The effect of Nigella Sativa oil on urinary incontinence and quality of life among menopausal women

The effect of Nigella Sativa oil on urinary incontinence and quality of life among menopausal women: a triple-blind randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120718010324N67

Enrollment

Registered

2021-06-08

Start date

2021-05-30

Completion date

Unknown

Last updated

2021-06-21

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

Conditions

Urinary incontinence. Other specified urinary incontinence

Interventions

Intervention 1: Intervention group will receive Nigella Sativa oil in the form of 2 to 3 drops under the navel on the abdomen and sides twice a day without massage for 8 weeks. The oil will be provide

Eligibility

Sex/Gender

Female

Age

45 Years to 60 Years

Inclusion criteria

Inclusion criteria: 45-60 age group Passing one year from the last menstrual period after the onset of normal menopause Not taking of drugs to treat urinary incontinence Achieving a score of four and higher according to the first three questions of the Questionnaire for Urinary Incontinence (QUID) Having a contact number to follow-up Living in the city of Tabriz Having a record in the health center (SIB system) Achieving a score of six and higher according to the second three questions of the QUID Not taking of tobacco and alcohol

Exclusion criteria

Exclusion criteria: Having a history of any physical or mental illness that causes urinary incontinence Using other medications or traditional medicine to treat urinary incontinence Presence of urinary tract infection Allergy to Nigella Sativa Using of biofeedback to treat urinary incontinence

Design outcomes

Primary

Measure	Time frame
Urinary incontinence score. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Urine Incontinence Questionnaire.	—

Secondary

Measure	Time frame
Score of urinary incontinence specific quality of life. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Incontinence Quality of Life Instrument.;Score of Menopause Specific Quality of Life. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Menopause Specific Quality of Life Questionnaire.;Sexual function score. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Female Sexual Function Index.;Level of satisfaction with the received intervention. Timepoint: 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: This variable will be measured using an item based on the Likert scale from very satisfied to very dissatisfied.;Side events Including pain at the site of drug use, skin complications, increased heart rate, headache and other side events reported by the participant. Timepoint: 8 weeks after the start of consumption of Nigella Sativa oil and during the intervention through participants' report. Method of measurement: This variable will be measured using a side events checklist designed by the researcher.	—

Measure

Time frame

Score of urinary incontinence specific quality of life. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Incontinence Quality of Life Instrument.;Score of Menopause Specific Quality of Life. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Menopause Specific Quality of Life Questionnaire.;Sexual function score. Timepoint: Before the intervention and 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: Female Sexual Function Index.;Level of satisfaction with the received intervention. Timepoint: 8 weeks after the start of consumption of Nigella Sativa oil. Method of measurement: This variable will be measured using an item based on the Likert scale from very satisfied to very dissatisfied.;Side events Including pain at the site of drug use, skin complications, increased heart rate, headache and other side events reported by the participant. Timepoint: 8 weeks after the start of consumption of Nigella Sativa oil and during the intervention through participants' report. Method of measurement: This variable will be measured using a side events checklist designed by the researcher.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsaneh Alizadeh

Tabriz University of Medical Sciences

afsanehalizadeh072@gmail.com+98 44 3385 9002

Outcome results

None listed

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