1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Effectiveness of food production and sexual behavior education in improving women's sexual of reproductive age according to Iranian traditional medicine.
Protocol summary
Summary
Objective: Effectiveness of food production and sexual behavior education in improving women's sexual of reproductive age according to Iranian traditional medicine. Design: A double blinded, block randomized clinical trial. Study population: Women of reproductive age with sexual function. Inclusion criteria: Aged between 18 and 35 years; having partner at least 21 days per month; no pregnancy and breastfeeding; not having chronic disease; normal clinical breast
examination; no husband's sexual problems; no addiction and alcoholism; having sexual dysfunction more than 6 month. Exclusive criteria: Decision to divorce;
pregnancy; having chronic disease; using affecting sexual function drugs; drug side effects; severe Hemodynamic disorders. Sample size: 96 cases. Study intervention: The control group are revising appropriate sexual behavior education according to Iranian
traditional medicine, intervention group one are treatment with 15g traditional medicine’s food product twice per day, intervention group two are treatment with 15g traditional medicine’s food product twice per day and appropriate sexual behavior education according to Iranian traditional medicine for two months. Study outcome: Evaluation and comparison of women’s sexual function for measuring desire, sexual arousal, lubrication, orgasm and pain, and satisfaction of sexual function based on FSFI questionnaire at before intervention, four weeks and two months after intervention in groups.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2015122425681N1 Registration date: 2016-05-27, 1395/03/07 Registration timing: prospective
Last update:
Update count: 0 Registration date
2016-05-27, 1395/03/07 Registrant information
Name
Tahereh Molkara
Name of organization / entity Mashad university medical science Country
Iran (Islamic Republic of) Phone
+98 51 3855 2188 Email address
molkarat2@mums.ac.ir Recruitment status
Recruitment complete Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date 2016-06-21, 1395/04/01
Expected recruitment end date 2016-10-22, 1395/08/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Effectiveness of food production and sexual behavior education in improving women's sexual of reproductive age according to Iranian traditional medicine.
Public title
2 Effectiveness of sexual behavior education in improving
women's sexual according to Iranian traditional medicine.
Purpose Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 18 and 35; having partner at least 21 days per month; no pregnancy and breastfeeding; not having chronic disease; normal clinical breast examination; no husband's sexual problems; no addiction and alcoholism; having sexual dysfunction more than 6 month. Exclusive criteria:
Decision to divorce; pregnancy; having chronic disease;
using affecting sexual function drugs; drug side effects;
severe Hemodynamic disorders.
Age
From 18 years old to 35 years old Gender
Female Phase
2
Groups that have been masked No information
Sample size
Target sample size: 96
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Double blinded Blinding description Placebo
Not used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City Mashhad Postal code
13944-91388 Approval date
2016-05-07, 1395/02/18
Ethics committee reference number IR.MUMS.REC.1395.65
Health conditions studied
1
Description of health condition studied Sexual function
ICD-10 code F52.8
ICD-10 code description
Other sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description Sexual function Timepoint
Before intervention, four weeks and two months after intervention
Method of measurement FSFI questionnaire
Secondary outcomes
1
Description
Sexual desire and arousal Timepoint
Before intervention, four weeks and two months after intervention
Method of measurement FSFI questionnaire
Intervention groups
1
Description
Control group: who are revising appropriate sexual behavior education according to Iranian traditional medicine for two months.
Category Behavior
2
Description
Intervention group 1: who are treatments with 15g traditional medicine’s food product twice per day for two months.
Category Behavior
3
Description
Intervention group 2: who are treatments with 15g traditional medicine’s food product twice per day and appropriate sexual behavior education according to
3 Iranian traditional medicine for two months.
Category Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Iranian Traditional Medicine and Complementary of Mashhad University of Medical Sciences
Full name of responsible person Malihe Motavasselian
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran Sports Hall, East Razi Ave.
City Mashhad
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City Mashhad 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, Mashhad 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
Mashhad University of Medical Sciences Full name of responsible person
Tahereh molkara Position
PhD Student of Traditional Medicine Other areas of specialty/work Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran Sports Hall, East Razi Ave.
City Mashhad Postal code
13944-91388 Phone
+98 51 3841 1538 Fax
molkarat2@mums.ac.ir dr.nmolkara1352@yahoo.com Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences Full name of responsible person
Malihe Motavasselian Position
Assistant Professor
Other areas of specialty/work Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran Sports Hall, East Razi Ave.
City Mashhad Postal code Phone
+98 51 3855 2188 Fax
motavasselianm@mums.ac.ir Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences Full name of responsible person
Tahereh Molkara Position
phD student of Iranian Traditional Medicine Other areas of specialty/work
Street address
Faculty of Iranian Traditional Medicine and Complementary, Opposite the Mehran Sports Hall, East Razi Ave
City Mashhad
4 Postal code
9135913556 Phone
+51 38552188 Fax
+98 51 3853 5980 Email
molkarat2@mums.ac.ir Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
empty Study Protocol
empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
