The purpose of this study is to investigate the effect of aerobic exercise and consumption of curcumin on physiological parameters of premenstrual syndrome in young non athletes women. For this purpose ,44 women with moderate to severe premenstrual syndrome selected and randomly assigned to 4 groups of 11 subject: aerobic training, curcumin, curcumin + aerobic training and control group. The instrument was Dickerson questionnaire (to diagnose premenstrual syndrome) and a questionnaire containing demographic and social information of samples. exercise Group did aerobic exercise for 12 weeks (3 times a week for 1 gour) with 50 to 60% of maximum heart rate .curcumin group used 100mg curcumin twice a day for 3 months(A week before menstruation till 3 days after onset of bleeding). Combined group did both of these interventions at the same time and the control group as well as the curcumin group used 100mg corn starch twice a day as placebo that have the same color as the main drug for 3 months(A week before menstruation till 3 days after onset of bleeding). In this study, curcumin supplements and corn powder (placebo) capsules were placed in the same shape and size capsules . The capsules was labeled 1 and 2 and gave to subjects by study investigator. Researcher and the subjects were unaware from the content of capsules. After analyzing the data, capsules contents will Inquiry from pharmacist. Data will be analyzed by using descriptive and inferential statistics at the significant level 0/05.
General information
Acronym
PMS
IRCT registration information
IRCT registration number:IRCT2017010331745N1
Registration date:2017-04-22, 1396/02/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-22, 1396/02/02
Registrant information
Name
Ladan Zoodfekr
Name of organization / entity
Islamic Azad University Central Tehran Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 8807 4870
Email address
ladanzoodfekr@gmail.com
Recruitment status
Recruitment complete
Funding source
In this study, the researcher does not have any funds
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aerobic exercise and consumption of curcumin on physiological parameters and edema in 18-35 years old women with premenstrual syndrome
Public title
Effect of aerobic exercise and consumption of curcumin on Premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-35 year old; Having regular menstrual cycles ( 28-35 days); Suffering from moderate or severe PMS and at least have five physical symptoms based on Dickerson questionnaire; Do not Consumption effective drugs (chemical or herbal) on the premenstrual syndrome in the recent quarter. Exclusion criteria: physical and mental illnesses like diabetes, biliary or kidney disease, epilepsy, thyroid disease or other metabolic disorders; Consumption hormonal, anti convulsants and anti depression drugs; Smoking and drug abuse.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Sport Sciences Research Institute of Iran
Street address
No 3, 5th Dead End, Miremad St, Motahhari St, Tehran, Tehran Province
City
Tehran
Postal code
Approval date
2016-05-21, 1395/03/01
Ethics committee reference number
IR.SSRI.REC.1395.124
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
physical Indicators of Premenstrual syndrome
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
2
Description
emotional Indicators of Premenstrual syndrome
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
3
Description
psychological Indicators of Premenstrual syndrome
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
4
Description
prostaglandin E2
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
5
Description
estrogen
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
6
Description
Progesteron
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
7
Description
Prolactin
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
8
Description
Blood suger
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
9
Description
Edema
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
Secondary outcomes
1
Description
physical Indicators of Premenstrual syndrome
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
2
Description
emotional Indicators of Premenstrual syndrome
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
3
Description
prolactin
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
4
Description
progesteron
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
5
Description
psychological Indicators of Premenstrual syndrome
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
6
Description
blood suger
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
7
Description
esterogen
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
8
Description
prostaglandin E2
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
9
Description
Edema
Timepoint
before intervention and 3 months after intervention
Method of measurement
Dickerson standard questionnaire , blood Measurements
Intervention groups
1
Description
curcumin 100 mg oral capsules, twice a day (from a week before mense till 3 days after bleeding)for 3 months + aerobic exercise with 50-60 % maximum heart rate, 3 times a week, 1 hour each day, for 3 months
Category
Treatment - Drugs
2
Description
curcumin
100 mg oral capsules
twice a day(from a week before mense till 3 days after bleeding)
for 3 months
Category
Treatment - Drugs
3
Description
Corn starch
100 mg oral capsules
twice a day(from a week before mense till 3 days after bleeding)
for 3 months
Category
Placebo
4
Description
Do aerobic exercise with 50-60 % maximum heart rate, 3 times a week, 1 hour daily, for 3 months
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Alzahra hospital, East Azarbayjan province
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Islamic Azad University Central Tehran Branch
Full name of responsible person
Ali Niyazi
Street address
Forsate shirazi St, North Eskandari St, Azadi St, 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 of Islamic Azad University Central Tehran Branch
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
Islamic Azad University
Full name of responsible person
Ladan Zoodfekr
Position
PHD student
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Azad University tehran Central Branch, sanat square, Tehran
City
Tehran
Postal code
Phone
+98 21 8807 4870
Fax
Email
ladan_zoodfekr@yahoo.com, ladanzoodfekr@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad univrsiy
Full name of responsible person
Ladan Zoodfekr
Position
PHD student
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Azad University tehran Central Branch, sanat square, Tehran
City
Tehran
Postal code
Phone
+98 21 8807 4870
Fax
Email
ladan_zoodfekr@yahoo.com, ladanzoodfekr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic azad university
Full name of responsible person
Ladan Zoodfekr
Position
PHD student
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Azad University tehran Central Branch, sanat square, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
ladan_zoodfekr@email.com, ladanzoodfekr@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)