The aim of this double blind randomized controlled trial is to determine the effect of Mephenamic acid dnd Vitex on copperIUD-induced bleeding and 84 cases of 15-40 years old with copperIUD who have insertion at least 3 monthes ago and with IUD-induced bleeding cpmpliant .Inclusion criterias are: without any drug alergy, atleast 3 monthes past from IUD insertion, IUD - Induced bleeding, without disorders of consumption mefenamic acid ( gastrointestinal ulsers ,sensitiveness ,...),atleast education (writing &reading ), without any genital infection.
Exclusion criteria : any drug disorders after treatment.After getting written informed consent, we will randomly allocate them into intervention and control groups with block sizes of four and six concealed in sequentially numbered identiical containers that are administered serially to participant. Vitex will be used in Mephenamic acid covers .All cases in two groups will be consumpted 3 capeules on day (first day of period untill the end of period )in month for 4 monthes. Amount of bleeding before and after treatmentes will be evaluated for every month and effection of drugs will be compared for 4 monthes . Pads have the samepower on obsorption and made of same factory.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108267418N1
Registration date:2012-03-15, 1390/12/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-15, 1390/12/25
Registrant information
Name
Parisa Yavarikia
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
yavarikiap@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Effect Of Mefenamic Acid And Vitex Agnus Castus On IUD- Iinduced Bleeding
Public title
Effect of Mefenamic Acid And Vitex Agnus Castus On IUD- Induced Bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Without any drug alergy; Atleast 3 monthes past from IUD insertion; IUD - Induced bleeding ; without disorders of consumption mefenamic acidExclusion criteria : Any drug disorders after intervention
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences - Deputy Of Research
Street address
Tabriz- Golgasht st-Tabriz University Of Medical Sciences-No 2 Building -3 floor -Deputy Of Research
City
Tabriz
Postal code
51665118
Approval date
2011-09-26, 1390/07/04
Ethics committee reference number
5/4/5461
Health conditions studied
1
Description of health condition studied
Uterine Bleeding
ICD-10 code
n93.9
ICD-10 code description
Abnormal Uterine and Vaginal bleeding Unspecified
Primary outcomes
1
Description
months' bleeding
Timepoint
Before and 1and 2 and 3 and 4 monthes after intervention
Method of measurement
Higam table with atleast 100 score
Secondary outcomes
empty
Intervention groups
1
Description
In this study will be used vitex 3 times aday from the first day of period to last bleeding for 4 monthes . it has 1.2-3.3 mg Equin in every meal .Vitex will be used in Mephenamic Acid cover and same as it. Mephnamic Acid will be used 50 mg ,3 times a day for 4 monthes .
Category
Treatment - Drugs
2
Description
In other group will be used Mephenamic acid 500 mg 3 times a day from first day of period until the last period for 4 monthes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Karag health and treatment centers
Full name of responsible person
Samira Hadavand
Street address
Tabriz south shariati street nursing and midwifery faculty
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Tabriz Daneshgah Street Bleeding 2 floor 5 Deputy of researches
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University Of Medical Scinces - Nursing And Midwifery Faculty
Full name of responsible person
Samira Hadavand Mirzaie
Position
Master of Midwifery Student
Other areas of specialty/work
Street address
Tabriz South Shariati Nursing And Midwifery Faculty Midwifery Department
City
Tabriz
Postal code
Iran
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
p_k_hn@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Scinces - Nursing And Midwifery Faculty
Full name of responsible person
Parisa Yavarikia
Position
Academic Member
Other areas of specialty/work
Street address
Tabriz SouthShariati Nursing And Midwifery Faculty Midwifery Department