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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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
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

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

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
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Data was analyzed by SPSS (v. 11.5) and p<0.05 was considered statistically significant

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 4809 0
Iran, Islamic Republic Of
State/province [1] 4809 0

Funding & Sponsors
Funding source category [1] 286594 0
Name [1] 286594 0
Moalem High School
Address [1] 286594 0
Moalem High School . Pakdasht city,Tehran,Iran
Country [1] 286594 0
Iran, Islamic Republic Of
Primary sponsor type
Hassan Pazoki
no 11 Karobi Alley, norallah pazoki street,shohadaye gomnam square . Pakdasht city,Tehran,Iran
postcode :3391915486
Iran, Islamic Republic Of
Secondary sponsor category [1] 285375 0
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
Ethics committee country [1] 288666 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 288666 0
Approval date [1] 288666 0
Ethics approval number [1] 288666 0

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

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
Fax 37194 0
Email 37194 0
Contact person for public queries
Name 37195 0
Mr 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
Fax 37195 0
Email 37195 0
Contact person for scientific queries
Name 37196 0
Dr Farah Farokhi
Address 37196 0
department of Biology, Faculty of Science, Urmia University, West Azerbaijan
Country 37196 0
Iran, Islamic Republic Of
Phone 37196 0
Fax 37196 0
Email 37196 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary