Comparison the effect of fennel, vitex and placebo oral products on menopausal problems in menopaused women : a double -blind randomized clinical trial
Comparison the effect of Fennel, Vitex and placebo oral products on menopausal problems: A double-blind randomized clinical trial
1
Design
A randomized double-blind, clinical trial with parallel control group, with six blocks, phase 3
Settings and conduct
The capsules will look similar to each other. The study location will be Menopausal clinic of Fatemieh Hospital belongs to Hamadan University of Medical Sciences. Researchers and menopaused women will be blinded.
Participants/Inclusion and exclusion criteria
1- Menopausal women 45-65 years old who have not menstruated for at least one year
2- Do not take another drug to treat menopausal problems
4- Complaining of any of the physical complications of menopause
5- Do not suffer from cardiovascular and liver diseases, Diabet, cancer
7- Not addicted to tobacco and alcohol
Intervention groups
Using the method of six random blocks, people will be randomly assigned to one of the three groups A, B, C. Participants in group A will be given the required number of Fennel capsules, participants in group B will be given a capsule containing Vitex, and those assigned to group c will be given a Placebo.
Main outcome variables
Hot flashes / night sweats
Heart palpitations
Sleep Disorders
Muscle and joint pain
Feeling depressed
Being nervous
Anxiety
Forgetfulness
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20220417054567N1
Registration date:2022-05-23, 1401/03/02
Registration timing:registered_while_recruiting
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Mojgan Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 811 6404
Email address
moj.na1346@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of fennel, vitex and placebo oral products on menopausal problems in menopaused women : a double -blind randomized clinical trial
Public title
Comparison the effect of fennel and vitex
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women 45-65 years who have not been menstruating for at least the past year
Do not take any other medicine to treat menopausal problems
Complaints of any of the physical complications of menopause
No cardiovascular and liver disease
No history of breast or endometrial cancer in yourself or a first-degree family
No addiction to smoking and alcohol
Do not have diabetes
Satisfaction to participate in the project
Exclusion criteria:
Allergy to prescribed drugs
Do not take prescribed medications for at least a week
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
135
More than 1 sample in each individual
Number of samples in each individual:
2
Clinical signs and menopausal problems will be assessed twice at the beginning and end of the study.
Randomization (investigator's opinion)
Randomized
Randomization description
By the method of six random blocks, people will be randomly assigned to one of the three groups A, B, or C. For this purpose, six sheets of paper are prepared. The letter A (intervention with fennel) is written on two sheets, the letter B ( intervention with vitex) is written on two sheets, and the letter C (control) is written on the other two sheets. The sheets are mixed together and selected by the researcher sequentially without replacement. This operation is repeated to the number of eligible patients and the group A, B, or C of each patient is recorded in front of the patient's visit and only with the knowledge of the researcher.
Blinding (investigator's opinion)
Double blinded
Blinding description
Fennel, five-fingered, and placebo are prepared by the researcher in the form of similar capsules and will be given to the doctor. However, the patient's physician and the patient themselves will not know any of the contents of the labeled capsules. The doctor will be told to use capsule 1 for patient # 1. In the same way, all patients are numbered based on their turn and the capsule with the same number is used for them.
Placebo
Used
Assignment
Parallel
Other design features
both women and researchers are blinded
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Hamadan Medical Sciences University
Street address
Boulevard Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2022-04-09, 1401/01/20
Ethics committee reference number
IR.UMSHA.REC.1401.035
Health conditions studied
1
Description of health condition studied
Menopausal singe
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improve menopausal symptoms
Timepoint
At the beginning of the study,4 and 8 weeks later
Method of measurement
Base on research sample
Secondary outcomes
empty
Intervention groups
1
Description
Take fennel capsules containing one gram of fennel fruit once a day
Category
Treatment - Drugs
2
Description
: Vitex Capsule containing VITEX AGNUS-CASTUS product in the amount of 4.8 - 3.2 mg and its standardization according to the composition of Ecobin
Category
Treatment - Drugs
3
Description
Control group: placebo(starch capsule)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Menopause Clinic of Fatemieh Hospital, Hamadan
Full name of responsible person
Dr.Mehdi Biglarkhani,MD, PhD
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
m_research@umsha.ac.ir
Web page address
https://www.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Mehdi Biglarkhani
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
m_research@umsha.ac.ir
Web page address
https://www.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Mehdi Biglarkhani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Fax
+98 81 3838 0717
Email
mahdibiglarkhani@gmail.com
Web page address
http://www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mojgan Nazari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Namjou boulevard
City
Rasht
Province
Guilan
Postal code
3697-419338
Phone
33329421-013 .
Fax
+98 13 3332 6065
Email
moj.na1346@gmail.com
Web page address
http://.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mojgan Nazari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Namjou Boulevard
City
Rasht
Province
Guilan
Postal code
3697-41938 3
Phone
33320963- 013
Fax
+98 13 3332 1972
Email
moj.na1346@gmail.com
Web page address
https://gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available