The effect of nigella sativa oil on serum levels of Total antioxidant capacity(TAOC) and Malondialdehyde(MDA) in patients with polycystic ovarian syndrome
Determining the effect of nigella sativa oil on serum level of Malondialdehyde(MDA) , Total antioxidant capacity(TAOC) and lipid profile in patient with polycystic ovarysyndrome.
Design
The study is conducted in an interventional (phase 3 clinical trial) and on 60 patients with polycystic syndrome .patients will be randomly divided into two groups of 30 using envelopes containing medicine and placebo and two blinders.the case groups will be given black seed oil at dose of 1000 mg daily for 12 weeks, and the control group will be given a placebo drug at the same dose and time
Settings and conduct
The study is conducted on 60 patients with polycystic syndrome referred to the obstetrics and Gynecology clinic of Alavi Hospital in ardabil.patients will be randomly divided into two groups. black seed oil will be given to the case group for 12 weeks and placebo to the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Menstural cycle disorders,clinicalor biochemical hyperandrogenism and sonographic appearance of polycystic syndrome
Exclusion criteria:Type 2 diabets,adernal hyperplasia,thyroid diseases,autoimmune diseases and hyperprolactinemia,diet and special drug use
Intervention groups
The case group received 12 weeks of blackseed oil with a dose of 1000 mg daily and the placebo drug control group with the same dose and time
The effect of nigella sativa oil on serum levels of Total antioxidant capacity(TAOC) and Malondialdehyde(MDA) in patients with polycystic ovarian syndrome
Public title
Effect of Nigella sativa oil in patients with polycystic ovary
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Oligomenorrhea or lack of ovlation
polycystic ovaries based on ultrasound
Androgenic hormone changes in laboratory or clinical form (the presence of hirsutism)
Exclusion criteria:
Type 2 diabets
Thyroid disease
Adernal hyperplasia
Autoimmune disease
Hyperprolactinemia
People with structured physical activity or scheduled exercise
If three months before entering the study,they use a special diet or special drugs that may affect the results ,they will be excluded from the study ,such as anti-obesity drugs,induction ovulation,antidepressants,insulin sensivity,oral contraceotives,asprin,and anti-prostaglandin drugs
If there are signs of pregnancy,they will be excludedfrom the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using envelopes (A and B) containing medicine and placebo,theywill be randomly divided into two groups.Basedon the calculated sample size,30envelops A and 30 envelops B are placed in a lottery container,and then the envelops are randomly removed from the container without replacement and the created sequence will be recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, double-blind will be used so that patientand the student who providesthe envelope to the patient will be blind to the content of the envelops (intervention or placebo)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil university of Medival sciences
Street address
Faculty of medicine,1st floor,university street, 8599156189
City
Ardabil
Province
Ardabil
Postal code
8599156189
Approval date
2023-08-17, 1402/05/26
Ethics committee reference number
IR.ARUMS.REC.1402.128
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Malondialdehyde(MDA)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level
2
Description
Total antioxidant capacity(TAOC)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level
Secondary outcomes
1
Description
Triglyceride
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level
2
Description
cholesterol
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level
3
Description
High-density lipoprotein (HDL)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level
4
Description
Low-density lipoprotein (LDL)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level
Intervention groups
1
Description
Intervention group:subjects receiving black seed oil,In this group,subgects will receive capsules containing black seed oil with a dose of1000 mg per day orally for three months.Black seed oil capsules will be provided by Barij Essans oil company(kashan).
Category
Treatment - Drugs
2
Description
Control group: subjects receiving placebo capsules,in this group ,subjects will receive capules containing placebo,which are similar to capsules containing black seed oil in terms of shape,color and side ingredients,orally daily for three months.placebo capsules will be provided from Barij Essans oil company(kashan).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Ardabil Hospital
Full name of responsible person
SHahla Farzipour
Street address
Sport field-Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
shahla.farzipour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
SHahla farzipour
Street address
Sport field-Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
shahla.farzipour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
80
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
Ardabil University of Medical Sciences
Full name of responsible person
SHahla Farzipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sport field-Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
shahla.farzipour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
SHahla Farzipour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sport field-Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
shahla.farzipour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Negin Panahi kaleybar
Position
Resident of gynecology and obstetrics
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sport field-Ardabil Hospital
City
Ardabil
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 45 3324 8888
Email
Negin.panahi69@gmail.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic,clinical and outcome data
When the data will become available and for how long
No time limit
To whom data/document is available
Journal if needed
Under which criteria data/document could be used
With permission from the university Ethics committee
From where data/document is obtainable
corresponding
What processes are involved for a request to access data/document
A written request from the relevent unit and permission from the university Ethics committee