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Trial registered on ANZCTR


Registration number
ACTRN12613000088741
Ethics application status
Not yet submitted
Date submitted
19/01/2013
Date registered
23/01/2013
Date last updated
23/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing the Effects of Aerobic Exercise and Fennel (Foeniculum vulgare) on Pre-menstrual Syndrome in High School Young Girls
Scientific title
effectiveness of Fennel and Aerobic Exercise each or together on Pre-menstrual Syndrome (PMS) on Young Girls Aged 16-18
Secondary ID [1] 281807 0
Nil
Universal Trial Number (UTN)
U1111-1138-6300
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre-menstrual syndrome (PMS) symptoms such as irritability 288143 0
mood swings 288144 0
anxiety 288145 0
depression 288146 0
breast tenderness, 288147 0
bloating 288148 0
headache 288149 0
Condition category
Condition code
Reproductive Health and Childbirth 288516 288516 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1: use of Fennel (Foeniculum vulgare) as a herbal medicine ,the amount of the given fennel extracts was 30 drops, every 8 hours, every day from 3 days before until 3 days after the onset of menstrual bleeding

ARM2: use of regular Aerobic exercise ,60 minutes ,3 time a week, every other day, 8 weeks,
the exercise was 1 hour, include 15 minutes warming(Stretching Exercises), 15 minutes aerobic exercise,15 minutes running and 15 minutes Smooth running for ending ,the aim of this exercise is to gain Required heart rate (MHR) and for this ,first and second weeks our exercise pressure was 50% of maximum hart rat and third and fourth weeks 60%,fifth and sixth weeks 70% and two last weeks 80% of maximum heart rate. and they have supervised by a trained sport physiologist.
Intervention code [1] 286354 0
Treatment: Other
Intervention code [2] 286355 0
Prevention
Comparator / control treatment

ARM3:Our control group didn’t receive Fennel Extract and Aerobic Exercise but they have the same problem as other groups have
Control group
Active

Outcomes
Primary outcome [1] 288673 0
PMS symptom reduced as assessed by Daily Record of Severity of Problem (DRSP)
Timepoint [1] 288673 0
3 days before until 3 days after the onset of menstrual bleeding (daily)
Primary outcome [2] 288674 0
mean Beck PMS symptom score
Timepoint [2] 288674 0
menstrual before the intervention and 2 menstrual cycle after intervention .(daily)
Secondary outcome [1] 300738 0
depression and pain during menstrual as assessed by Daily Record of Severity of Problem (DRSP)

Timepoint [1] 300738 0
first menstrual cycle after intervention

Eligibility
Key inclusion criteria
200 students were requested to fill pre-menstrual recognition form (Aganov)and then 36 students with moderate to severe PMS were selected
Minimum age
16 Years
Maximum age
18 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
in case of physical problem to do Aerobic exercise for exercise group or digestive problem or any allergy to Fennel extract for Fennel group

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data was analyzed by SPSS (v. 11.5) and p<0.05 was considered statistically significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
1/08/2011
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 4809 0
Iran, Islamic Republic Of
State/province [1] 4809 0
Tehran

Funding & Sponsors
Funding source category [1] 286594 0
Other
Name [1] 286594 0
Moalem High School
Country [1] 286594 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Hassan Pazoki
Address
no 11 Karobi Alley, norallah pazoki street,shohadaye gomnam square . Pakdasht city,Tehran,Iran
postcode :3391915486
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 285375 0
Individual
Name [1] 285375 0
Bolouri Golbano
Address [1] 285375 0
no 17,Navabe Safavi Street, Garmsar, Semnan , Iran
postcode: 3581777535
Country [1] 285375 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288666 0
Urmia University
Ethics committee address [1] 288666 0
Urmia University, West Azerbaijan
postcode:57153-165
Ethics committee country [1] 288666 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 288666 0
07/01/2013
Approval date [1] 288666 0
Ethics approval number [1] 288666 0

Summary
Brief summary
the purpose of this study is to evaluated whether herbal medicine such as Fennel and aerobic exercise could reduce the severity of PMS symptom or not
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37194 0
Mr Hassan Pazoki
Address 37194 0
no 11 Karobi Alley. Noralah Pazoki Street,Shohadaye Gomnam Square,Pakdasht City, Tehran
postcode: 3391915486
Country 37194 0
Iran, Islamic Republic Of
Phone 37194 0
+989123148931
Fax 37194 0
Email 37194 0
hasan_fsh33@yahoo.com
Contact person for public queries
Name 37195 0
Hassan Pazoki
Address 37195 0
no 11 Karobi Alley. Noralah Pazoki Street,Shohadaye Gomnam Square,Pakdasht City, Tehran
postcode: 3391915486
Country 37195 0
Iran, Islamic Republic Of
Phone 37195 0
+989123148931
Fax 37195 0
Email 37195 0
hasan_fsh33@yahoo.com
Contact person for scientific queries
Name 37196 0
Farah Farokhi
Address 37196 0
department of Biology, Faculty of Science, Urmia University, West Azerbaijan
postcode:57139-17493
Country 37196 0
Iran, Islamic Republic Of
Phone 37196 0
+989143460715
Fax 37196 0
Email 37196 0
f.farokhi@urmia.ac.ir

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.