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Interactive effect of Plyometric (Elastic) Exercises with Fennel Extract and Calcium-vitamin D supplementation on Premenstrual Syndrome in non-athletic girls

Protocol summary

Study aim
Determination of interactive effect of Plyometric (Elastic) Exercises with Fennel Extract and Calcium-vitamin D supplementation on Premenstrual Syndrome in non-athletic girls
Design
The practical and randomized study with pre-test/post-test six groups and control design is conducted on 70 non-athletic girls for 8 weeks. Random number table will be used in this study for tasks such as selected random samples in groups.
Settings and conduct
This study is conducted on 70 non-athlete female students who has been diagnosed with premenstrual syndrome for 8 weeks. After necessary explanations, they are assigned into seven experimental groups. Participants are investigated pre and post-intervention, using a premenstrual symptoms screening tool, Data analysis is performed by SPSS-20 software, One way ANOVA, ANCOVA and post hoc Tukey test are used to compare the obtained data (p≤0.05).
Participants/Inclusion and exclusion criteria
1. The non-athlete female students who are inclined participation and had been diagnosed with premenstrual syndrome by Premenstrual Symptoms Screening Tool (PSST), they will be inter in this study. 2. The female students who have had chronic and pelvic inflammatory disease, used special drugs and influenced stress factors, they won’t be inter in this study.
Intervention groups
The effect of Elastic exercise, Fennel extract, calcium-vitamin D supplementation, interaction effects of exercise and Fennel extract, exercise and calcium-vitamin D supplementation, exercise, Fennel extract and calcium-vitamin D supplementation with control group (without intervention) are studied on Premenstrual Syndrome in non-athletic girls for 8 weeks.
Main outcome variables
Mean scores of mood; behavioral and physical symptoms of premenstrual syndrome by using premenstrual symptoms screening tool (PSST)

General information

Reason for update
Acronym
PMSS
IRCT registration information
IRCT registration number: IRCT20201116049412N1
Registration date: 2020-12-20, 1399/09/30
Registration timing: prospective

Last update: 2020-12-20, 1399/09/30
Update count: 0
Registration date
2020-12-20, 1399/09/30
Registrant information
Name
Forouzan Esmaielzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3820 4055
Email address
f.esmaielzadeh@miau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Interactive effect of Plyometric (Elastic) Exercises with Fennel Extract and Calcium-vitamin D supplementation on Premenstrual Syndrome in non-athletic girls
Public title
The effect of Elastic Exercises, Fennel Extract and Calcium-vitamin D supplementation in treatment of Premenstrual Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The female students who aren't athletic. The female students who be inclined participation in this study. The non-athlete female students who had been diagnosed with premenstrual syndrome by Premenstrual Symptoms Screening Tool (PSST) .
Exclusion criteria:
The female students who have had chronic and pelvic inflammatory disease in previous record. The female students who have used special drugs. The female students who have influenced stress factors.
Age
From 15 years old to 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table will be used in this study for tasks such as selected random samples in groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
7th floor, Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences, Zand St.
City
ُShiraz
Province
Fars
Postal code
7176684895
Approval date
2020-11-02, 1399/08/12
Ethics committee reference number
IR.SUMS.REHAB.REC.1399.037

Health conditions studied

1

Description of health condition studied
Premenstrual Syndrome (PMS)
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Mean scores of mood – behavioral and physical symptoms of premenstrual syndrome by using premenstrual symptoms screening tool (PSST)
Timepoint
At first study and 8 weeks after beginning of elastic exercises with fennel extract and vitamin D (pre and post-intervention)
Method of measurement
Premenstrual symptoms screening tool

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Control group hasn’t any intervention.
Category
Treatment - Other

2

Description
Intervention group 2: Elastic exercise is performed 3 sessions (45 minute) a week for 8 weeks.
Category
Treatment - Other

3

Description
Intervention group 3: Fennel extract (2% Fennelin Oral Drop (15.5 mg/ml anethole), Barij Essence Pharmaceutical company) is used 2 times a day (30 drops every 12 hours) for 8 weeks.
Category
Treatment - Drugs

4

Description
Intervention group 4: Calcium-vitamin D supplementation (Calcium-vitamin D pills (containing 500 mg calcium carbonate plus 200 IU Vitamin D3 or cholecalciferol), Iran Darou Pharmaceutical Company) is used twice a day (1000 mg every 12 hours) for 8 weeks.
Category
Treatment - Drugs

5

Description
Intervention group 5: Elastic exercise and Fennel extract are used (similar to post-interventions) for 8 weeks.
Category
Treatment - Drugs

6

Description
Intervention group 6: Elastic exercise and calcium-vitamin D supplementation are used (similar to post-interventions) for 8 weeks.
Category
Treatment - Drugs

7

Description
Intervention group 7: Elastic exercise, Fennel extract and calcium-vitamin D supplementation are used (similar to post-interventions) for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
High School in the City of Shiraz Female (Rah Sadat industrial school)
Full name of responsible person
Schoolmaster
Street address
Next to the 13th Alley, in front of registry office, Edalat Blvd.
City
Shiraz
Province
Fars
Postal code
7176684895
Phone
+98 71 3824 5024
Email
forouzanesmaielzadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
7th floor, Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
7176684895
Phone
+98 71 3242 4127
Fax
+98 71 3242 6729
Email
Ghasemiy@sums.ac.ir
Web page address
https://ethics.research.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Forouzan Esmaielzadeh
Position
assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Animal Breeding
Street address
No. 135, 8th Alley, Edalat Ave.
City
Shiraz
Province
Fars
Postal code
7176684895
Phone
+98 71 3820 4055
Email
forouzanesmaielzadeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Kasraeian
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal-fetal Medicine Research Center, Shiraz University of Medical Sciences.
City
Shiraz
Province
Fars
Postal code
7176684895
Phone
+98 71 3233 5852
Fax
+98 71 3233 2365
Email
maryamkasraeian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Forouzan Esmaielzadeh
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Animal Breeding
Street address
Islamic Azad University, Marvdasht Branch, Persepolis, 3 km of Marvdasht Blvd.
City
Marvdasht
Province
Fars
Postal code
7371113119
Phone
+98 71 43311150 to 9
Fax
+98 71 4331 1172
Email
f.esmaielzadeh@miau.ac.ir
Web page address
http://www.miau.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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