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

Phase 3

• Conditions: Condition 1: Hot flashes. Condition 2: sleep disorders.; Menopausal and female climacteric states; Sleep disorders; N95.1

• Registration Number: IRCT20180514039660N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 94

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.