Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome in comparison with placebo
Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome in comparison with placebo
Design
Phase 3 randomized triple-blind clinical trial of three witnessed blind groups, including an intervention group and a placebo group
Settings and conduct
The personal form and PSST will be filled in by the students of Mashhad dormitories.qualified individuals by entry and non-entry criteria will complete the DRSP for two months for a definitive diagnosis of PMS, then 80 individuals will be selected and complete the Quality of Life and Temperament Questionnaire. before the intervention, the samples were statistically analyzed and randomly divided into two groups by software. The test group will receive Echium and fennel capsules, and the control receive placebo for 2 menstrual cycles. during which the DRSP is completed. capsules are distributed in the same form, package and number.
Participants/Inclusion and exclusion criteria
Inclusion:
Age 18 to 35 years
Single,
Regular menstruation for 6 months
Bleeding 3 to 9 and intervals 24 to 35 days
Complete the conscious consent form
minimum score of 19 from PSST
non-Inclusion:
History of mental illness, surgery, estrogen-related cancers, thyroid, liver and kidney disease, diabetes and hypertension
Death of a loved one in the last six months
use of anti-anxiety and anti-depressant, estrogen and progesterone drugs in the last three months
Taking herbal, vitamin and mineral supplements over the past month
allergy to Echium and fennel
Intervention groups
Intervention: capsules (with a dose of 2 grams of Echium and 1 gram of fennel per day),in the second two weeks, In two consecutive cycles.
placebo: capsule containing starch
Main outcome variables
The rate of changes in the severity of symptoms of PMS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200530047600N1
Registration date:2020-07-18, 1399/04/28
Registration timing:prospective
Last update:2020-07-18, 1399/04/28
Update count:1
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
Simin sadat Motevalli Haghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3891 0394
Email address
motevalihs961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome in comparison with placebo
Public title
Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome in comparison with placebo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years
Single,
Regular menstruation for the past 6 months,
Bleeding period 3 to 9 days and two bleeding intervals 24 to 35 days,
Complete the conscious consent form
Get a minimum score of 19 from the PSST questionnaire
Exclusion criteria:
History of mental illness, surgery, estrogen-related cancers, thyroid, liver and kidney disease, diabetes and hypertension
Death of a loved one in the last six months
The use of anti-anxiety and anti-depressant drugs in the last three months,
The use of estrogen and progesterone medications in the last three months,
Taking herbal medicines and vitamin and mineral supplements over the past month,
History of allergy to Echium and fennel
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Unit: Individual
It is not stratified
Tools: PASS statistical software
Regarding concealment: A person outside the design will prepare sealed envelopes based on the random allocation sequence created and provide them to the executors.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The same capsules, with the same number, are placed in similar enveloped envelopes (from 1 to 80) based on a random assignment list by a person outside the research design.The study subjects receive the capsules monthly and in envelopes with the code. Participants, researchers, data evaluators, and data analysts are unaware of how the code is assigned.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Mashhad University of Medical Sciences
Street address
Ethics Committee in Research, Central University Building, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.MUMS.REC.1399.276
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
The rate of change in the severity of symptoms of premenstrual syndrome
Timepoint
Before the intervention, the first menstrual cycle after the intervention, the second menstrual cycle after the intervention
Method of measurement
Daily Record of Severity of Problems (DRSP)
Secondary outcomes
1
Description
The relationship between general temperament and the severity of symptoms
Timepoint
At the beginning of the study
Method of measurement
Daily Record of Severity of Problems (DRSP), Mojahedi Mizaj Questionnaire(MMQ)
2
Description
Changes in the quality of life in the intervention and control groups
Timepoint
Before and after the intervention
Method of measurement
Short-Form Health Survey questionnaire(SF-36)
3
Description
possible side effects
Timepoint
During the intervention
Method of measurement
Patient report
4
Description
The relationship between general temperament and the type of symptoms
Timepoint
At the beginning of the study
Method of measurement
Daily Record of Severity of Problems (DRSP), Mojahedi Mizaj Questionnaire(MMQ)
Intervention groups
1
Description
Intervention group: The test group received oral capsules containing Echium and fennel at a dose of 2 grams of Echium and 1 gram of fennel fruit (Ground and granulated) during the day, fasting in the morning and at night with a glass of lukewarm water for the second two weeks of Cycle in two consecutive cycles.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive a placebo capsule containing starch with the conditions of the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Medical Sciences Dormitory
Full name of responsible person
Simin Sadat Motevalli Haghi
Street address
Campus of Medical Sciences Dormitories, Bahonar St., Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3891 0394
Email
motevalihs961@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ferdowsi University Dormitory Campus
Full name of responsible person
Simin Sadat Motevalli Haghi
Street address
Ferdowsi University Dormitory Campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3891 0394
Email
motevalihs961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
دکتر محسن تفقدی
Street address
University Street, next to Hoveyzeh Cinema, Ghorashi Building, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Simin Sadat Motevalli Haghi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3891 0394
Email
motevalihs961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Maliha Motusalian
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Email
MotavasselianM@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Simin Sadat Motevalli Haghi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3891 0394
Email
motevalihs961@mums.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