Comparing the effect of Nigella sativa oil soft capsule and placebo on early menopausal symptom and serum levels of some oxidative markers in Postmenopausal women: A triple blind randomized controlled clinical trial
Effect of Nigella Sativa oil soft capsule on early menopausal symptom and serum levels of some oxidative markers in menopausal women
Design
Two parallel arm Randomized Controlled Trial
Settings and conduct
This study will be conducted at community health centers in Tabriz. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment. Eligible women will be randomly assigned into two groups of 72 subjects with block sizes of 4 and 6, stratified by menopausal status.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 45 and 60 years;
Not having a menstrual period over the past 12 months;
Gaining score 15 to 42 in Green scoring system;
Having a normal menopause;
Menopause over the past 5 years.
Non inclusion criteria:
Smoking and drinking alcoholic beverages;
Existence of stressors;
The presence of estrogen-dependent diseases;
History of liver disease;
Use herbal or hormonal medications to relieve menopausal symptoms.
Intervention groups
Intervention group: Nigella Sativa oil 1000 mg soft capsule, produced by Baryj Essence pharmaceutical company, orally once a day for 8 weeks
Control group: Nigella Sativa placebo soft capsule containing 1000 mg Lactose produced by Baryj Essence pharmaceutical company once a day, orally for 8 weeks.
Main outcome variables
Total and subdomains scores of early menopause symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110606006709N19
Registration date:2019-04-14, 1398/01/25
Registration timing:registered_while_recruiting
Last update:2019-04-14, 1398/01/25
Update count:0
Registration date
2019-04-14, 1398/01/25
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-26, 1397/10/05
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Nigella sativa oil soft capsule and placebo on early menopausal symptom and serum levels of some oxidative markers in Postmenopausal women: A triple blind randomized controlled clinical trial
Public title
The effect of Nigella sativa oil soft capsule on early menopausal symptom and oxidative markers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bing at the age of 45-60 years old
Not having a menstrual period over the past 12 months
Earning a score between 15-42 in the Green Assessment Hot flashes
Having a normal menopause
Menopause over the past 5 years (less than 5 years from start of menopause)
Having a normal blood pressure (100/60 to 140 / 90)
Exclusion criteria:
The use of tobacco and alcohol
The presence of stressors such as the death of relatives of the first class in the last 6 months
The presence of estrogen-dependent diseases
The use of certain dietary regimens And regular blackberry consumption in the individual
Allergic to spices and essential substances
A history of a history of liver disease, depression or hyperthyroidism
The use of hormonal or herbal medicines to treat menopausal symptoms or nervous system medications for the last 3 months during the study
use of hypertension druges
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
Data and Safety Monitoring Board
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Menopausal women aged 45- 60 years or older will be randomly assigned into two groups of recipients of training or control using random blocking method and blocks of size 4 and 6 using Random Allocation Software (RAS) with a 1: 1 assignment ratio by the person not involved in the research. To conceal the allocation, the name of group will be placed inside a consecutively numbered sealed opaque envelopes. Preparation of envelopes and sequence generation will be done by a person not involved in participant recruitment or data collection.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug and the placebo will be prepared by the same pharmaceutical company in identical shape, color and smell. Investigators, health care providers, outcome assessors, and statistical analyst will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی تبریز
Street address
Research 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
2019-03-12, 1397/12/21
Ethics committee reference number
IR.TBZMED.REC.1397.1034
Health conditions studied
1
Description of health condition studied
menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Total and subdomains scores of early menopause symptoms
Timepoint
Before intervention, 4 and 8 weeks after intervention
Method of measurement
Greene scale
2
Description
Serum antioxidant levels (TAC)
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
Biochemical methods
3
Description
Serum oxidative stress index (MDA)
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
Biochemical methods
Secondary outcomes
1
Description
Frequency of hot flashes
Timepoint
Before interventions, 4 and 8 weeks after intervention
Method of measurement
Checklist for daily counts Frequency of hot flashes
Intervention groups
1
Description
Intervention group: They will use Nigella Sativa oil soft capsule 1000 mg once a day prepared by Baryj Essence pharmaceutical company, orally for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group:They will use Nigella Sativa placebo soft capsule containing 1000 mg Lactose once a day, prepared by Baryj Essence pharmaceutical company, orally for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers selected in Tabriz
Full name of responsible person
Roghayeh Azami
Street address
Faculty of Nursing and Midwifery, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3444 0057
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://tabriz-phc.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3335 7310
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://researchvice.tbzmed.ac.ir
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
Roghayeh Azami
Position
Msc Student of Midwifery
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
5155884818
Phone
+98 41 3476 9372
Fax
+98 41 3479 6969
Email
r.azmi5392@gmail.com
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Shahnazi mansori
Position
assistant professor
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
5138947977
Phone
+98 41 1477 2699
Fax
+98 41 3479 6969
Email
mshahnazi@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roghayeh Azami
Position
Master of sciences student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5155884818
Phone
+98 41 1477 2699
Fax
+98 41 3479 6969
Email
r.azami5392@gmail.com
Web page address
http://nursing.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available