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Determination of the Effect of Vitex plant on the sexual satisfaction in Women

Protocol summary

Study aim
Determination of the Effect of Vitex plant on the sexual satisfication 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 satisfaction at the beginning of the study and 4, 8 and 12 weeks after the intervention using the Larson questioner.
Participants/Inclusion and exclusion criteria
Inclusion criteria include 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 satisfaction. Exclusion criteria include medication that interferes with sexual function
Intervention groups
The intervention group includes healthy women of reproductive age receiving Aknogol tablets for three months. The control group consists of healthy women of reproductive age receiving placebo tablets for three months.
Main outcome variables
sexual satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190703044086N1
Registration date: 2019-07-14, 1398/04/23
Registration timing: prospective

Last update: 2019-07-14, 1398/04/23
Update count: 0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Seyedeh Fatemeh Dalil Heirati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9224
Email address
fatemeh_heirati@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-10-14, 1399/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the Effect of Vitex plant on the sexual satisfaction in Women
Public title
Determination of the effect of Vitex plant on the sexual satisfaction in Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion 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 satisfaction
Exclusion criteria:
single, Pregnant and lactating, 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 25 years old to 44 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done individually by the random number function tool 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 Guilan University of Medical Sciences
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.GUMS.REC.1398.147

Health conditions studied

1

Description of health condition studied
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 Satisfaction
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Larson questionnaire

Secondary outcomes

1

Description
Medicinal effects
Timepoint
During and after medication
Method of measurement
Ask the patient

Intervention groups

1

Description
Intervention group: Administration of Agnugol tablet containing 2.3-4.8 mg of vitex plant;Manufacture of Gol Dara Co.; Iran; at first, 4, 8 and 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Administration of placebo tablet containing starch 2.3-4.8 mg; Construction of Shahid Beheshti Pharmaceutical Faculty, Tehran, Iran; at first, 4, 8 and 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Farnoush Farzi
Street address
Al-Zahra Hospital, Namjoo Ave
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3336 9224
Email
h_fertility@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
Candidate, MS of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Al-Zahra Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
dalilheirati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
Candidate, MS of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Al-Zahra Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
dalilheirati@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
Candidate MS of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Al-Zahra Hospital, Namjoo Ave.
City
Rasht
Province
Guilan
Postal code
54839 -41446
Phone
+98 13 3336 9224
Email
dalilheirati@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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