This study is designed as a randomized, double-blind, placebo-controlled clinical trial to investigate effect of separate and concurrent supplementation of n-3 fatty acids (FAsn-3) and Rosa damascena extract (RDE) on pain severity, systemic symptoms, menstrual duration and blood loss and appetite in girls with primary dysmenorrhea. Students of Tabriz University of medical sciences in dormitories would complete questionnaires of demographic, physical activity and menstrual parameters such as pain and systematic severity symptoms of dysmenorrhea by visual analogue scale (VAS) and multi-dimensional system (MDS). Then 120 students with moderate and severe dysmenorrhea according to inclusion and exclusion criteria will be enroll in the study after signing the informed consent sheet and randomly divided into 4 groups of 30 subjects . Group1: FAsn-3 oral capsule containing 180 mg EPA & 120 mg DHA plus placebo of RDE containing starch, Group 2: RDE oral capsule containing 800 mg rosa damascena extract plus placebo of FAsn-3 containing paraffin, Group 3: FAsn-3 oral capsule containing 180 mg EPA & 120 mg DHA plus RDE oral capsule containing 800 mg rosa damascena extract, Group 4: placebo capsules of FAsn-3 and for 2 months every day. All capsules for each of the four groups will be formed in the envelopes so that the researcher and the subjects will be unaware of the contents of the envelopes. Primary outcomes is defined as the severity of pain and systematic symptoms of dysmenorrhea, menstrual duration and blood loss by valid questionnaires is measured before and 1,2 mounths after interventions and also 3 day food record in first and last of study. Also appetite questionnaire would complete by subjects before and 1,2 mounths after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403105670N8
Registration date:2014-04-12, 1393/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-12, 1393/01/23
Registrant information
Name
Ali Tarighat-Esfanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 300 5895
Email address
tarighata@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz University of Medical Sience
Expected recruitment start date
2014-03-06, 1392/12/15
Expected recruitment end date
2014-05-05, 1393/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of separate and concurrent supplementation of n-3 fatty acids and rosa damascena extract on primary dysmenorrhea
Public title
Supplementation in dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:having dysmenorrhea in menstrual cycles in most recent years; women with moderate and severe dysmenorrhea according to VAS and MDS systems; regular menstrual cycles (21-35 day); body mass index in normal range (BMI)=18.5-24.9, Exclusion criteria: being married; history of hypersensivity for fish, seafoods and rosa damascena,; stressful event (loss of one family members, parental separation,… ); regular consumption of nutritional supplements and vitamins, oral contraceptives and other drugs; special diets like weight loss/gain diets; performing any surgery during the study; smoking and alcohol consumption; lack of complianc
Age
From 18 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Research deputy of Tabriz University of Medical Sience
Street address
Central department of Tabriz University of Medical Sience, Golgasht street, Azadi street, Tabriz
City
Tabriz
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
92212
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Dysmenorrhea pain severity
Timepoint
befor,1,2 mounth after intervention
Method of measurement
Visual Analog Scale (VAS)- 1-10 score
2
Description
Severity of systematic symptoms of dysmenorrhea
Timepoint
befor,1,2 mounth after intervention
Method of measurement
Visual Analoge Scale (VAS)- 1-10 score
3
Description
Menstrual duration
Timepoint
before and after of intervention
Method of measurement
Complete of questionnare
4
Description
Amount of blood loss
Timepoint
before and after of intervention
Method of measurement
Complete of questionnare
5
Description
Appetite
Timepoint
befor,1,2 mounth after intervention
Method of measurement
Visual Analoge Scale (VAS)- 1-100 score
6
Description
Calorie and macronutrient intake
Timepoint
before and after of intervention
Method of measurement
Food record for 3 day
Secondary outcomes
1
Description
Body weight
Timepoint
before and after of intervention
Method of measurement
Measurment of weight by scale (kg)
2
Description
Waist circumference
Timepoint
before and after of intervention
Method of measurement
meter (cm)
Intervention groups
1
Description
Control Group: placeboes of FAsn-3 and rosa damascena extract every day for 2 mounths
Category
Placebo
2
Description
Intervention group 2: oral capsul containing of 800mg rosa damscena extract and placebo of FAsn-3 containing paraffin every day for two mounths.
Category
Other
3
Description
Intervention group 1: FAsn-3 oral capsule.1 g containing 180 mg EPA &120mg DHA and placebo of rosa damascena extract containing starch every day for two mounths
Category
Other
4
Description
Intervention group3: FAsn-3 oral capsule,1g containing 180 mg EPA and 120 mg DHA and oral capsule containing 800 mg rosa damascena extract every day for two mounths
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitories of Tabriz University of Medical Sciences
Full name of responsible person
Soheila Davaneghi
Street address
Nutrition faculty of Tabriz University of Medical Sience, Golgasht street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sience
Full name of responsible person
Dr Bahram Pourghasem Gagari
Street address
Central department of Tabriz University of Medical Sience, Golgasht street, Azadi street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz University of Medical Sience
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Dr. Ali Tarighat-Esfanjani
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Science, Faculty of Nutrition, Golgasht Street, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 7583
Fax
+98 41 1334 0634
Email
tarighata@tbzmed.ac.ir
Web page address
zabarjad.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)