Protocol summary

Summary
The objective of this study is to assess effect of oral Royal jelly on menopausal symptoms and sexual function in 50-60 years old menopausal women referred to selected health centers related to Iran University of Medical Sciences 2013- 2014. In a triple- blind, placebo- controlled trial, 110 menopausal aged 50-60 years, will be recruited and fill "Sabbatsberg Sexual Rating Scale (SSRS), Menopause Rating Scale (MRS) and personal characteristics" questionnaire, and will sign an Informed Consent from. Inclusion criteria: Not having physical and psychological diseases in women and their spouses, having coitus at least twice in a month, Not using of sedative and hypnotic drugs, HRT and herbal medicines more than once a week, Not allergic to honey consumption and BMI less than 28 kg m . Exclusion criteria: Not having sexual activity during the study, not using the drug under investigation for more than 6 days in a month, using of any hormonal and herbal medication, using of Soy more than one meal per week, starting any vegetarian diet and allergic and not using of Antibiotics or Antacids during the study. The participants will be randomly divided in intervention and control groups (55 women in each group). The intervention group will receive Royal Jelly, 100 mg capsule, once daily for two months and the control group will receive placebo capsule, at the same dose as the intervention group. After two months, Sabbatsberg Sexual Rating Scale and Menopause Rating Scale Scores will be measured again, compared and analyzed in the two groups before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306022172N14
Registration date: 2013-06-12, 1392/03/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-06-12, 1392/03/22
Registrant information
Name
Simin Taavoni
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 8161
Email address
staavoni@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Institute for Islamic & Complementary Medicine
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral Royal jelly on menopausal symptoms and sexual function in 50-60 years old menopausal women
Public title
Effect of oral Royal jelly on menopausal symptoms and sexual function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Not having physical and psychological diseases in women and their spouses, having coitus at least twice in a month, Not using of sedative and hypnotic drugs, HRT and herbal medicines more than once a week, Not allergic to honey consumption and BMI less than 28 kg m . Exclusion criteria: Not having sexual activity during the study, not using the drug under investigation for more than 6 days in a month, using of any hormonal and herbal medication, using of Soy more than one meal per week, starting any vegetarian diet and allergic and not using of Antibiotics or Antacids during the study.
Age
From 50 years old to 60 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Institute for Islamic & Complementary Medicine
Street address
No.9, Pirniya1, Ave-Northern Lalehzar, street Jomhoory eslami,Tehran
City
Tehran
Postal code
Approval date
2013-05-29, 1392/03/08
Ethics committee reference number
122/ط م/26پ

Health conditions studied

1

Description of health condition studied
sexual disfunctions , menopause symptems, Symptoms of Menopause
ICD-10 code
F52.8, F52
ICD-10 code description
Other sexual dysfunction, not caused by organic disorder or disease,

Primary outcomes

1

Description
Menopausal symptoms score
Timepoint
End of first month of intervention
Method of measurement
Menopause Rating Scale (MRS) questionnaire

2

Description
Sexual function score
Timepoint
End of first month of intervention
Method of measurement
sabbastberg sexual function questionnaire

Secondary outcomes

1

Description
Sexual function score
Timepoint
End of first and second month of intervention
Method of measurement
sabbastberg sexual function questionnaire

2

Description
Menopausal symptoms score
Timepoint
End of first and second month of intervention
Method of measurement
Menopause Rating Scale (MRS) questionnaire

Intervention groups

1

Description
Intervention group: Royal Jelly Capsules, 100 Mg capsules once daily in tow month.
Category
Treatment - Other

2

Description
Control group: Placebo Capsules, 100 Mg capsules once daily in tow month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Abouzar Clinic
Full name of responsible person
Bahareh Lesani
Street address
Dastgheib Street, Ostad Moeen Street
City
Tehran

2

Recruitment center
Name of recruitment center
Fazel Haelth and Cure Center
Full name of responsible person
Dr Katyoon Seif Farahi
Street address
Water Street, Abdolahzadeh Street, Keshavarz Bulvard, Valiaasr Square
City
Tehran

3

Recruitment center
Name of recruitment center
Shahid Ghafari Haelth and Cure Center
Full name of responsible person
Dr Zahra Malayeri
Street address
Bazargolha, Phase 2, Ekbatan Parish
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Islamic & Complementary Medicine
Full name of responsible person
Dr. Ashrafedin Gooshegir
Street address
No.9, Pirniya1, Ave-Northern Lalehzar, street Jomhoory eslami,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Islamic & Complementary Medicine
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
Nursing and Midwifery Faculty, tehran University of Medical Sciences
Full name of responsible person
simin Taavoni
Position
PhD in Medical Education, M.Sc in Medical Education, M.Sc in Midfwifery Education, Academic Faculty
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St, Kazeroon St, Mirdamad Ave
City
tehran
Postal code
1919915375
Phone
+98 21 6692 1228
Fax
Email
staavoni14@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and Midwifery Faculty, tehran University of Medical Sciences
Full name of responsible person
simin Taavoni
Position
PhD in Medical Education, M.Sc in Medical Education, M.Sc in Midfwifery Education, Academic Faculty
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St, Kazeroon St, Mirdamad Ave
City
Tehran
Postal code
1919915375
Phone
+98 21 6692 1228
Fax
Email
staavoni14@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing and Midwifery Faculty, tehran University of Medical Sciences
Full name of responsible person
simin Taavoni
Position
PhD in Medical Education, M.Sc in Medical Education, M.Sc in Midfwifery Education, Academic Faculty
Other areas of specialty/work
Street address
3rd Floor, No.12, Nadjmabady St, Kazeroon St, Mirdamad Ave
City
Tehran
Postal code
1919915375
Phone
+98 21 6692 1228
Fax
Email
staavoni14@yahoo.com
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
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