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Comparison of the effect of Fennel capsule and Vitamin E capsule on menopausal symptoms in women:a randomized placebo-controlled clinical trial

Protocol summary

Study aim
Comparison of the effect of Fennel capsule and Vitamin E capsule on menopausal symptoms in women
Design
A parallel randomized double-blind placebo-controlled trial on 105 menopausal women (3 groups/each group of 35 participants with an attrition rate of 20%); A blocked randomization method using an online randomization service, Sealed Envelope Ltd. 2019
Settings and conduct
Eligible menopausal women referring to Al-Zahra hospital will be allocated into Fennel, Vitamin E, and placebo capsule groups using blocked randomization. Data will be collected using the demographic, IPAQ questionnaires, and MRS scale. The fennel group will receive 30 mg fennelin soft capsules, the vitamin E group will receive a capsule containing 200 IU of vitamin E, and the control group will receive a placebo capsule twice a day for 8 weeks. The MRS scale will be completed before, 4, and 8 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Willingness and sign the written informed consent; Ability to read and write; Normal menopause and age over 40 years; Lapse of at least 12 months since the last menstruation, according to the Stages of Reproductive Aging Workshop+10 (STRAW+10) criteria; Menopause less than 5 years; Having a score of 9 and above on the Menopause Rating Scale (MRS); No history of diseases such as respiratory, kidney, coagulation, hemophilia, inflammatory, liver, gallstones, cancer, epilepsy, seizures, and uterine diseases; No Allergy reaction to celery and fennel; No taking immunosuppressive drugs, anticoagulants, neuropsychiatric, antioxidant supplements, herbal drugs; No hormone therapy; No Smoking/alcohol consumption; No Stressful factors
Intervention groups
Fennel capsule and vitamin E capsule (intervention groups) and placebo capsule (control group)
Main outcome variables
Menopausal symptoms score based on the MRS scale before, 4, and 8 weeks after the intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160630028717N4
Registration date: 2024-03-16, 1402/12/26
Registration timing: prospective

Last update: 2024-03-16, 1402/12/26
Update count: 0
Registration date
2024-03-16, 1402/12/26
Registrant information
Name
Parvaneh Rezasoltani
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
rezasoltani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Fennel capsule and Vitamin E capsule on menopausal symptoms in women:a randomized placebo-controlled clinical trial
Public title
Comparison of the effect of Fennel capsule and Vitamin E capsule on menopausal symptoms in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and sign a written informed consent form At least ability to read and write Women with normal menopause and age over 40 years Lapse of at least12 months since the last menstruation, according to the Stages of Reproductive Aging Workshop+ 10 (STRAW+10) criteria Menopause less than 5 years (according to the person's statement) Having a score of 9 and above on the Menopause Rating Scale (MRS)
Exclusion criteria:
History of respiratory disease (asthma and allergy), kidney disease, coagulation disease, hemophilia, inflammatory disease, liver disease and gallstones, cancer, epilepsy/seizures, and uterine diseases (such as fibroids, adenomyosis, and endometriosis). Allergy reaction to celery and fennel Taking immunosuppressive drugs, anticoagulants (such as warfarin and heparin), neuropsychiatric drugs, antioxidant supplements, herbal drugs, and hormone therapy Smoking and alcohol consumption Stressful factors (such as the death of a first-degree relative in the last 6 months and job loss)
Age
From 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all eligible individuals will be equally allocated into three Fennel, Vitamin E, and placebo capsule groups by blocked randomization with the size of 3 and 6 blocks (by the statistical consultant of this project). Allocation of samples to groups will be performed using an online randomization service, Sealed Envelope Ltd. 2019 (Available at https://www.sealedenvelope.com/). Also, for allocation concealment will be used by sequentially numbered, Opaque, Sealed Envelopes (SNOSE).
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind and the participants and the investigator will be unaware of the content of capsule inside these packages. For blinding, the pharmacist colleague will pack the Fennel, Vitamin E, and placebo capsules in the same shape and size opaque packages and tag the specific code based on random block allocation without the intervention and knowledge of the investigator. Then, these packages will be delivered to the investigator. The investigator/student will allocate the participants in each one of the three groups based on inclusion criteria and blocked randomization and provide these packages containing these capsules to the participants for free of charge.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committee of Guilan University of Medical Sciences
Street address
Vice Chancellor of Research and Technology of Guilan University of Medical Sciences (GUMS), In front of 17 Shahrivar Hospital, Shahid Siadati Ave., Namjoo St
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.GUMS.REC.1402.612

