The triple-blind randomized controlled clinical trial will be conducted to assess the effect of fennel(Foeniculum Vulgar) on menopausal symptoms in postmenopause women.
Inclusion criteria: women aged between 45-60 years; married women; women in the first 1-5 years of their post menopausal period; achieving a minimum score of 9 by women according to Menopause Rating Scale questionnaire ( middle severity of menopausal symptoms); Negative history of physical and psychological diseases; Negative history of hormone therapy and complementary medicine for menopausel symptoms; Negative history of Allergy to herbal medicine; Negative history of sedative and anti depressant drugs usage; Negative history of addiction and smoking; women with at least the ability to read and write.
exclusion criteria: allergy to foeniculum vulgare during the intervention; worsening the disease during the intervention; poor cooperation during the intervention; stop using foeniculum vulgare/placebo for at least 6 days; using of other remedies for menopausal symptoms during the study. Following approval of proposed study design, the study sample of 90 women, attending clinics affiliated to Tehran University of Medical Sciences, will be assigned randomly into two groups (intervention / control group) and they will receive two capsules of fennel (100mg fennel soft capsules) or placebo ( 100mg sunflower oil soft capsules) daily for 8 weeks. The primary outcome (Severity of Menopausal Symptoms score) will be assessed by Menopause Rating Scale questionnaire (MRS) questionnaire before intervention and at 4th,8th and 10th week of the intervention. Secondary outcomes (Severity score of physical symptoms ,Severity score of psychological symptoms, Severity score of urogenital symptoms) will be assessed by MRS questionnaire (physical symptoms, psychological symptoms and urogenital symptoms parts) at the same time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050827788N1
Registration date:2016-05-26, 1395/03/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-26, 1395/03/06
Registrant information
Name
Parvin Golzareh
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 937 821 4212
Email address
saharrezaie1980@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-08-10, 1395/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fennel (Foeniculum Vulgar) oral capsules on menopausal symptoms in postmenopausal women: Triple blind randomized clinical trial
Public title
The effect of fennel(Foeniculum Vulgar) oral capsules on menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged between 45-60 years; married women; women in the first 1-5 years of their post menopausal period; achieving a minimum score of 9 by women according to Menopause Rating Scale questionnaire ( middle severity of menopausal symptoms); Negative history of physical and psychological diseases; Negative history of hormone therapy and complementary medicine for menopausel symptoms; Negative history of Allergy to herbal medicine; Negative history of sedative and anti depressant drugs usage; Negative history of addiction and smoking; women with at least the ability to read and write.
exclusion criteria: allergy to foeniculum vulgare during the intervention; worsening the disease during the intervention; poor cooperation during the intervention; stop using foeniculum vulgare/placebo for at least 6 days; using of other remedies for menopausal symptoms during the study
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, participants will be assigned to test and control groups using Random Number Table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Iran, tehran, Enghelab street, Ghods street
City
Tehran
Postal code
1417614411
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.TUMS.REC.1394.1973
Health conditions studied
1
Description of health condition studied
menopausal symptoms
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Severity score of Menopausal Symptoms
Timepoint
Before intervention, at the end of 4th, 8th and 10th week of intervention.
Method of measurement
Menopause Rating Scale questionnaire
Secondary outcomes
1
Description
Severity score of physical symptoms, Severity score of psychological symptoms, Severity score of urogenital symptoms
Timepoint
Before intervention, at the end of 4th, 8th and 10th week of intervention.
Method of measurement
MRS questionare
Intervention groups
1
Description
Intervention group : 100mg fennel oral capsules, twice a day for 8 week.
Category
Treatment - Drugs
2
Description
Control group: 100mg sunflower oil oral capsule, twice a day for 8 week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farmanfarmayian clinic
Full name of responsible person
Seyedeh Effat Ramezaninejad, Bachelor of Scinence in Nursing
Street address
Between Golshan and Bastan street, Azarbayejan street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
No23, Valiasr Avenue, Dameshgh Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Sciences
Full name of responsible person
Parvin Golzareh
Position
MS student in Midwifery Education
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6105 4312
Fax
Email
golzareh23@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Rahimikian
Position
MS in Midwifery Education, Faculty member of TUMS
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Tehran University of Medical Sciences, East Nosrat Avenue,Towhid square
City
Tehran
Postal code
Phone
+98 21 6105 4312
Fax
Email
rahimikian@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of medical Sciences
Full name of responsible person
Parvin Golzareh
Position
M.Sc student in Midwifery Education
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
Fax
Email
golzareh23@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)