This study is a double blind clinical trial. One hundred students with moderate or severe dysmenorrhea will match in terms of dysmenorrhea severity with Visual analogue scale and experience; age; menarche; body mass index (BMI); occupation as well as educational level of parents; and duration, interval as well as amount of bleeding. Then, they will randomly divide into 2 groups, Melissa officinalis (50 subjects) and placebo (50 subjects). In Melissa group, students will give capsules with Melissa (from Zardband Pharmaceuticals, Tehran) 3 times a day over 3 days at the onset of hemorrhage while the Placebo group will give corn starch in similar capsules with the same protocol.The capsules are similar in shape and packaging. Pain severity will evaluate with a visual analogue scale (0 to 10cm) and systemic manifestations with a multidimensional verbal scale before and during 2 consecutive menstrual cycles.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203045975N3
Registration date:2012-09-11, 1391/06/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-11, 1391/06/21
Registrant information
Name
Parvaneh Mirabi
Name of organization / entity
Islamic Azad university
Country
Iran (Islamic Republic of)
Phone
+98 24 1422 1001
Email address
p_mirabi@azu.ac.ir
Recruitment status
Recruitment complete
Funding source
The Pharmaceutical Sciences Research Center of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-05-04, 1391/02/15
Expected recruitment end date
2012-09-05, 1391/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Melissa Officinalis extract on the severity of primary dysmenorrhea and related symptoms of Islamic Azad University students in Zanjan
Public title
The effect of Melissa Officinalis extract on the severity of primary dysmenorrhea and related symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Single;18-26 years old; having moderate and severe dysmenorrhea; not having known chronic disease such as fibromyalgia ; not having vaginal discharge-dysuria- itching; regular menstration; not having history of pelvic inflammatory disease- Fibrom; Not taking medication; Not having stress condition such as parental separation - death of a family (in 2 month later).
Exclusion criteria:
Drug intolerance; Lack of proper medication or stop taking the capsules; Taking any herbal medicine in three months prior and during the intervention (except Melissa).
Age
From 18 years old to 26 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Allocation to group is based on random numbers generated by computer. Both participant and the researcher are blind to the medication becouse of the capsules are similar in shape and
packaging.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Science, near the Taleghani hospital,Tabnak St, Evin, Chamran highway, Tehran
City
Tehran
Postal code
Approval date
2011-12-25, 1390/10/04
Ethics committee reference number
89-01-86-7505-6498
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N91.0
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Dysmenorrhea
Timepoint
one cycle before and two cycles after intervention
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Severity of bleeding
Timepoint
one cycle before and two cycles after intervention.
Method of measurement
Menstrual pictogram of Campbell and Monga
Intervention groups
1
Description
In Malissa group, students will give capsules of the herb (330 mg) 3 times a day (morning, noon, night), over 3 days at the onset of hemorrhage for two consecutive menstrual cycles.
Category
Treatment - Drugs
2
Description
In placebo group students will give (330 mg) capsules contained starch 3 times a day (morning, noon, night) over 3 days at the onset of hemorrhage for two consecutive menstrual cycles.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory of Islamic Azad university at Zanjan
Full name of responsible person
Parvaneh Mirabi
Street address
Down the mountain lands, Hazrate massomeh dormitory,Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid beheshti University of Medical Sciences
Full name of responsible person
Dr Mohammad Rahmati Roodsari
Street address
Shahid beheshti University of Medical Sciences, Velenjak,Tehran
City
Tehran
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, Shahid beheshti 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
Zanjan Azad University
Full name of responsible person
Parvaneh Mirabi
Position
Faculty member
Other areas of specialty/work
Street address
Islamic Azad University, moalem street, Zanjan
City
Zanjan
Postal code
1415654141
Phone
+98 24 1422 1002
Fax
Email
parvaneh_mirabi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan, Islamic Azad University
Full name of responsible person
Parvaneh Mirabi
Position
Faculty member
Other areas of specialty/work
Street address
Islamic Azad University, moalem street, Zanjan
City
Zanjan
Postal code
Phone
+98 24 1422 1002
Fax
Email
parvaneh_mirabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan Islamic Azad University
Full name of responsible person
Parvaneh Mirabi
Position
Faculty member
Other areas of specialty/work
Street address
Department of Midwifery, Islamic Azad University, Moalem Street, Zanjan
City
Zanjan
Postal code
1415654141
Phone
+98 21 8896 9260
Fax
Email
parvaneh_mirabi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)