Protocol summary
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Study aim
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Comparison of the effectiveness of the topical preparation of Ghost( Costus Amorous ) oil with placebo in improving the libido of postmenopausal women
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomization of ten, phase 2 on 100 patients,
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Settings and conduct
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The context of this study is to investigate the effect of Ghost oil medicinal product on the sexual desire of postmenopausal women. The place of research: Behesht Salamat, Hazrat Rasool Hospital. The packaging of the drugs in the intervention and control groups is the same, and the patients and the person who examines the symptoms can be blinded.
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Participants/Inclusion and exclusion criteria
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Entry conditions: Menopause 65-40 years more than 1 year with libido, FSFI <=26 , MSR<=5, emotionally satisfying relationship with stable spouse and sexual activity for at least 6 months. Normal pelvic exam, a wife who spends at least half a month with the family, filling out the consent form ;
non-entry: vaginal infection, vaginal bleeding, serious physical and chronic disease requiring constant care, use of chemical and herbal drug, use of libido drug , use of substance abuse, to the use of any chemical drug satisfactory
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Intervention groups
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Intervention group: Tuba company's Ghost (Costus Amorous )oil twice a day and each time 20 drops on the pubic area with back and forth massage for 5 minutes and 2 drops on the perineum area and circular massage for 1 minute, four weeks.
Control group: liquid paraffin manufactured by Merk Co twice a day and each time 20 drops on the pubic area in a back-and-forth massage for 5 minutes and 2 drops will be massaged on the perineum for 1 minute , four weeks
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Main outcome variables
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Sexual desire
General information
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Reason for update
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Changes in Sample size and secondary outcomes
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230730058969N1
Registration date:
2023-10-15, 1402/07/23
Registration timing:
registered_while_recruiting
Last update:
2024-04-25, 1403/02/06
Update count:
1
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Registration date
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2023-10-15, 1402/07/23
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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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2023-09-23, 1402/07/01
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Expected recruitment end date
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2024-09-22, 1403/07/01
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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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Investigating the effect of topical oil preparation of Ghost (Costus Amorous ) on the reduction of sexual desire in postmenopausal women compared to placebo: a double-blind randomized clinical trial
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Public title
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Investigating the topical effect of Ghost ( Costus Amorous) oil on the reduction of sexual desire in postmenopausal women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Postmenopausal women between the ages of 40 and 65, who have been for a year since their last period, and complain of decreased sexual desire
Completing the FSFI questionnaire and assessing the loss of sexual desire based on it, including a number equal to or less than 26
Menopause symptoms are not severe (less than 5), the score of the MSR questionnaire (menopause symptom severity) is 1 to 5
Having an emotionally satisfying relationship with a stable and sexually active spouse for at least the last 6 months
Normal pelvic examination
Having a wife who spends at least half of a month with the family
At least 6 months have passed since the beginning of cohabitation
Signing consent to participate in the project
Exclusion criteria:
Vaginal infection
Vaginal bleeding
The presence of a serious physical medical condition and a chronic illness that requires constant care
Taking any chemical and herbal medicine known to affect libido
Smoking and any substance abuse
Disruption of a satisfactory emotional relationship with the spouse during the study
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Age
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From 40 years old to 65 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
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Sample size
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Target sample size:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation to intervention groups and description of randomization: In this study, we used the block randomization method, and in this two-group clinical trial, there were blocks of 4 samples. For each person who enters the study, a code is obtained and it is determined which group (intervention or control) they belong to. For randomization, the "Random allocation software" is used which is downloadable freely from:https://random-allocation-software.software.informer.com/2.0/. In this software, 2 groups and 100 sample sizes, block method with random block size are selected, then the output is a random list.
In order to hide, we use specialized random Allocation concealment, this method is such that before assigning the person, the allocated group is not known, in this way, by using non-transparent envelopes sealed with a random sequence, which In this method, each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same order. Finally, the cover of the envelopes is glued and placed in a box in order.Blocking and preparation of envelopes is done by a person not involved in sampling and data analysis, in this way the collector and the analyst and the participant receive the type of intervention and that every What group is the person in? It is not known.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The drug and placebo are prepared with the same color, consistency, and smell and are packaged and labeled in the same containers.
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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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2023-07-31, 1402/05/09
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Ethics committee reference number
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IR.IUMS.REC.1402.378
Health conditions studied
1
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Description of health condition studied
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Hypoactive sexual desire disorder
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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 desire
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Timepoint
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At first, 2 week, 4week
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Method of measurement
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FSFI questionnaire
Secondary outcomes
1
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Description
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Sexual arousal levels
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Timepoint
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At first, 2week, 4week
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Method of measurement
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FSFI questionnaire
2
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Description
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Vaginal lubrication levels
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Timepoint
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At first, 2 week ,4 week
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Method of measurement
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FSFI questionnaire
3
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Description
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Orgasm levels
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Timepoint
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At first, 2week ,4week
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Method of measurement
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FSFI questionnaire
4
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Description
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Satisfaction sexual levels
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Timepoint
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At first, 2week, 4week
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Method of measurement
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FSFI questionnaire
5
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Description
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Disparonia levels
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Timepoint
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At first, 2week, 4week
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Method of measurement
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FSFI questionnaire
6
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Description
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Sexual function
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Timepoint
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At first, 2week, 4week
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Method of measurement
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FSFI questionnaire
7
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Description
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Side effects of drugs
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Timepoint
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2week and 4 week
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Method of measurement
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Medication side effects questionnaire
8
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Description
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BoBody temperament
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Timepoint
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At first and the end of study( after 4 weeks)
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Method of measurement
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Body temperament questionnaire
9
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Description
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Severity of menopause symptom
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Timepoint
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At first and the end of study
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Method of measurement
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MSR questionnaire
10
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Description
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Severity of menopause
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Timepoint
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At first and end of study
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Method of measurement
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Menopause Rating Scale (MRS)
Intervention groups
1
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Description
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Intervention group: receiving Tubi's Ghost oil product and apply topically twice a day and each time 20 drops on the pubic area in a back and forth massage for 5 minutes (superficial and without pressure) and 3 drops on the perineum area for 1 minute in a circular massage. The duration of the study is four weeks .
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Category
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Treatment - Drugs
2
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Description
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Control group: paraffin oil from Merck company and apply topically twice a day and each time 20 drops on the pubic area in a back and forth motion for 5 minutes massage (superficial and without pressure) and 3 drops on the perineum area for 1 minute in a circular motion. He will give a massage. The duration of the study is four 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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Institute of Medical History, Islamic and Complementary Medicine Studies
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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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available