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
Menopausal symptoms score
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Menopause Rating Scale (MRS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The fennel capsule group in this study will receive 30 mg Fennelin soft capsules (standardized to 21-27 mg of Antole) twice a day for 8 weeks orally. Fennelin soft capsule, vitamin E capsule, and placebo capsule with similar color, shape, smell, and consistency will be prepared by Kashan Barij Essan Pharmaceutical Company and provided to the researcher.
Category
Treatment - Drugs

2

Description
Intervention group: The vitamin E capsule group in this study will receive capsules containing 200 IU of vitamin E twice a day for 8 weeks orally. Fennelin soft capsule, vitamin E capsule, and placebo capsule with similar color, shape, smell, and consistency will be prepared by Kashan Barij Essan Pharmaceutical Company and provided to the researcher.
Category
Treatment - Drugs

3

Description
Control group: The placebo capsule group in this study will receive the placebo capsule orally twice a day for 8 weeks. Fennelin soft capsule, vitamin E capsule, and placebo capsule with similar color, shape, smell, and consistency will be prepared by Kashan Barij Essan Pharmaceutical Company and provided to the researcher.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra educational, remedial, and research center
Full name of responsible person
Mahshid Soltanloo
Street address
Al-Zahra educational, remedial, and research center, in front of Azodi stadium, Namjoo St. Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
41446-54829
Phone
+98 13 3336 9324
Fax
+98 13 3336 9024
Email
soltanloo.mahshid@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Farzan Ramyar
Street address
Vice Chancellor of Research and Technology of Guilan University of Medical Sciences, in front of 17 Shahrivar Hospital, Shahid Siadati St., Namjoo St., Rast, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Parvaneh Rezasoltani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahid Beheshti School of Nursing and Midwifery, ِDaneshjoo St., Shahid Beheshti Blvd., Rast, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
41469-39841
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
rezasoltani49@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Parvaneh Rezasoltani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahid Beheshti School of Nursing and Midwifery, ِDaneshjoo St., Shahid Beheshti Blvd., Rast, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
41469-39841
Phone
+98 13 3355 5056
Fax
+98 13 3355 0097
Email
rezasoltani49@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences, Shahid Beheshti School of Nursing and Midwifery
Full name of responsible person
Mahshid Soltanloo
Position
MSc Student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo St., Shahid Beheshti Blvd., Rasht, Guilan, Iran
City
Rasht
Province
Guilan
Postal code
41469-39814
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
soltanloo.mahshid@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
The results of the data and the main consequences will be shared after the study in format of knowledge translation and exchange report to the university, presentation of reports in domestic or foreign conferences and seminars and publication of article in domestic or foreign scientific-research journals.
When the data will become available and for how long
It is possible to access the study results after the defense and scientific confirmation of the dissertation In a 3 months period.
To whom data/document is available
if requested, results will be available to other academic investigators and Vice Chancellor for Research and Technology of Guilan University of Medical Sciences
Under which criteria data/document could be used
The collected data is confidential and will be kept with the researcher and will be provided to the university and researchers in the form of knowledge translation and articles. Also, if requested by the selected journal, the data will be sent in PDF format for judging and printing the article.
From where data/document is obtainable
To receive the documentation, send the email to the update manager.
What processes are involved for a request to access data/document
After the necessary checks, the desired documentary will be sent by email within one month period
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