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The effect of viola odorata syrup on hot flashes and sleep quality in postmenopausal women

The effect of viola odorata syrup on hot flashes and sleep quality in postmenopausal women

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180514039660N1
Enrollment
94
Registered
2018-08-07
Start date
2018-06-22
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Condition 1: Hot flashes. Condition 2: sleep disorders. Menopausal and female climacteric states Sleep disorders

Interventions

Intervention 1: Intervention group: Violet Flower Syrup from Barís Essence, every 5 ml of flavonoid containing syrup is 16.25-9 mg. The units are taking 5 ml every other day forone month each two time
the units are taking 5 ml every other day forone month each two times a day.

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: At least the reading and writing skills Post-menopausal (at least 12 months of self-deprivation of menstruation, without contact with pregnancy and lactation, or other medical and pharmaceutical reasons or serum FSH> 40 IU / L). Experience at least 3 hot flashes throughout the day Having a sleep quality score higher than 5 Age 40 to 65 years old

Exclusion criteria

Exclusion criteria: Tobacco and alcohol consumption Hormone therapy in the last 6 months Having depression, stress or severe anxiety (score less than 19 below the stress scale, score less than 10 below the anxiety scale or score less than 14 below the depression scale of the DASS-21 questionnaire) Having physical illnesses (such as diabetes, hypertension, pulmonary, heart, infectious diseases, cancers) Mental illness Infectious and febrile illnesses (such as respiratory, urinary and hepatitis infections, thyroid disease, and those with hot flush as one of their symptoms). Concomitant use of hypnotic and herbal medicines affecting sleep and hot flashes (such as soy and herbs) Taking medications that improve vasomotor symptoms (such as clonidine, antidepressants, tamoxifen, raloxifene, anticonvulsants like gabapentin) Use of anti-coagulants, anti-anxiety and non-steroidal drugs Having a night shift The use of isoflavone absorption inhibitors during the study, such as antibiotics for 6 weeks, and proton pump inhibitors (omeprazole, lansoprazole, ropiperazole, pantoprazole, osomoperazole)

Design outcomes

Primary

MeasureTime frame
Hot flashes. Timepoint: From a week before the study begins to immediately after the intervention. Method of measurement: Hot flashes daily registration form.;Sleep quality. Timepoint: Before starting the study until immediately after the intervention. Method of measurement: Pittsburg Sleep Quality Index.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Lotfi

Mashhad University of Medical Sciences

lotfif951@mums.ac.ir+98 51 3859 1511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 9, 2026