The goal of this study is to assess the effects of Foeniculum vulgare on bone density and lipid profile. This study was a double-blind, randomized, placebo-controlled trial, which studied sixty eligible postmenopausal women, who were recruited in Imam Reza Hospital in Mashhad. Then, they were randomly assigned to fennel and placebo groups. Lipid profiles including total, low density
lipoprotein (LDL) and HDL cholesterol as well as triacylglycerol were measured. The dual energy X-ray absorptiometry was utilized to measure bone mineral density (BMD) and bone mineral content (BMC) of the spine, femoral neck, Intertrochanter, and Trochanter at baseline and after three months. Inclusion criteria are as follows: postmenopausal status which was defined as aged over 40 years with no vaginal bleeding for 1 year; no regular ingestion of phytoestrogen or soy-based products; having a normal mammogram in the last year. The exclusion criteria were: use of any fluoride or bisphosphonates; diseases or medications affecting bone metabolism; Currently (or in the past 6 months) using estrogen or calcitonin; medication for lowering lipids or blood pressure; diabetes mellitus; no regular physical exercise or allergy to Foeniculum vulgare
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070428789N1
Registration date:2016-10-02, 1395/07/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-02, 1395/07/11
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 University of Medical Sciences, Mashhad, Iran Mashhad, Iran
Expected recruitment start date
2015-07-31, 1394/05/09
Expected recruitment end date
2016-04-08, 1395/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy Foeniculum vulgare and placebo on bone density and lipid profile in postmenopausal women
Public title
Foeniculum vulgareon bone and lipid profile
Purpose
Treatment
Inclusion/Exclusion criteria
postmenopausal status, which was defined as aged between 45-65 with no vaginal bleeding for 1 year no regular ingestion of phytoestrogen or soy-based products ; having a normal mammogram in the last year.The exclusion criteria were : use of any fluoride or bisphosphonates; diseases or medications affecting bone metabolism; Currently (or in the past 6 months) using estrogen or calcitonin; medication for lowering lipids or blood pressure diabetes mellitus; no regular physical exercise or allergy to
Age
From 44 years old to 64 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
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
Ghoreishi building Daneshgah street Mashhad Khorasan Razavi Iran, Islamic Republic Of
City
Mashhad
Postal code
Approval date
2015-04-15, 1394/01/26
Ethics committee reference number
IR.MUMS.ir.ac.1392.151
Health conditions studied
1
Description of health condition studied
menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
High density lipoprotein (HDL)
Timepoint
before and 90 days after treatment
Method of measurement
biochemical test
2
Description
Osteoporosis
Timepoint
before intervention and 90 days after intervention
Method of measurement
the dual energy X-ray absorptiometry was utilized to measure bone mineral density (BMD)
3
Description
low density lipoprotein (LDL)
Timepoint
beforer and after tratment
Method of measurement
biochemical test
4
Description
Total cholesterol
Timepoint
before and 90 days after treatment
Method of measurement
biochemical test
5
Description
Triglycerides
Timepoint
Before and after 90 days treatment
Method of measurement
biochemical test
Secondary outcomes
empty
Intervention groups
1
Description
Foeniculum vulgare 30 mg soft capsule, three times a day,12 week
Category
Treatment - Drugs
2
Description
placebo capsule 30 mg soft capsule, three times a day,12 week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic of Emam Reza
Full name of responsible person
Maliheh Afiat
Street address
Gynecology Clinic, Emam Reaza Hospital, Ebn-e Sina Street, Mashhad, Khorasan-e-Razavi,
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research