Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000758808
Ethics application status
Approved
Date submitted
9/07/2012
Date registered
17/07/2012
Date last updated
17/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of Japanese Acupressure “Shiatsu” on Cycle Rhythm in Amenorrheic Athletes.
Scientific title
Impact of Japanese Acupressure “Shiatsu” on restoration of menses in Amenorrheic Athletes
Secondary ID [1] 280840 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
amenorrhea 286860 0
Condition category
Condition code
Reproductive Health and Childbirth 287183 287183 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
acupressure is finger pressure conducted by professional therapist on certain points on abdomen and back according to Chinese Meridian concept for 45minutes session administered 3 times per week for 3 months, and twice weekly for 3 more months.
Intervention code [1] 285229 0
Treatment: Other
Comparator / control treatment
there is control group receiving no treatment.
Control group
Active

Outcomes
Primary outcome [1] 287478 0
Participant diary about time to first menstrual period and subsequent periods thereafter.
Timepoint [1] 287478 0
6 months
Secondary outcome [1] 298255 0
Serum hormonal assay, of serum progesterone, prolactin, testosterone and TSH.
Timepoint [1] 298255 0
6 months

Eligibility
Key inclusion criteria
amenorrheic athletes
Minimum age
19 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
other endocrine disease

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)
closed envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4398 0
Egypt
State/province [1] 4398 0

Funding & Sponsors
Funding source category [1] 285595 0
Self funded/Unfunded
Name [1] 285595 0
Country [1] 285595 0
Egypt
Primary sponsor type
University
Name
Faculty of Physical education for Girls, alexandria university.
Address
Faculty of Physical education for Girls, alexandria university. Mostafa Kamel street, Fleming, alexandria, Egypt. 03312
Country
Egypt
Secondary sponsor category [1] 284426 0
None
Name [1] 284426 0
Address [1] 284426 0
Country [1] 284426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287597 0
the ethics committe of the faculty of physical education of females, Alexandria university
Ethics committee address [1] 287597 0
Mostafa Kamel Street, Fleming, Alexandria, Egypt. 03312
Ethics committee country [1] 287597 0
Egypt
Date submitted for ethics approval [1] 287597 0
Approval date [1] 287597 0
01/11/2010
Ethics approval number [1] 287597 0

Summary
Brief summary
The primary objective of this study was to find out if shiatsu can cause restoration of menses in amenorrheic athletes. Subjects were randomized in 2 equal groups, a study group and a control group. The study group had regular sessions of shiatsu 3 times weekly for 3 months and twice weekly for 3 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34410 0
Address 34410 0
Country 34410 0
Phone 34410 0
Fax 34410 0
Email 34410 0
Contact person for public queries
Name 17657 0
Mervat Sheikh Elarab Elsedeek
Address 17657 0
649 Elhoreya Road, Janaklis, Alexandria. 03312
Country 17657 0
Egypt
Phone 17657 0
+20 3 5747959
Fax 17657 0
+20 3 4832363
Email 17657 0
[email protected]
Contact person for scientific queries
Name 8585 0
Mervat Sheikh Elarab Elsedeek
Address 8585 0
649 Elhoreya Road, Janaklis, Alexandria. 03312
Country 8585 0
Egypt
Phone 8585 0
+20 35747959
Fax 8585 0
Email 8585 0
[email protected]

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.