The effect of Nigella sativa oil soft capsule on early menopausal symptom and oxidative markers

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20110606006709N19

Enrollment

Registered

2019-04-14

Start date

2018-12-26

Completion date

Unknown

Last updated

2019-04-23

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

Conditions

menopause. Menopausal and female climacteric states

Interventions

Intervention 1: 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. Intervention 2: Control grou

Eligibility

Sex/Gender

Female

Age

45 Years to 60 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Total and subdomains scores of early menopause symptoms. Timepoint: Before intervention, 4 and 8 weeks after intervention. Method of measurement: Greene scale.;Serum antioxidant levels (TAC). Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Biochemical methods.;Serum oxidative stress index (MDA). Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Biochemical methods.	—

Measure

Time frame

Total and subdomains scores of early menopause symptoms. Timepoint: Before intervention, 4 and 8 weeks after intervention. Method of measurement: Greene scale.;Serum antioxidant levels (TAC). Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Biochemical methods.;Serum oxidative stress index (MDA). Timepoint: Before interventions and 8 weeks after intervention. Method of measurement: Biochemical methods.

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Secondary

Measure	Time frame
Frequency of hot flashes. Timepoint: Before interventions, 4 and 8 weeks after intervention. Method of measurement: Checklist for daily counts Frequency of hot flashes.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoghayeh Azami

Tabriz University of Medical Sciences

r.azmi5392@gmail.com+98 41 3476 9372

Outcome results

None listed

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