Protocol summary
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Study aim
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Determination of the Effect of Vitex plant on the score of sexual function in Women Referring to Alzahra Health Center in Rasht
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Design
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Clinical trials with control group, with parallel groups, double blind, randomized
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Settings and conduct
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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, 12 and 16 weeks after the intervention using the Women sexual function Index.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Administration of Agnugol tablet containing 2.3-4.8 mg of vitex plant; at first, 4, 8,12 and 16 weeks in intervention group
Administration of placebo tablet containing starch 2.3-4.8 mg; at first, 4, 8, 12 and 16 weeks in control group
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Main outcome variables
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Sexual function
General information
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Reason for update
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publication of results in two parts
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100503003860N36
Registration date:
2018-12-09, 1397/09/18
Registration timing:
prospective
Last update:
2021-01-27, 1399/11/08
Update count:
2
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Registration date
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2018-12-09, 1397/09/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-22, 1397/10/01
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Expected recruitment end date
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2020-05-19, 1399/02/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Vitex Plant on Female Sexual Function
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Public title
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Effect of Vitex Plant on Female Sexual Function
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 15 years old to 44 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
102
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-05, 1397/08/14
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1397.155
Health conditions studied
1
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Description of health condition studied
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Sexual dysfunction
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ICD-10 code
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F52.0
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ICD-10 code description
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Hypoactive sexual desire disorder
Primary outcomes
1
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Description
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Sexual function
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Timepoint
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Before the intervention, 4,812 and 16 weeks after the intervention
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Method of measurement
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Female Sexual Function Index questionnaire
Secondary outcomes
1
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Description
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Sexual desire score
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Timepoint
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Before the intervention, 4, 8,12 and 16 weeks after the intervention
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Method of measurement
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Female Sexual Function Index questionnaire
2
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Description
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Sexual Arousal Score
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Timepoint
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Before the intervention, 4, 8,12 and 16 weeks after the intervention
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Method of measurement
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Female Sexual Function Index questionnaire
3
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Description
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Orgasm Score
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Timepoint
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Before the intervention, 4, 8,12 and 16 weeks after the intervention
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Method of measurement
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Female Sexual Function Index questionnaire
4
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Description
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Coitus of Pain Score
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Timepoint
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Before the intervention, 4, 8,12 and 16 weeks after the intervention
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Method of measurement
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Female Sexual Function Index questionnaire
5
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Description
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Sexual Satisfaction Score
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Timepoint
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Before the intervention, 4, 8,12 and 16 weeks after the intervention
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Method of measurement
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Female Sexual Function Index questionnaire
Intervention groups
1
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Description
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Intervention group: Administration of Agnugol tablet containing 2.3-4.8 mg of vitex plant; manufactured by Gol Dara Co.; Iran; at 0, 4, 8,12 and 16 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Administration of placebo tablet containing starch 2.3-4.8 mg; manufactured by Shahid Beheshti Pharmaceutical Faculty; Tehran; Iran; at 0, 4, 8,12 and 16 weeks
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Thereport plan is still unknown
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available