The goal of this study is to assess the effects of Foeniculum vulgare on quality of life and quality of sleep. This was a double-blind, randomized, placebo-controlled trial, single center study, which studied fifty eligible postmenopausal women, who were recruited in Ghaem Hospital in Mashhad. Then, they were randomly assigned to Foeniculum vulgare and placebo group. Quality of life, quality of sleep, depression, anxiety and attitude toward menopause were measured at baseline and after three months. Inclusion criteria: postmenopausal status which was defined as aged aged 45 to 65 with no vaginal bleeding for 1 year; a normal mammogram. The exclusion criteria: use of systemic and tropical estrogen in past six months. Primary outcome included quality of sleep and quality of life and secondary outcome include attitude toward menopause and anxiety and depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092828789N3
Registration date:2017-06-15, 1396/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-15, 1396/03/25
Registrant information
Name
Masumeh Ghazanfarpour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 4230 9487
Email address
ghazanfarpm901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad Unversity of Medical Sceince
Expected recruitment start date
2015-06-14, 1394/03/24
Expected recruitment end date
2016-10-05, 1395/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Foeniculum Vulgare and placebo for sleep quality and quality of life in menopausal women
Public title
the effect of fennel on quality of life and sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy postmenopausal women aged 45 to 65 with no vaginal bleeding for one year; a normal mammogram in the last year
Exclusion criteria: use of systemic and tropical estrogen in past six months.
Age
From 44 years old to 64 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randamation was accomplished using a computerized random number
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Biomedical research, Mashhad University of Medical Sciences- IR.MUMS.REC
Street address
Mashhad Khorasan Razavi Iran, Islamic Republic Of
City
Korsan Razavi
Postal code
Approval date
2014-07-23, 1393/05/01
Ethics committee reference number
Ir.mums. Res. 1393.42
Health conditions studied
1
Description of health condition studied
quality of life in postmenopausal women
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric States
2
Description of health condition studied
Quality of life
ICD-10 code
G47.9
ICD-10 code description
Sleep Disorder, Unspecified
Primary outcomes
1
Description
Attitude toward to menopause questionnaire
Timepoint
before intervention and 90 days after intervention
Method of measurement
Attitude toward to menopause questionnaire
2
Description
Anxiety and depression
Timepoint
before intervention and 90 days after intervention
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
3
Description
sleep quality
Timepoint
before intervention and 90 days after intervention
Method of measurement
Pittsburgh Sleep Quality Index
4
Description
The Menopause-Specific Quality of Life (MENQOL)
Timepoint
before intervention and 90 days after intervention
Method of measurement
The Menopause-Specific Quality of Life (MENQOL) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
100-mg soft capsules containing 30% fennel (Standardized to 21-27 mg anethole), three times a day, for three months
Category
Treatment - Drugs
2
Description
100-mg soft capsules containing sunflower oil, three times a day, for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic of Ghem
Full name of responsible person
Maliheh Afiat
Street address
City
Korsan RAZAVI
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences