Comparison of the effectiveness of Vitagnos, Gabapentin and Paroxetine on the early complications of menopause in women: a double-blind clinical trial.
Comparison of the effectiveness of Vitagnos, Gabapentin and Paroxetine on the early complications of menopause in women
Design
Control-controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 90 patients used the Excel software rand function for randomization.
Settings and conduct
This project was carried out at Shahid Sadoughi Hospital in Yazd. Patients in three groups of 30 people for 8 weeks use 2 Vitagnos tablets or 1 Paroxetine tablet or Gabapentin capsule daily.
Participants/Inclusion and exclusion criteria
Patients who have been amenorrhoeic for at least one year and have hot flashes 3 or more times in 24 hours. They do not have an uncontrolled underlying disease and do not use drugs containing estrogenic or pseudo-estrogen compounds.
Intervention groups
In order to evaluate the effectiveness of Vitagenus in the complications of early menopause, a group of 30 people is given Vitagenus, a group of 30 people is given paroxetine and a group of 30 people is given gabapentin.
Main outcome variables
Severity of hot flashes,
The frequency of hot flashes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N16
Registration date:2023-10-28, 1402/08/06
Registration timing:retrospective
Last update:2023-10-28, 1402/08/06
Update count:0
Registration date
2023-10-28, 1402/08/06
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Vitagnos, Gabapentin and Paroxetine on the early complications of menopause in women: a double-blind clinical trial.
Public title
The effectiveness of Vitagnos, Gabapentin and Paroxetine on early menopause complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45 to 60 years
Amenorrhea for at least 12 months
At least 3 hot flushes in 24 hours
Exclusion criteria:
Women with abnormal menopause
Patients with chronic diseases (thyroid disease, psychosomatic disease, pheochromocytoma, carcinoid, leukemia, cancer and other known systemic diseases such as hypertension, diabetes, heart diseases)
Consumption of hormones and supplements (containing estrogen-like compounds such as soy)
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Patients were randomly assigned to two groups by using Excel software rand function.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients, the clinical caregiver and the outcome assessor were not aware of the type of medication the patients received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2017-11-29, 1396/09/08
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.209
Health conditions studied
1
Description of health condition studied
early complications of menopause
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Menopause symptoms
Timepoint
Week 0, 4 and 8
Method of measurement
based on Kupperman Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients suffering from early complications of menopause use gabapentin 100 mg orally daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Patients suffering from early complications of menopause use vitagnos orally twice a day for 8 weeks.
Category
Treatment - Drugs
3
Description
Control group: Patients suffering from early complications of menopause use paroxetine 20 mg orally daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Mojgan Karimi Zarchi
Street address
Ibn Sina Street, Shahid Ghandi Boulevard, Safaieh, Yazd.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Fax
Email
sadoghi-hospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghouei
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2150
Email
abargouei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.