Effect of Nigella sativa oil in patients with polycystic ovary syndrome

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230125057222N1

Enrollment

Registered

2023-08-19

Start date

2023-09-07

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: 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. Bl

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Interleukin 6,. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.;TNF-alpha. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.;Lipid profile. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.;Insulin. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.;Fasting blood sugar. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.	—

Measure

Time frame

Interleukin 6,. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.;TNF-alpha. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.;Lipid profile. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.;Insulin. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.;Fasting blood sugar. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Determination of serum level.

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Secondary

Measure	Time frame
Insulin resistance index (QUICKI), insulin sensitivity index (HOMA-IR). Timepoint: Before and 12 weeks after the intervention. Method of measurement: Calculation of indices.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaranak Jalilvand

Ardabil University of Medical Sciences

faran.jalil@gmail.com+98 45 3324 8888

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026