The effect of garlic tablet on mood and physical disorder in premenstrual period
Design
After completion of the initial questionnaire, the dormitory students completed the PSST questionnaire and their satisfaction. This study is a double-blind randomized clinical trial with parallel groups. The appropriate sample size (120 people) is grouped into two groups based on randomly generated computer sequences and each one receives a code.
Settings and conduct
Investigator and participant are unaware of drug content.
Drugs are required for three daily cycles, a PSST questionnaire, and a form of side effects in the first study. Each of these three is given to each sample in Ahmadi's health center, and they are asked to complete each cycle on the seventh to tenth day of each cycle.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Ready to participate in the study
Women 18 to 35 years old
Regular menstruation with cycle 21 to 35 days
Medium PMS in questionnaire
Non-inclusion criteria:
Pregnancy and lactation
Physical illnesses like thyroid disease or anemia
Mental illness with medication
Use of hormones, cigarettes, alcohol, anticoagulants and supplements
Stressful accidents from three months ago
PMS treatment since two months ago
Intervention groups
Intervention group: 400 milligrams of garlic
Control group: Placebo tablets containing starch
Main outcome variables
Premenstrual syndrome
Age
Height
Weight
BMI
Anger
Anxiety
Crying
Depressed mood
Reducing interest in job activity
Reducing interest in home-based activity
Reducing interest in social activity
Difficulty concentrating
Fatigue
Overeating
insomnia
Sweaty
Feelings
Breast pain
Headache
Dizziness
Nausea
Flatulence
Weight Gain
The amount of bleeding
Duration of bleeding
Cycle length
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180311039038N1
Registration date:2018-03-25, 1397/01/05
Registration timing:prospective
Last update:2018-03-25, 1397/01/05
Update count:0
Registration date
2018-03-25, 1397/01/05
Registrant information
Name
fatemeh jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4426 8960
Email address
f_jafari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of garlic tablet on mood and physical disorder in premenstrual period
Public title
The effect of garlic on the treatment of premenstrual dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ready to participate in the study
Women aged 18 to 35 years old
Regular menstruation with a length of 21 to 35 days from six months ago
Proof of PMS moderate in the questionnaire
Exclusion criteria:
Pregnancy and lactation
Physical illnesses like thyroid disease or anemia in history or paraclinic
mental illness with taking medication
Use of hormonal drugs, cigarettes, alcohol, anticoagulants and supplements
Stressful events from the three months before the study
Drug use for PMS two months before the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are grouped into two groups A and B, based on random sequences generated by computer software. Each patient receives a code.One drug group is being treated and one placebo group
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients receive encoded medication without knowing that they are in the intervention or control group.The researcher does not know the pharmaceutical content of the samples
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Room 605, 6th floor, central building of Tehran University of Medical Sciences, Keshavarz Blvd and Ghodss St., Tehran
City
Tehran
Province
Tehran
Postal code
1463815763
Approval date
2018-02-27, 1396/12/08
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4670
Health conditions studied
1
Description of health condition studied
Premenstrual dysfunction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of garlic on premenstrual dysfunction
Timepoint
At the beginning of the study and at the beginning of each cycle after the intervention for three cycles of menstruation
Method of measurement
Questionnaire
Secondary outcomes
1
Description
The effect of garlic on menstrual pattern
Timepoint
ََAt the beginning of the study and at the start of each cycle after the intervention for three menstrual cycles
Method of measurement
Questionnaire
Intervention groups
1
Description
Category
empty
2
Description
Intervention group: Garlic Tablets is 400 mg of Dineh Pharmaceutical Company, which is available in Iran's pharmaceutical market and consumes a daily amount of three consecutive cycles.
Category
Treatment - Other
3
Description
Control group: Placebo pill contains starch powder that is similar in appearance to the garlic pill and is prepared by the same company and consumed in the same way.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Student Dormitory in Nasibe in Tehran
Full name of responsible person
Marzieh Baghestani
Street address
Nasiba Pardis in Tehran, Nsiba St، Blvd. Marzardan, Tehran
City
Tehran
Province
Tehran
Postal code
1463773111
Phone
+98 21 4426 4157
Email
dr.fjafari52@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraeian
Street address
Central Building of Tehran University of Medical Sciences, Keshavarz Blvd. and Qods St., Tehran
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8163 3600
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Jafari
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Health Center Ahmadiye, Northern sarparast St, Taleghani St., Tehran
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 218897652730
Email
f_jafari@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Jafari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Health Center Ahmadiye, Northern Head office, Taleghani St., Tehran
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 218897652730
Email
f_jafari@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Jafari
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Health Center Ahmadiye, Northern Head office, Taleghani St., Tehran
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 218897652730
Email
f_jafari@razi.tums.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