The aim of this Triple blind randomized controlled trial is to determine the effect of aromatherapy on sexual function in postmenopausal women. We will recruit 180 women from public health centers in Ardabil, Iran. After getting written informed consent, participants will complete a self-administered questionnaire about demographic and reproductive history and also questions about Female Sexual Function Index (FSFI). Then we will randomly allocate them into 3 groups of 60 subjects: two intervention groups and one control group using permuted block randomization with block sizes of tree and six concealed in sequentially numbered identical containers that are administered serially to participants. Participants are randomized to receive first group: aroma solution and placebo Jynkubyluba.The second group: placebo aromas and tablets Jynkubyluba. Third group: placebo aromas and placebo Jynkubyluba .The drops are placed on skin as follows: 2-3 drops three times a day for 6 weeks and tablets 3 times for 6 weeks. The aroma solution contains essential oils of Lavender, Foeniculum vulgare, Geranium, Rose. tablets containing 40 mg herbal Jynkubyluba. The participants will complete FSFI post -test questionnaires weeks after intervention. The mean of difference in sexual function scores are compared among two groups. In this study we keep blinding for participants and researcher and Data Monitoring Committee .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405108170N7
Registration date:2014-06-17, 1393/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-17, 1393/03/27
Registrant information
Name
Jamileh Malakouti
Name of organization / entity
Nursing Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 2699
Email address
malakoutij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Nursing and Midwifery Faculty of Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-09-06, 1393/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginkgo biloba pill and inhalation aromatherapy on sexual function in postmenopausal women: A randomized controlled clinical trial
Public title
The effect of Ginkgo biloba pill and inhalation aromatherapy on sexual function in postmenopausal women
Purpose
Health service research
Inclusion/Exclusion criteria
ability of writing in Persian language؛ age range of 45- 55 years; Being married and living with her husband; Lack of chronic disease; No severe emotional stress in past six months; Natural menopause
Exclusion criteria: No willingness to participate; occurrence of drug side effects and allergy to drugs during the study; occurrence of severe emotional stress such as death of close family; occurrence of psychological complications or severe disease during the study; Living away from husband; hysterectomy,ovarectomy , Cystocele, mastectomy, use of tobacco and alcohol, or herbal drugs, impaired sense of smell, according to one's own and other nasal problems (fractures, SD, rhinitis), gastrointestinal disturbances such as nausea, vomiting, stomach - ache, abdominal cramps, absence of any abnormal vaginal bleeding; Not currently taking drugs affecting on sexual response (anti-hypertension, Thiazide diuretics, anti-depression, anti-histamines, Barbiturates, narcotics, diazepam,amphetamines,cocaine) & no HRT
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research,Tabriz University of Medical Sciences, central building, Golgasht street
City
Tabriz
Postal code
00984114796770
Approval date
2014-05-07, 1393/02/17
Ethics committee reference number
9312
Health conditions studied
1
Description of health condition studied
sexual function during postmenopausal
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual function
Timepoint
Before intervention,6 weeks after intervention
Method of measurement
Female Sexual Function Index (FSFI) that will be self-administered and will be put into a sealed box
Secondary outcomes
1
Description
adverse events
Timepoint
During the intervention
Method of measurement
Checklist
2
Description
the degree of satisfaction
Timepoint
during intervention and aftre intervention
Method of measurement
Check list
Intervention groups
1
Description
the first intervention group aromas solution (containing plant extracts Lavndvr, geranium, fennel and rose) and placebo Jynkubyluba
3 times daily for 6 weeks with 3-2 drops of aromas on the skin and 40mg tablets Jynkubyluba 3 times daily
Category
Treatment - Drugs
2
Description
the secound intervention group tablets containing herbal Jynkubyluba and placebo aromas . 3 times daily for 6 weeks with 3-2 drops of aromas on the skin and 40mg tablets Jynkubyluba 3 times daily .
Category
Treatment - Drugs
3
Description
third, 2 placebo 3 times daily for 6 weeks with 3-2 drops of aromas on the skin and 40mg tablets Jynkubyluba3 times .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Number 17 Health Center
Full name of responsible person
Vahid Lotfollahzade
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Faculty of Nursing and Midwifery, Tabriz Univercity of Medical Scien
Full name of responsible person
Jabbari Freshte
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
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 of Faculty of Nursing and Midwifery, Tabriz Univercity of Medical Scien
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
Tabriz University of Medical Sciences
Full name of responsible person
Malakouti Jamileh
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
malakoutij@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz Univercity of Medical Sciences
Full name of responsible person
Jabbari Freshte
Position
Master of Sciences Student in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
51665118
Phone
+98 411479677
Fax
Email
jabbari.freshte@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz Univercity of Medical Sciences
Full name of responsible person
Jabbari Freshte
Position
Master of sciences student in Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
51665118
Phone
+98 41 1479 6770
Fax
Email
jabbari.freshte@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)