The effect of combined Lemon balm-Nepeta menthoides and only Lemon balm on students' PMS (Premenstural Syndrom) and quality of life: a ranomized controlled trial
Objectives: This study aims to determine the efficacy of combined Lemon balm-Nepeta menthoides and only Lemon balm on PMS (Premenstural Syndrom) and quality of life among students. Design: a double blind Randomized Controlled Trial. Setting and conduct: This study will be conducted in dormiotories of Tabriz. Eligible women will be selected with convenience sampling and will be randomly assigned into 3 groups of 93 subjects with block sizes of 3 and 6. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment. Participants: 93 students with moderate or severe PMS. Interventions: First intervention group will receive Lemon balm-Nepeta menthoides Capsule, second intervention group will receive Lemon balm Capsule and third group will receive placebo Capsule. The participant will take drugs one week after the menstruation until the next menstruation bleeding for 14 days, two capsules each day for two consecutive months and they will mark severity of their symptoms in form of DRSP. Main outcome measures: Severity of Premenstural Syndrom and quality of life will be evaluated before intervention and one and two months after the intervention. Secondary outcomes include amount of menstruation bleeding, satisfaction from treatment and the frequency of adverse events that will be assessed after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031710324N17
Registration date:2014-09-28, 1393/07/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-28, 1393/07/06
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined Lemon balm-Nepeta menthoides and only Lemon balm on students' PMS (Premenstural Syndrom) and quality of life: a ranomized controlled trial
Public title
The effect of combined Lemon balm-Nepeta menthoides and only Lemon balm on student's PMS (Premenstural Syndrom) and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged 18 years and older; Having regular menstrual cycles between 21-35 days; Having a normal BMI (18.5-25) ; Having symptoms in the second half of the cycle; Having symptoms within two cycles before intervention; Having a phone number to follow up; Having tendency to participate in the study
Exclusion criteria: Having depression based on the Beck questionnaire; History of specific diseases (epilepsy, digestive, cardio - vascular, renal, neuro-endocrine) according to the self-reported; Taking an antidepressant, anticonvulsant or herbal, vitamins, hormones drugs in the past 3 months; Drinking alcohol and smoking hookah; Incidence of a stressful incident in the past 6 months: Parental divorce, Death of first degree relatives and etc.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, and East Azerbaijan
City
Tabriz
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
9313
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
Intensity of Premenstural syndrom symptoms
Timepoint
Two cycles Before intervention, 1, 2 cycles during intervention
Method of measurement
DRSP questionnaire
2
Description
Quality of life
Timepoint
Before and at the end of second cycle after intervention
Method of measurement
Quality of life questionnaire-SF-36
Secondary outcomes
1
Description
Amount of menstrual bleeding
Timepoint
Before intervention, first and second cycles during intervention
Method of measurement
Higham chart
2
Description
Statisfaction from tratment
Timepoint
After the end of intervention
Method of measurement
Questionnaire
3
Description
Frequency of adverse events
Timepoint
During intervention
Method of measurement
Checklist
Intervention groups
1
Description
The first intervention groups will receive only Lemon balm 500 mg capsules twice daily.
Category
Treatment - Drugs
2
Description
The second intervantion group will recieve Lemon balm plus Nepeta menthoides 500 mg capsules twice daily.
Category
Treatment - Drugs
3
Description
The control group will recieve 500 mg placebo capsules twice daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
dormiotories of Tabriz university of medical sciences
Full name of responsible person
Solmaz Ghanbari
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammad Reza
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Solmaz Ghanbari Homayi
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
3417174914
Phone
+98 41 1331 2679
Fax
Email
narvan_s10@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science, Nursing & Midwifery Faculty
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
34751745
Phone
+98 41 1479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)