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Comparison of Rose Essence and placebo in improving sexual disorders and increase of happiness in men treated with methadone

Protocol summary

Summary
This study will be done to compare the impact of Rose Essence and placebo in improving sexual dysfunction , caused by methadone and increase of happiness in men treated with methadone . The research is a double blind clinical trial. The study sample population is consist of all male drug addicts referring to the addiction treatment center of Farabi Hospital in Kermanshah, which 60 of them will be selected by convenience method, and will be categorized into control and experiment. The subjects of both groups will be matched in terms of age, and the erectile function and happiness questionnaires will be distributed among them. In the experimental group, the participants will receive a capsule of rose essence daily , 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 happiness and sexual function will be measured . 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.. Inclusion criteria: patients under methadone treatment; at least elementary education;be married; age between 20-48 years; have not sexual problems before treatment with methadone; no history of any glands disease, such as elevated prolactin and thyroid disorder. Exclusion criteria: allergy to products made from rose essence; changes in sexual activity because of (wife pregnancy, remarried, divorce).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091523705N1
Registration date: 2015-12-15, 1394/09/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-15, 1394/09/24
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
2015-09-18, 1394/06/27
Expected recruitment end date
2015-11-18, 1394/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Comparison of Rose Essence and placebo in improving sexual disorders and increase of happiness in men treated with methadone
Public title
Effect of Rose Essence on sexual dysfunction and happiness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients under methadone treatment; elementary education or higher; married; age between 20-48 years; have not sexual problems before treatment with methadone; no history of any glands disease, such as elevated prolactin and thyroid disorder. Exclusion criteria: allergy to products made from rose essence; changes in sexual activity because of (wife pregnancy, remarried, divorce).
Age
From 20 years old to 48 years old
Gender
Male
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
Randomization will be done by coin toss and patients will be assigned to either control or experimental group. In both groups, patients and the facilitator do not know which group will receive Rose Essence and which group will receive placebo. So, it is a double-blind clinical trial.

Secondary Ids

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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.1394.58

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 (IIEF)

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(OHI)

3

Description
level of the Thyroid hormone
Timepoint
Beginning and end of the study (week eight)
Method of measurement
By experimental Kit

4

Description
Sexual hormones level
Timepoint
The baseline and end of the study(Eighth week)
Method of measurement
By experimental Kit

Secondary outcomes

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Intervention groups

1

Description
In the experimental group, the participants will receive a capsule of rose essence daily ,then the questionnaire will be re-distributed at the baseline, 4 weeks later, and at the end of the study (8 weeks after the start of the study), and the happiness and sexual function will be measured. 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 T4, T3, Thyroid, and Testosterone, and the level of the hormones will be measured.
Category
Treatment - Drugs

2

Description
In the control group participant will receive a placebo capsule daily. then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), and the happiness and sexual function will be measured. 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 T4, T3, Thyroid, and Testosterone, and the level of the hormones will be measured.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital-Addiction recovery center
Full name of responsible person
Street address
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
+98 83 3826 4513
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.Jalal Shakeri
Position
Psychiatrist
Other areas of specialty/work
Street address
Isar square, Farabi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3827 6683
Fax
Email
Jshakeri@kums.ac.ir
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
Psychiatrist
Other areas of specialty/work
Street address
Isar square, Farabi Hospital
City
Kermanshah
Postal code
Phone
008338264513
Fax
Email
Vfarnia@yahoo.com
Web page address

Sharing plan

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