Objective: The current research seeks to compare the effect of fennel extract and placebo on the improvement of menopausal symptoms. Design: The research is a randomized clinical, double-blind, and placebo- control trial. Set up: the intervention period lasts eight weeks. First, demographic and green inventories are filled out by the participants. The samples are randomly divided into two distinct categories. Participants: The samples are comprised of 50 menopausal women aged 45 to 60 years old. Inclusion criteria: the women ranging from 45 to 65 years old; menstrual period is elapsed minimally one year and maximally three years; the number of their hot flushes is at least 2 times a day. Exclusion criteria: smoking; undergoing hormone; antibiotics therapy for a period of 3 months at least; systemic diseases such as kidney disease; blood pressure; diabetes; blood fat; depression and anxiety (anxiety and depression diagnosis based on diagnostic criteria DSM5 by psychiatrist); taking anti-thyroid drugs; gabapentin; SSRI; sulfonamides; methotrexate; Tryamtryn; sulfasalazine; estrogen; uptake of traditional medicines such as drug-induced flushing. Intervention: One group takes fennel extract capsules twice a day, and another group uptakes placebo twice a day for 8 weeks. At the end of the 2nd, 4th, and 8th weeks, the participants fill out the questionnaires again. Outcome: The final outcome of the current research is an improvement in menopausal symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120528967N4
Registration date:2017-02-13, 1395/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-13, 1395/11/25
Registrant information
Name
Safora Salemi
Name of organization / entity
Shahid Chamran University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 83 3821 1001
Email address
e.mahmoudi@cobeldarou.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-01-05, 1395/10/16
Expected recruitment end date
2017-10-09, 1396/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Fennel extract in the treatment of menopausal symptoms compared with placebo
Public title
Comparing the effect of Fennel extract and placebo on menopausal symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the women ranging from 45 to 65 years old; menstrual period is elapsed minimally one year and maximally three years; the number of their hot flushes is at least 2 times a day. Exclusion criteria: smoking; undergoing hormone; antibiotics therapy for a period of 3 months at least; systemic diseases such as kidney disease; blood pressure; diabetes; blood fat; depression and anxiety (anxiety and depression diagnosis based on diagnostic criteria DSM5 by psychiatrist); taking anti-thyroid drugs; gabapentin; SSRI; sulfonamides; methotrexate; Tryamtryn; sulfasalazine; estrogen; uptake of traditional medicines such as drug-induced flushing.
Age
From 45 years old to 65 years old
Gender
Female
Phase
2
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
kums.rec.1395.449
Health conditions studied
1
Description of health condition studied
menopausal symptoms
ICD-10 code
o95
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
Primary outcomes
1
Description
Vasomotor
Timepoint
before intervention-2 weeks later- 4 weeks later- 8 weeks later
Method of measurement
Green questionnaire
2
Description
Depression
Timepoint
before intervention-2 weeks later- 4 weeks later- 8 weeks later
Method of measurement
Green questionnaire
3
Description
Sexual Function
Timepoint
before intervention-2 weeks later- 4 weeks later- 8 weeks later
Method of measurement
Green questionnaire
4
Description
Anxiety
Timepoint
before intervention-2 weeks later- 4 weeks later- 8 weeks later
Method of measurement
Green questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First group will be given fennel extract, 2 times daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Second group will be given placebo, 2 time daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Red Crescent clinics
Full name of responsible person
Ali Rahmani
Street address
Shahid Beheshti Blvd,Red Crescent clinics
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Psychiatrist
Other areas of specialty/work
Street address
Isar square, Farabi Hospital
City
Kermanshah
Postal code
Phone
+98 833826451
Fax
Email
vfarnia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical
Full name of responsible person
Safora Salemi
Position
Pychologist
Other areas of specialty/work
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+98 83 3821 1001
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)