Protocol summary

Summary
The purpose of this study was to compare the Effect of Fennel and Pilates on the Pre-Menstrual Syndrome in non-athletic girls. Methods: This quasi-experimental study was conducted on 40 non-athlete female students. They aged 18-23 year and had been diagnosed with PMS. The participants were assigned to four experimental groups (Fennel, Pilate, Fennel and Pilate) and a control group. All the trainings were performed about 4 weeks and every week there were 3 sessions of training. Students were advised to use the fennel extract, 2 times a day for a Month. The participants were investigated during their first period (pre-test) and the second (post-test), using a premenstrual symptoms screening tool (psst). Conclusion: our findings indicate that consumption this fennel extract with Pilates exercise improves the severity of pms symptom among the participants of this Study Essential Key: premenstrual syndrome, Pilates, fennel the plant

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015011520465N1
Registration date: 2015-01-22, 1393/11/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-22, 1393/11/02
Registrant information
Name
Fatemeh Omidali
Name of organization / entity
University of Ayatollah Boroujerdi
Country
Iran (Islamic Republic of)
Phone
+98 66 4246 8320
Email address
f.omidali@abru.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Ayatollah Boroujerdi
Expected recruitment start date
2014-09-24, 1393/07/02
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pilates and consumption relationship of fennel extract and the symptoms of PMS girls non athletic
Public title
The Effect of Fennel and Pilates the Pre-Menstrual Syndrome in non-athletic girls
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: PMS symptoms; lack of medication; non-athletes Exclusion criteria: disease; lack of cooperation
Age
From 18 years old to 23 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 260
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Ayatollah Boroujerdi
Street address
3km Khorramabad Bourujerd
City
Bourujerd
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
93-پ10

Health conditions studied

1

Description of health condition studied
Pilates and consumer relationship fennel extract on symptoms of premenstrual syndrome in girls non-athletes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mood and behavioral symptoms
Timepoint
Pretest- Post test
Method of measurement
Premenstrual Symptoms screening of questionnaires psst (Iranian species)

2

Description
Physical symptoms
Timepoint
Before and after the test
Method of measurement
Premenstrual Symptoms screening of questionnaires

3

Description
Physical and psychological symptoms of PMS the impact on the lives of patients affected by
Timepoint
Before and after the test
Method of measurement
Premenstrual Symptoms screening of questionnaires

Secondary outcomes

1

Description
Symptoms of PMS
Timepoint
Before and After test
Method of measurement
Premenstrual Symptoms screening of questionnaires psst (Iranian species)

Intervention groups

1

Description
Intervention group: Pilates exercises for 4 weeks, 3 times a week for 45 minutes In each session
Category
Lifestyle

2

Description
Intervention group: Pilates exercises for 4 weeks, 3 times a week for 45 minutes In each session؛ Students training along with fennel extract, 2 times a day for a month and consumed
Category
Lifestyle

3

Description
3 Intervention group: Students fennel extract 2 times a day for a month and consumed
Category
Treatment - Drugs

4

Description
Control group: not done any exercise and do not use drugs
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Ayatollah Boroujerdi
Full name of responsible person
Fatemeh Omidali
Street address
3km Khorramabad Bourujerd
City
Bourujerd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Ayatollah Boroujerdi
Full name of responsible person
Fatemeh Omidali
Street address
3km Khorramabad Bourujerd
City
Bourujerd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Ayatollah Boroujerdi
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
University of Ayatollah Boroujerdi
Full name of responsible person
Fatemeh Omidali
Position
Master of Science
Other areas of specialty/work
Street address
3km Khorramabad Bourujerd
City
Bourujerd
Postal code
Phone
+98 66 4246 8320
Fax
Email
f.omidali@abru.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Ayatollah Boroujerdi
Full name of responsible person
Fatemeh Omidali
Position
Master of Science
Other areas of specialty/work
Street address
3km Khorramabad Borujerd
City
Bourujerd
Postal code
Phone
+98 66 4246 8320
Fax
Email
f.omidali@aru.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Ayatollah Boroujerdi
Full name of responsible person
Fatemeh Omidali
Position
Master of Science
Other areas of specialty/work
Street address
3km Khorramabad
City
Bourujerd
Postal code
Phone
+98 66 4246 8320
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...