Determination of the Effect of Vitex plant on the score of sexual function in Women Referring to Alzahra Health Center in Rasht
Design
Clinical trials with control group, with parallel groups, double blind, randomized
Settings and conduct
The subjects were women referring to the women's clinic of Al-Zahra Educational care Center, Rasht, which were selected according to inclusion criteria. After giving explanations to individuals, they are randomly divided. The intervention groups and the investigator do not know how to intervene. The method of intervention is to evaluate the performance of sexual function and its areas at the beginning of the study and 4, 8 and 12 weeks after the intervention using the Women sexual function Index.
Participants/Inclusion and exclusion criteria
All fertile women who referred for Pap smear and were healthy in gynecological and physical examinations and seeking treatment for the improvement and enhancement of sexual function
Intervention groups
Administration of Agnugol tablet containing 2.3-4.8 mg of vitex plant; at first, 4, 8 and 12 weeks in intervention group
Administration of placebo tablet containing starch 2.3-4.8 mg; at first, 4, 8 and 12 weeks in control group
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100503003860N36
Registration date:2018-12-09, 1397/09/18
Registration timing:prospective
Last update:2018-12-09, 1397/09/18
Update count:2
Registration date
2018-12-09, 1397/09/18
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitex Plant on Female Sexual Function
Public title
Effect of Vitex Plant on Female Sexual Function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fertile women 15-44 years who referred for Pap smear
Healthy in gynecological and physical examinations
Seeking treatment for the improvement and enhancement of sexual function
Exclusion criteria:
single
Pregnant and lactating
Illiterate / cannot read and write
Having a specific illness (thyroid problems, diabetes, psychiatric disorders, hyper-prolactonemia, liver problems, etc.)
Stressful event in the last 6 months (death or disease of immediate family member, a major change in lifestyle) of any of the couples
Mental problems (illness under the supervision or treatment of a physician) in each of the couples according to the woman's statement
Treated for any sexual problems in each of the couples according to the woman's statement
Alcohol or drug addiction in each of the couples according to the woman's statement
Women whose husbands are unable to have normal sex (e.g., erectile dysfunction or premature ejaculation)
Any illness in women, including abnormal bleeding, cervicitis and vaginitis without premenstrual tension and premenstrual syndrome.
Taking vitamin supplements or hormonal pills like contraceptives
Age
From 15 years old to 44 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description of each method: In the custody
In randomization unit: Individual
Randomization tool: Random number function, opaque and closed envelopes
How to create random sequence: Generate random number function in Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the allocation, the pills will be divided into the opaque A and B packets and numbered by the anonymous researcher in the sampling. Participant, clinical caregiver, researcher, and outcome evaluator of the type of intervention will be unaware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.155
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention, 4,8 and 12 weeks after the intervention
Method of measurement
Female Sexual Function Index questionnaire
Secondary outcomes
1
Description
Sexual desire score
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Female Sexual Function Index questionnaire
2
Description
Sexual Arousal Score
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Female Sexual Function Index questionnaire
3
Description
Orgasm Score
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Female Sexual Function Index questionnaire
4
Description
Coitus of Pain Score
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Female Sexual Function Index questionnaire
5
Description
Sexual Satisfaction Score
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Female Sexual Function Index questionnaire
Intervention groups
1
Description
Intervention group: Administration of Agnugol tablet containing 2.3-4.8 mg of vitex plant; manufactured by Gol Dara Co.; Iran; at 0, 4, 8 and 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Administration of placebo tablet containing starch 2.3-4.8 mg; manufactured by Shahid Beheshti Pharmaceutical Faculty; Tehran; Iran; at 0, 4, 8 and 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Educational care Center
Full name of responsible person
Farnoush Farzi
Street address
Al-Zahra Educational care Center., Namjoo Avenue., Rasht
City
Rasht
Province
Guilan
Postal code
41446-54839
Phone
+98 13 3336 9025
Email
azzahra@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
افشین زرقی
Street address
Nursing and Midwifery college of Shahid Beheshti University of Medical Sciences, in front of Shahid Rajaee Heart Hospital, Niayesh intersection, Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
gozgoli@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Giti ozgoli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Avenue, intersection of prayer facing Shahid Rajaee Heart Hospitaم
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
gozgoli@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Giti Ozgoli
Position
Assistant professor, PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Avenue, intersection of prayer facing Shahid Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Email
g.ozgoli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Giti ozgoli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Avenue, intersection of prayer facing Shahid Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
gozgoli@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Thereport plan is still unknown
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available