Comparison between the effect of sexual health education, Celery seed capsule and combine therapy on married women 18-44 years old with Sexual Dysfunction.
The present clinical, randomized, placebo controlled trial aimed to determine the effect of sexual health education , Celery seed capsule and combine therapy on married women with Sexual Dysfunction. the study population included the married women from 18 to 44 years old attending the selected gyneocology clinics of Shiraz university of medical sciences which had agreed to cooperate with the researchers. In case the study subject sufferd from any ilness, were not willing to continue participating in the study, and showed allergic reactions to medication, they were excluded from the study. After all, a total of 160 subjects were entered into the study and randomly divided into 4 groups receiving the drug, training, and placebo, respectively for 6 weeks. sexual function was evaluated with using FSFI questionnaire. index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012112411032N3
Registration date:2012-12-04, 1391/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-04, 1391/09/14
Registrant information
Name
Tahereh Rahnavard
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 71164742528
Email address
rahnavardt@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research office of Shiraz University Of Medical Sciences
Expected recruitment start date
2012-10-02, 1391/07/11
Expected recruitment end date
2013-01-30, 1391/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of sexual health education, Celery seed capsule and combine therapy on married women 18-44 years old with Sexual Dysfunction.
Public title
Evaluation of the effect of herbal medicine and education on sexual dysfunction in married women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:willingness to participate; married woman with age between 18-44 years old; Not taking any medications that affect sexual function such as OCP; antidepressant; antihistamine; SRII ; anti hypertensive drug and herbal drug such as Yohimbe; Ginseng; Viramax; Afrodit;. Not having disease such as heart disease; hyperthyroidism; hypothyroidism; renal infection; diabetic; epilepsy; Arthritis. Not pregnant; not lactation; not familial disorder; not psychotic problem; no addiction; not psychotic consultation. Exclusion criteria: unwillingness to cooperate after the beginning of the study, and showing allergic reaction to herbal drug.
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Shiraz University Of Medical Sciences
Street address
Central department of Shiraz University Of Medical Sciences,Zand Street, Shiraz
City
Shiraz
Postal code
7188833398
Approval date
2012-10-02, 1391/07/11
Ethics committee reference number
CT-91-6156
Health conditions studied
1
Description of health condition studied
female sexual dysfunction
ICD-10 code
F50, F51,
ICD-10 code description
Behavioural syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
female sexual dysfunction
Timepoint
At the start of intervention- After intervention
Method of measurement
Female Sexual Function Index Questionnaire
Secondary outcomes
1
Description
Dont have
Timepoint
During the study and after completion of it
Method of measurement
Female Sexual Function Index Questionnaire
Intervention groups
1
Description
Training of sexual health for 6 sessions of 45 minutes.
Category
Behavior
2
Description
placebo capsules are used 3 per day (one for each 8 hours ) for 6 weeks.
Category
Treatment - Drugs
3
Description
combine therapy include: Sexual health education and use of celery seed capsule
Category
Treatment - Other
4
Description
Intervention with celery seed capsules for each patient 1500 mg/day in 3 separated doses(each 8 hours one capsule) for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahhari Clinic
Full name of responsible person
Masumeh Kaviani
Street address
Namazi square
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Masumeh Kaviani
Street address
Zand street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
DR. Gholam Reza Hatam
Street address
7th Flat, Central department of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
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, Shiraz 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
Fatemeh College of Nursing And Midwifery,Shiraz University of Medical Sciences
Full name of responsible person
Masumeh Kaviani
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4252
Fax
Email
Kavianm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery Shiraz University of Medical Sciences
Full name of responsible person
Masumeh Kaviani
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4252
Fax
Email
Kavianm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery Shiraz University of Medical Sciences
Full name of responsible person
Tahereh Rahnavard
Position
Student, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4252
Fax
Email
rahnavardt@sums.ac.ir Rahnavard21@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)