this study was designed to investigatethe effect of Dried black seed grape on clinical and mood symptom in Students with premenstrual syndrome.sample size is 200 that will be divided into two groups (Dried black seed grape group and control ). the period of intervention is Two seven-day period that symptom will be assay in any period end by questionnaire..inclusion criteria is the risk of moderate and severe forms with age 18-35 years and exclution criteria is Failure to use 80% dried black seed grape during the intervention.The primary outcomes are Effect of phisical and mood and psychical symptom and secondry outcome are physical activity score and macronutrient intake.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015073116123N6
Registration date:2015-10-24, 1394/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-24, 1394/08/02
Registrant information
Name
Sima Jafarirad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8317
Email address
jafarirad-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Science
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dried black seed grape (vitis vinifera) on clinical and mood symptom in Students with premenstrual syndrome
Public title
Dried black seed grape(vitis vinifera) effect on premenstrual syndrom treatment process
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:age 18-35; residence in dormitory; The risk of moderate and severe forms; The lack of any specific tratment to treat PMS; Regular menstrual cycles every 24 to 35 days; Lack of reproductive system diseases; Non-marital.
Exclution criteria:Physical and mental stress in the last three months; Physical illness or medication
Consumption; A history of mental illness; Consumption of Antidepressants in recent months;
Hormone therapy; Supplements; Having a regular exercise; any specific treatment to treat PMS;
Failure to use 80% dried black seed grape during the intervention.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using simple random sampling
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Science
Street address
The Ethics Committee, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, University City, Golestan blvd.
City
Ahvaz
Postal code
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.AJUMF.REC.1394.371
Health conditions studied
1
Description of health condition studied
premenstrual syndrom
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrom
Primary outcomes
1
Description
Physical symptom score
Timepoint
Befor and first and second month end of intervention period
Method of measurement
Rossignol and Bonnlander standard questionnaire
2
Description
Mood symptom score
Timepoint
Befor and first and second month end of intervention period
Method of measurement
Rossignol and Bonnlander standard questionnaire
3
Description
Psychical symptom score
Timepoint
Befor and first and second month end of intervention period
Method of measurement
Rossignol and Bonnlander standard questionnaire
Secondary outcomes
1
Description
Physical acyivity score
Timepoint
First month and second month after intervention
Method of measurement
International physical activity questionnaire
2
Description
Macro nutrients intake
Timepoint
First month and second month after intervention
Method of measurement
3-day 24-hour recall
3
Description
Weight
Timepoint
Before and first and second end of intervention period
Method of measurement
Balance
4
Description
Height
Timepoint
Before and first and second end of intervention period
Method of measurement
Stadiometer
5
Description
waist circumference
Timepoint
Before and first and second end of intervention period
Method of measurement
Tape measure
6
Description
Hip circumference
Timepoint
Before and first and second end of intervention period
Method of measurement
Tape measure
Intervention groups
1
Description
Intervention group: Diet controlling; dried black seed grape 90 gram per day, during 7 days before menses, for 2 months.
Category
Treatment - Other
2
Description
Control group: Diet controlling, for 2 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls dormitories Ahvaz University of Medical Sciences
Full name of responsible person
Khadigeh behzadi
Street address
Student dormitory Golestan
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology,Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Nader Saki
Street address
Vice Chancellor for Research and Technology.Ahvaz Jundishapur University of Medical Sciences,University city,Golestan Blvd.
City
Ahvaz
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 and Technology,Ahvaz Jundishapur 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition and Metabolic Disease Research Center,Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr.Sima Jafarirad
Position
PHD
Other areas of specialty/work
Street address
Nutrition and Metabolic Center.Ahvaz Jundishapur University of Medical Sciences,University city,Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 3373 8317
Fax
Email
jafarirad-s@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur of Medical Science,Paramedics School.
Full name of responsible person
khadigeh Behzadi
Position
Master Student of Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences,University city,Golestan Blvd.Paramedics School
City
Ahvaz
Postal code
Phone
+98 71 3872 6062
Fax
Email
sahbehzadi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)