To determine the effect of Nigella Sativa oil on urinary incontinence and quality of life in menopausal women
Design
Clinical trial with a control group, with parallel groups, triple blinded, randomized with blocking method, phase three on 60 patients. The randomizer software will be used for randomization.
Settings and conduct
The study will be performed on 60 menopausal women who have a record in the health centers of Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 45-60 age group; Passing one year from the last menstrual period after the onset of normal menopause; Not taking of drugs to treat urinary incontinence; Achieving a score of four and higher according to the first three questions and a score of six and higher according to the second three questions of the Questionnaire for Urinary Incontinence Diagnosis (QUID); Having a contact number to follow-up; Living in the city of Tabriz; Having a record in the health center.
Exclusion criteria: Having a history of any physical or mental illness that causes urinary incontinence; Using other medications or traditional medicine to treat urinary incontinence; Presence of urinary tract infection; Allergy to Nigella Sativa
Intervention groups
The intervention group 1 or treatment group: This group will receive Nigella Sativa oil in the form of 2 to 3 drops below the navel on the abdomen and sides twice a day without massage for 8 weeks.;
The intervention group 2 or control group: This group will receive placebo of Nigella Sativa oil in the form of 2 to 3 drops below the navel on the abdomen and sides twice a day without massage for 8 weeks.
Main outcome variables
Urinary incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N67
Registration date:2021-06-08, 1400/03/18
Registration timing:registered_while_recruiting
Last update:2021-06-08, 1400/03/18
Update count:0
Registration date
2021-06-08, 1400/03/18
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-30, 1400/03/09
Expected recruitment end date
2021-09-20, 1400/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nigella Sativa oil on urinary incontinence and quality of life among menopausal women: a triple-blind randomized controlled trial
Public title
The effect of Nigella Sativa oil on urinary incontinence and quality of life among menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
45-60 age group
Passing one year from the last menstrual period after the onset of normal menopause
Not taking of drugs to treat urinary incontinence
Achieving a score of four and higher according to the first three questions of the Questionnaire for Urinary Incontinence (QUID)
Having a contact number to follow-up
Living in the city of Tabriz
Having a record in the health center (SIB system)
Achieving a score of six and higher according to the second three questions of the QUID
Not taking of tobacco and alcohol
Exclusion criteria:
Having a history of any physical or mental illness that causes urinary incontinence
Using other medications or traditional medicine to treat urinary incontinence
Presence of urinary tract infection
Allergy to Nigella Sativa
Using of biofeedback to treat urinary incontinence
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be assigned to two groups (one group receiving Nigella Sativa oil and one group receiving placebo oil with the same protocol) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1. To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer software, and the Nigella Sativa oil and placebo oil will be placed in the same packages numbered sequentially.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, researcher and data analyst will be blinded in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research.
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
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.TBZMED.REC.1400.104
Health conditions studied
1
Description of health condition studied
Urinary incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
Urinary incontinence score
Timepoint
Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil
Method of measurement
Urine Incontinence Questionnaire
Secondary outcomes
1
Description
Score of urinary incontinence specific quality of life
Timepoint
Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil
Method of measurement
Incontinence Quality of Life Instrument
2
Description
Score of Menopause Specific Quality of Life
Timepoint
Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil
Method of measurement
Menopause Specific Quality of Life Questionnaire
3
Description
Sexual function score
Timepoint
Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil
Method of measurement
Female Sexual Function Index
4
Description
Level of satisfaction with the received intervention
Timepoint
8 weeks after the start of consumption of Nigella Sativa oil
Method of measurement
This variable will be measured using an item based on the Likert scale from very satisfied to very dissatisfied.
5
Description
Side events Including pain at the site of drug use, skin complications, increased heart rate, headache and other side events reported by the participant.
Timepoint
8 weeks after the start of consumption of Nigella Sativa oil and during the intervention through participants' report.
Method of measurement
This variable will be measured using a side events checklist designed by the researcher.
Intervention groups
1
Description
Intervention group will receive Nigella Sativa oil in the form of 2 to 3 drops under the navel on the abdomen and sides twice a day without massage for 8 weeks. The oil will be provided by Barij Essence Pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group will receive placebo oil in the form of 2 to 3 drops under the navel on the abdomen and sides twice a day without massage for 8 weeks. The placebo oil will be provided by Barij Essence Pharmaceutical company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tabriz city
Full name of responsible person
Afsaneh Alizadeh
Street address
Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783449
Phone
+98 44 3385 9002
Email
afsanehalizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
mirghafourvand@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afsaneh Alizadeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5714783449
Phone
+98 44 3385 9002
Email
afsanehalizadeh072@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
57147834449
Phone
+98 44 3385 9247
Email
mirghafourvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afsaneh Alizadeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5714783449
Phone
+98 44 3385 9002
Email
afsanehalizadeh072@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available