Protocol summary

Summary
The current research aims to examine the effect of rose essence on the improvement of sexual dysfunction caused by methadone administration and increase of happiness in the women treated with methadone. The research is a double blind clinical trial. The research’s statistical population is composed of all the women drug addicts referring to the addiction treatment center and Kermanshah Farabi Hospital, which 60 of them will be selected by an accessible method, and categorized into two groups of the control and experiment. The subjects of the experimental and control groups will be matched in terms of age, and the FSFI sexual dysfunction and happiness questionnaires will be distributed among them. In the experimental group, the participants will receive daily a capsule of rose essence a day, while the control group will receive a placebo capsule daily. The questionnaire will be re-distributed among both groups at the first, 4 weeks later, and at the end of the study (8 weeks after the start of the study), and the amount of happiness and amount of sexual function and happiness will be measured among them. In addition, at the beginning and end of the study, the blood sample will be sent to the laboratory in order to determine the level of the hormones, and the level of the hormones will be measured. Inclusion criteria: patients undergoing methadone treatment; minimum elementary education; married; age between 20-48 years; lack of sexual problems before treatment with methadone. Exclusion criteria: allergy to products made from rose essence; history of any endocrine disease such as elevated prolactine, thyroid disorders, and change in sexual activity because of pregnancy of wife, remarriage, and divorce.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091523705N2
Registration date: 2015-10-30, 1394/08/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Mostafa Alikhani
Name of organization / entity
Kermanshah University of Medical Sciences - Substance Abuse Prevention Research Center
Country
Iran (Islamic Republic of)
Phone
+98 838264513
Email address
mo.alikhani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Rose essence on improving sexual dysfunction and increase happiness in women treated with methadone
Public title
Effect of Rose Essence on women's sexual dysfunction and happiness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing methadone treatment; minimum elementary education; married; age between 20-48 years; lack of sexual problems before treatment with methadone. Exclusion criteria: allergy to products made from rose essence; history of any endocrine disease such as elevated prolactine, thyroid disorders, and change in sexual activity because of pregnancy of wife, remarriage, and divorce.
Age
From 20 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-08-18, 1394/05/27
Ethics committee reference number
kums.rec.1394.57

Health conditions studied

1

Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
Sexual dysfunction
Timepoint
The beginning of the study (baseline), week four and end of the study (week eight)
Method of measurement
Based on sexual function questionnaire (FSFI )

2

Description
happiness
Timepoint
The beginning of the study (baseline), week four and end of the study (week eight)
Method of measurement
Based on happiness questionnaire

3

Description
level of the hormone
Timepoint
Beginning and end of the study (week eight)
Method of measurement
By Blood Test

Secondary outcomes

empty

Intervention groups

1

Description
The control group will receive a placebo capsule daily.
Category
Placebo

2

Description
In the experimental group, the participants will receive daily one capsule of rose essence
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital-Addiction recovery center of Kermanshah city
Full name of responsible person
Mostafa Alikhani
Street address
Farabi hospital,Isar Blvd
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Psychiatrist
Other areas of specialty/work
Street address
Isar square, Farabi Hospital
City
Kermanshah
Postal code
Phone
0083309125188875
Fax
Email
vfarnia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Faezh Tatari
Position
Psychiatrist
Other areas of specialty/work
Street address
Isar square, Farabi Hospital
City
Kermanshah
Postal code
Phone
008338276683
Fax
Email
fztatari37@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Other areas of specialty/work
Street address
City
Kermanshah
Postal code
Phone
+98 83 3826 4513
Fax
Email
Vfarnia@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...