Objective: the effect of Product of Melissa officinalis on improvement Female sexual desire. Design:This study is a randomized double-blind placebo-controlled. Blindness has been done for Groups of patients and researchers. Inclusion criteria: women aged 18-50 years diagnosed with low sexual desire to have emotionally satisfying relationship with constant wife sexually active. Exclusion criteria: Impaired emotionally satisfying relationship with wife. Target sample size: 38. Intervention: capsule contained 500 mg lemon balm extract. Intervention time: 2 times a day, every time 2 capsules after breakfast, dinner used for 4 weeks. Primary outcome: sexual desire
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014021516580N1
Registration date:2014-06-27, 1393/04/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
Registrant information
Name
Zahra Darvish Mofrad Kashani
Name of organization / entity
Shahed
Country
Iran (Islamic Republic of)
Phone
+98 21 2247 3019
Email address
z.kashani@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahed University of Medical Sciences
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2015-10-25, 1394/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of Product of Melissa officinalis on improvement of 18-50 years old Female sexual desire
Public title
The effect of Melissa officinalis on Female sexual desire
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Women ages 18-50 years; Diagnosis low sexual desire by using the FSFI ( Female Sexual Function Index ); Emotionally satisfying relationship with constant wife sexually active at least one year; Having sex at least once a month; Lack of pregnancy and lactation; No menstruation retard for 2 months and more ; Normal genital examination. Exclusion criteria : Impaired emotionally satisfying relationship with wife ; Adding another partner in the study period; Any organic disease, anatomical and hormonal that exist in history and past medical history, including : diabetes , cerebrovascular disease , liver and kidney damage , heart disease , hypothyroidism, cancer; Psychiatric disorders who are under medical treatment; Smoking , alcohol , drug abuse; Use of any chemical and herbal medications that affect sexual desire.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee for Medical Research Ethics shahed university
Street address
Opposite of Imam Khomeiny Shrine
City
Tehran
Postal code
Approval date
2014-03-03, 1392/12/12
Ethics committee reference number
195148/41
Health conditions studied
1
Description of health condition studied
female sexual dysfunction
ICD-10 code
F52.0
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual desire
Timepoint
Baseline, 4 and 8 weeks after starting the medication
Method of measurement
Questionnaire Female Sexual Function Index
Secondary outcomes
1
Description
Sexual arousal
Timepoint
Baseline, 4 and 8 weeks after starting the medication
Method of measurement
Questionnaire Female Sexual Function Index
2
Description
Sexual Satisfaction
Timepoint
Baseline, 4 and 8 weeks after starting the medication
Method of measurement
Questionnaire Female Sexual Function Index
3
Description
Obvious distress caused by sexual dysfunction
Timepoint
Baseline, 4 and 8 weeks after starting the medication
Method of measurement
Question of patients
4
Description
Painful intercourse.
Timepoint
Baseline, 4 and 8 weeks after starting the medication
Method of measurement
Questionnaire Female Sexual Function Index
5
Description
Moisture of genitalia
Timepoint
Baseline, 4 and 8 weeks after starting the medication
Method of measurement
Questionnaire Female Sexual Function Index
6
Description
Increased frequency of sexual intercourse.
Timepoint
Baseline, 4 and 8 weeks after starting the medication
Method of measurement
Question of patients
Intervention groups
1
Description
Intervention group, capsule contained 500 mg lemon balm extract, 2 times a day, every time 2 capsules after breakfast, dinner used for 4 weeks.
Category
Treatment - Drugs
2
Description
Control group, capsule contained 500 mg starch , 2 times a day, every time 2 capsules after breakfast, dinner used for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa Khomeiny hospital
Full name of responsible person
Zahra Darvish Mofrad Kashani
Street address
Italia
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahed University of Medical Sciences
Full name of responsible person
Elham Emaratkar
Street address
Opposite of Imam Khomeiny shrine
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shahed University of Medical Sciences
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
Shahed University of Medical Sciences
Full name of responsible person
Zahra Darvish Mofrad Kashani
Position
PhD student
Other areas of specialty/work
Street address
Opposite of Imam Khomeiny shrine
City
Tehran
Postal code
Phone
+98 21 5567 8943
Fax
Email
z.kashani@shahed.ac.ir; zahrakashani14@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Nafiseh Zafarghandi
Position
Board gynecologic surgery
Other areas of specialty/work
Street address
Abdollahzade Street
City
Tehran
Postal code
1451635111
Phone
+98 21 8896 3849
Fax
Email
nafis_zafar@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University of Medical Sciences
Full name of responsible person
Zahra Darvish Mofrad Kashani
Position
PhD student
Other areas of specialty/work
Street address
Opposite of Imam Khomeiny shrine
City
Tehran
Postal code
Phone
+98 21 5567 8934
Fax
Email
z.kashani@shahed.ac.ir; zahrakashani14@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)