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The effect of sativa Nigella sativa oil on serum levels of IL-6, TNF- alpha, insulin and lipid profiles in patients with polycystic ovarian syndrome

Protocol summary

Study aim
Determining the effect of black seed oil on serum levels of IL-6, TNF-α, insulin, fasting blood sugar, insulin resistance, insulin sensitivity and lipid profile in patients with polycystic ovary syndrome.
Design
The study is conducted in an interventional way (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 group will be given black seed oil at a 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: Menstrual cycle disorders, clinical or biochemical hyperandrogenism and sonographic appearance of polycystic syndrome Exclusion criteria: Type 2 diabetes, adrenal hyperplasia, thyroid disease, autoimmune diseases and hyperprolactinemia, diet and special drug use
Intervention groups
The case group received 12 weeks of black seed oil with a dose of 1000 mg daily and the placebo drug control group with the same dose and time.
Main outcome variables
Interleukin 6, TNF-alpha, insulin, fasting blood sugar, insulin sensitivity index, insulin resistance index, Lipid profile

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230125057222N1
Registration date: 2023-08-19, 1402/05/28
Registration timing: prospective

Last update: 2023-08-19, 1402/05/28
Update count: 0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Samaneh Jamshidian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3324 8888
Email address
jamshidian.925@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-07, 1402/06/16
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sativa Nigella sativa oil on serum levels of IL-6, TNF- alpha, insulin and lipid profiles in patients with polycystic ovarian syndrome
Public title
Effect of Nigella sativa oil in patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Oligomenorrhea or lack of ovulation Polycystic ovaries based on ultrasound Androgenic hormone changes in laboratory or clinical form (the presence of hirsutism)
Exclusion criteria:
Type 2 diabetes - thyroid disease - adrenal hyperplasia autoimmune diseases - - 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, ovulation stimulants, antidepressants, insulin sensitivity, oral contraceptives, aspirin, and Anti-prostaglandin drugs If there are signs of pregnancy, they will be excluded from the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Using envelopes (A and B) containing medicine and placebo, they will be randomly divided into two groups. Based on the calculated sample size, 30 envelopes A and 30 envelopes B are placed in a lottery container, and then the envelopes 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 the patient and the student who provides the envelope to the patient will be blind to the content of the envelopes (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 Medical Sciences
Street address
Faculty of Medicine, 1st floor, University Street, 8599156189, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
8599156189
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.ARUMS.REC.1401.215

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
Interleukin 6,
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level

2

Description
TNF-alpha
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level

3

Description
lipid profile
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level

4

Description
insulin
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level

5

Description
fasting blood sugar
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Determination of serum level

Secondary outcomes

1

Description
Insulin resistance index (QUICKI), insulin sensitivity index (HOMA-IR)
Timepoint
Before and 12 weeks after the intervention
Method of measurement
Calculation of indices

Intervention groups

1

Description
Intervention group:subjects receiving black seed oil. In this group, subjects will receive capsules containing black seed oil with a dose of 1000 mg per day orally for three months. Black seed oil capsules will be provided by Barij Essential Oil Company (Kashan).
Category
Treatment - Drugs

2

Description
Control group: Subjects receiving placebo capsules. In this group, subjects will receive capsules 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 Essan Company (Kashan).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alavi Ardabil Hospital
Full name of responsible person
Faranak Jalilvand
Street address
Sports field - Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
faran.jalil@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Faranak Jalilvand
Street address
Sports field - Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
faran.jalil@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
Faranak Jalilvand
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sports field - Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
Email
faran.jalil@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Faranak Jalilvand
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sports field - Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
faran.jalil@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Samaneh Jamshidian
Position
Resident women
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Sports field - Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
0094533248888
Email
jamshidian.925@gmailo.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 relevant unit and permission from the university's ethics committee
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