This study aims at determining the effect of auriculotherapy in patients with PCOS. Study’s inclusion criteria are: 18-35-year-old unmarried girls with PCOS according to the Rotterdam criteria and at least one healthy ear who did not have a history of systemic, endocrine and nervous diseases, addiction or hyperprolactinemia and did not use any specific medication. Study’s exclusion criteria include: drug treatment during auriculotherapy, independent drug discontinuation, failure to refer for completing the treatment (if auriculotherapy group members did not refer for two sessions, they were excluded from the study. The seed is preserved for 4 days and its effect remains 72 hours after its removal) and the consumption of any hormone and psychiatric medications. This is a clinical trial study conducted on sixty 18-35-year-old unmarried girls with clinical, laboratory and ultrasonography symptoms. Samples were randomly divided into auriculotherapy and drug treatment groups who were under treatment for 2 and 3 months, respectively. Clinical symptoms in both groups were investigated in 3 steps. Research data was collcted via observation, laboratory investigation and ultrasonography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091614682N1
Registration date:2013-12-21, 1392/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-21, 1392/09/30
Registrant information
Name
Imaneh Khaki
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
0098
Email address
i_khaki@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University Of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2014-01-20, 1392/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An Investigation of the Effect of Auriculotherapy on Menstrual Irregularity Caused by PCOS in 18-35-Year-Old Unmarried Girls in Isfahan in 2012
Public title
Effect Of Ear Acupuncture On PolyCystic Ovarian Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Study’s inclusion criteria are: 18-35-year-old unmarried girls with PCOS according to the Rotterdam criteria and at least one healthy ear who did not have a history of systemic, endocrine and nervous diseases, addiction or hyperprolactinemia and did not use any specific medication.
Study’s exclusion criteria include: drug treatment during auriculotherapy, independent drug discontinuation, failure to refer for completing the treatment (if auriculotherapy group members did not refer for two sessions, they were excluded from the study. The seed is preserved for 4 days and its effect remains 72 hours after its removal) and the consumption of any hormone and psychiatric medications.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Isfahan university of Medical Sciences
Street address
Isfahan, Square Azadi
City
Isfahan
Postal code
Approval date
2012-11-07, 1391/08/17
Ethics committee reference number
391314
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
E28.2 Polycystic ovarian syndrome
Primary outcomes
1
Description
Irregular Mense
Timepoint
Before the intervention, one month after the intervention, two months after the intervention, immediately after intervention, after intervention in three dimensions
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group Auriculotherapy / every other day / 20 sessions /2 month / ten sessions after each menstrual cycle
Category
Treatment - Other
2
Description
medications / every day / three months / types of drugs used in the treatment of polycystic ovary syndrome
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Mother Mehr
Full name of responsible person
Mahbobeh Valiani
Street address
Mehre Mader Clinic,Third Floor, Azadi Center, between Banks Eghtesade Novin and Day, Azadi Square, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan university of Medical Sciences
Full name of responsible person
Maryam Kianpour
Street address
School of Nursing and Midwifery, Medical Sciences, Azadi Square, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
391314
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan university of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Master
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan university ofMedical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 1668 0042
Fax
Email
valiani@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Mahboubeh Valiani
Position
Masters
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan university ofMedical Sciences, Isfahan, Iran.