Present study will be conducted to compare the effect of auriculotherapy and vitamin B6 on the symptoms of premenstrual syndrome.
This study is a clinical trial. female students who live at university dorm will be randomly selected and allocated into two groups of 46.Inclusion criteria: 18 to 35 year old; having regular menstruation cycles with equal intervals (21- 35 days); not having a history of psychological or chronic physical diseases; Not having a history of using anti-depressant; hormonal drugs and also drugs that have interactions with vitamin B6 and not having any kind of mass, infection or scar on the external ear. Exclusion criteria: Occurrence of any undesirable incidence or death; not presenting all the auriculotherapy sessions correctly and completely; not pressuring the seeds in the auriculotherapy group and not completing the table of symptoms’ severity recordings .The first group will receive auriculotherapy (10 sessions) for 2 menstrual cycles and the second group will consume 40 mg of vitamin B6 daily from a week prior to their menstruation for 2 menstrual cycles. The severity of symptoms will be recorded for both groups during two cycles before the intervention and two cycles after the intervention. Data gathering tool is a questionnaire with 28 questions.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201509182889N5
Registration date:2017-01-09, 1395/10/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-09, 1395/10/20
Registrant information
Name
Mahboubeh Valiani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 4640
Email address
valiani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of auriculotherapy and vitamin B6 on the symptoms of premenstrul syndrome
Public title
Comparing the effect of auriculotherapy and vitamin B6 on the symptoms of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 35 year old; having regular menstruation cycles with equal intervals (22 to 35 days); having 5 signs of pms in last 2 months; normal BMI ; not having a history of psychological or chronic physical diseases and depression; Not having a history of using anti-depressant; sedatives and hormonal drugs and also drugs that have interactions with vitamin B6 and not having any kind of mass, infection or scar on the external ear .
Exclusion criteria: Occurrence of any undesirable incidence or death; not presenting all the auriculotherapy sessions correctly and completely (more than 2 consecutive absences);not pressuring the seeds in the auriculotherapy group and not completing the table of symptoms’ severity recordings would cause the participants to be excluded.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sealed envelope method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences and Health Services
Street address
Isfahan university of Medical sciences
City
Isfahan
Postal code
319081775
Approval date
2015-07-22, 1394/04/31
Ethics committee reference number
ir.mui.rec.1394.394342
Health conditions studied
1
Description of health condition studied
premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
premenstrual tention syndrome
Primary outcomes
1
Description
premenstrual syndrome(edema, low back pain,low abdominal pain,mastalgia,..)
Timepoint
Before of intervention, 1,2,month after intervention
Method of measurement
DSM-IV questionnair
Secondary outcomes
1
Description
General health-Depression-Anxiety
Timepoint
preintervention -1 and 2month after intervention
Method of measurement
GHQ(28) and Beck questionairs
Intervention groups
1
Description
Intervention group 1: the auriculotherapy will be executed in 10 weekly sessions during 2 menstruation cycles (except for the 7 days of menstrual bleeding). Each session will be lasted about 20 minutes and will be conducted by the researcher at the dorm in a private place that will be considered for this matter. At each session Shenmen, zero, endocrine, ovary, womb, adrenal, kidney, external genitalia, liver, brain and brainstem points will be stimulated. At the end of each session herbal seeds will be placed on specified points and will be remained for at least 3 days; seeds will be pressured by the participant for a whole minute every hour except for the time of sleep. Phone calls will be made for reminding.
Category
Treatment - Other
2
Description
Intervantion group 2: They will take Vitamin B6 (40 mg) (made by Iran Hormone Company), daily from one week before starting of menstrual bleeding. This group will continue the consumption of B6 during the two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dorms of Isfahan university of Medical sciences
Full name of responsible person
reza ghasemi
Street address
Isfahan universityof Medical sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Research Department of Medical Sciences
Full name of responsible person
Mehdi Nemathbakhsh
Street address
Isfahan University of Medical Sciences, Hezar jereb street, Esfaha
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Research Department 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
sharareh koleini
Position
MS
Other areas of specialty/work
Street address
Isfahan University of Medical Science, Hezar jereb street, Shiraz Gate
City
Isfahan
Postal code
8199939438
Phone
+98 31 3792 2936
Fax
Email
sharareh_Koleini@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Mahboube Valiani
Position
Isfahan university of medical sciences
Other areas of specialty/work
Street address
Ms
City
Isfahan of university of medical sciences
Postal code
8199939438
Phone
+98 31 3792 2936
Fax
Email
valiani@nm.mui.ac.ir
Web page address
mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Sharareh_Koleini
Position
Ms
Other areas of specialty/work
Street address
Isfahan University of Medical Science, Hezar Jereb Street, Shiraz Gate, Isfahan
City
Isfahan university of medical sciences
Postal code
8173785737
Phone
+98 31 3626 3804
Fax
Email
sharareh_koleini@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)