Effect of Chlorella supplementation on systematic symptoms and serum levels of prostaglandins, inflammatory and oxidative markers in women with primary dysmenorrhea
This study is a double blind clinical trial on 44 young girls aged 18 to 35 years in Ahvaz. In order to collect information questionnaire will be used . After obtaining informed consent, the subjects will be divided into two groups (n = 22) and control (n = 22).The intervention group will receive 5 chlorella soft gel daily one week before the start of the menstrual cycle for 2 months, the control group will receive 5 placebo soft gell. Dysmenorrhea severity will be measured using a visual analog index (Visual Analog Scale). the length of dysmenorrhea pain will be recorded as well as the number of days and number of hours per day during the cycle. The verbal multidimensional system questionnaire of dysmenorrhea will be used to search systematic symptoms. For Laboratory evaluation, blood samples will be obtained after 8-12 hours fasting, at the baseline and the end of the second cycle. Blood samples, after the 0.5 to one hour, will be centrifuged at 2000 rpm and serum will be separated and will be kept at - 70 ° C for laboratory tests .The hs-CRP PGE2, PGF2a will be measured by ELISA. MDA is measured by TBARS test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060610181N11
Registration date:2017-07-07, 1396/04/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-07, 1396/04/16
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8255
Email address
haidari-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Chlorella supplementation on systematic symptoms and serum levels of prostaglandins, inflammatory and oxidative markers in women with primary dysmenorrhea
Public title
Effect of Chlorella supplementation on Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having regular menstrual periods, moderate or severe dysmenorrheal and being single
Exclusion criteria: pain throughout the menstrual cycle, sensitivity to non-steroidal anti-inflammatory drugs, use of any antioxidant supplements in the past three months, taking oral contraceptives, reproductive disorders and a history of any abdominal or pelvic surgery
Age
From 18 years old to 35 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Ahvaz University of Medical Sciences
Street address
Khuzestan-Ahwaz
City
Ahvwaz
Postal code
61357-15794
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.AJUMS.REC.1396.159
Health conditions studied
1
Description of health condition studied
primary Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
PGE2
Timepoint
Before and after the intervention.
Method of measurement
Pg/ ml by ELISA.
2
Description
PGF2a
Timepoint
Before and after the intervention
Method of measurement
Pg/ ml by ELISA
3
Description
hs-CRP
Timepoint
Before and after the intervention
Method of measurement
μg/ml by ELISA
4
Description
MDA
Timepoint
Before and after the intervention
Method of measurement
µmol/l by TBARS
5
Description
severity of pain
Timepoint
Before and after the intervention
Method of measurement
Using Visual Analog Scale
6
Description
duration of pain
Timepoint
Before and after the intervention
Method of measurement
namber of Days and hours of pain in cycle
7
Description
Systemic symptoms
Timepoint
Before and after the intervention
Method of measurement
verbal multidimensional system questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: soft gel Chlorella , 300 mg, 5 per day for 2 months
Category
Treatment - Drugs
2
Description
Control group: placebo Soft gel , 5 per day for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh haidari
Street address
Jundishapur University of Medical Sciences, Ahvaz, Khuzestan
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz University of Medical sciences
Full name of responsible person
Dr.Makhmalzadeh
Street address
Ahvaz Golestan St., Ahwaz University of Medical Sciences
City
Ahwaz
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 of Ahvaz 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
Ahwaz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Haidari
Position
Associate Professor.Faculty member
Other areas of specialty/work
Street address
Golestan Ave.Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science Ahvaz
City
Ahwaz
Postal code
Phone
+98 61 3333 9092
Fax
Email
haidari58@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Haidari
Position
masters student
Other areas of specialty/work
Street address
Golestan Ave.Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science Ahvaz
City
Ahwaz
Postal code
Phone
+98 61 3333 9092
Fax
Email
haidari58@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Fatemeh Heidari
Position
Associate Professor
Other areas of specialty/work
Street address
Golestan Ave.Dept. of Nutrition, School of Paramedical, Ahvaz Jundishapur University of Medical Science Ahvaz
City
Ahwaz
Postal code
Phone
+98 61 3373 8330
Fax
Email
Haidari58@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)