected health centers related to Tehran University of Medical Sciences
The objective of the study is to assess the effect of Afrodit oral Capsule on sexual function and Menopause Rating Scale in menopausal women referred to selected health centers affiliated to Tehran University of Medical Sciences. Major inclusion criteria includes: Not having physical and psychological diseases in women and their husbands, having at least one sexual contact during the intervention for 4 weeks and Exclusion criteria includes: Not having sex during the study, Taking any additional medication during the study, Not taking the drug under investigation for more than 4 days during the study.More than 250 volunteered menopausal women will be interviewed using sabastburg sexual function Questionnaire and Menopause Rating Scale. About 70 of those who have sexual dysfunction will be invited to participate in the study and fill in a written consent form. Subjects will be randomly divided into two 35 intervention and control groups. The intervention group will receive Afrodit Capsule, three times a day for 4 weeks and the control group will receive placebo, at the same dose. Sabasburg sexual function Index questionnaire score and will be measured and Menopause Rating Scale compared in the two groups before and 4 weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107122172N11
Registration date:2012-03-17, 1390/12/27
Registration timing:na
Last update:
Update count:0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Simin Taavoni
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 8161
Email address
staavoni@iums.ac.ir
Recruitment status
Not enough for processing
Funding source
Research Institute for Islamic & Complementary Medicine
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2012-06-01, 1391/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral Afrodit drop on sexual function and Menopause Rating Scale in menopausal women referred to selected health centers related to Tehran University of Medical Sciences
Public title
The effect of oral Afrodit Capsule on sexual function and Menopause Rating Scale in menopausal women referred to selected health centers related to Tehran University of Medical Sciences
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: At least 1 year past the menopause; have sex at least once during the 4 weeks; Not having known physical or mental illness; having physical and mental health in husband; Having a stable partner before and during intervention; No additional drugs during the study (including hormone therapy or any drugs that affect sexual function) Exclusion criteria: Not having sex during study; not use the Capsules to 4 days during the intervention
Exclusion criteria: Not having sex during study; not use the drops to 4 days during the intervention
Age
From 50 years old to 60 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute for Islamic & Complementary Medicine
Street address
No.9, Pirniya1, Ave-Northern Lalehzar, street Jomhoory eslami,Tehran
City
Tehran
Postal code
Approval date
2011-09-17, 1390/06/26
Ethics committee reference number
14537
Health conditions studied
1
Description of health condition studied
sexual disfunctions , menopause symptems, Symptoms of Menopause
ICD-10 code
F52.8, F52
ICD-10 code description
Other sexual dysfunction, not caused by organic disorder or disease,
Primary outcomes
1
Description
sexual function score
Timepoint
before intervention and one mount after intervention
Method of measurement
sanastburg sexual function questionnaire
2
Description
Added at 2013-04-27:Symptoms of Menopause Score
Timepoint
Added at 2013-04-27: before intervention and one mount after intervention
Method of measurement
Added at 2013-04-27: .Primary outcome method of measurement:Menopause Rating Scale(MRS
3
Description
Added at 2013-04-27:
Timepoint
Added at 2013-04-27:
Method of measurement
Added at 2013-04-27:
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group 60 oral Afrodit Capsule tree daily for4 weeks
Category
Treatment - Drugs
2
Description
In control group 60 placebo capsule tree daily for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeyni health center
Full name of responsible person
Eshtehardi, Shiva
Street address
Saat Square, Old Karaj Road, Ghods City
City
Ghods
2
Recruitment center
Name of recruitment center
Emam Hoseyn health center
Full name of responsible person
Eskandari, Zahrah
Street address
Shahid Alami street, Azadi Square, Old Karaj Road, Ghods City
City
Ghods
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Institute for Islamic & Complementary Medicine
Full name of responsible person
Dr. Ashrafedin Gooshegir
Street address
No.9, Pirniya1, Ave-Northern Lalehzar, street Jomhoory eslami,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic & Complementary Medicine
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty, tehran University of Medical Sciences
Full name of responsible person
simin Taavoni
Position
M.Sc in Medical Education, M.Sc in Midfwifery Education, Academic Faculty Member & Resaercher