Effect of Nigella sativa oil in patients with polycystic ovary syndrome

Phase 3

Recruiting

Conditions: Polycystic ovary syndrome.
Polycystic ovarian syndrome
E28.2

Registration Number: IRCT20230125057222N1

Lead Sponsor: Ardabil University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 60

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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