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Comparison effects of vitamin E and Diclofenac gel on breast pain in patients

Protocol summary

Summary
The aim of the study: Comparison effects of vitamin E and Diclofenac gel on breast pain in patients Study design: Randomized clinical trial, without blinding, placebo-controlled, single-center, Phase 4 trials Study population: All patients with breast pain that come to clinic Inclusion criteria: having breast pain for more than six month; Patients with substantial pain, its intensity by the physician (visual analog scale) is measured; Other diseases is rejected; infertility is rejected(woman 18_49 age) Exclusion criteria: existence underlying breast disease in examination or sonography if necessary or mammography if necessary; having systemic diseases affecting on breast pains; contrainndication of vitamin E use; contraindication of NSAIDs use includ asthma, Hives, cardiovascular disease, sever renal diease; last tree month of pregnancy and lactation; People who have done open-heart surgery; users of supplementry drugs, NSAID, sedatives, sexual hormonal drugs; addicts and people not trend to be treatment. Target sample size: 60 Intervention: Tab vitamin E 400 mg, Orally Intervention time: Daily, for two months Primary outcome: the pain Secondary outcomes: Digestive disorder, diarhea, Asthma, Hives, cardiovascular disorder, third month of pregnancy, lactation

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061428464N1
Registration date: 2016-07-24, 1395/05/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-07-24, 1395/05/03
Registrant information
Name
Sahar Gholizadeh tahamta
Name of organization / entity
Islamic Republic Azad of Shahrood University
Country
Iran (Islamic Republic of)
Phone
+98 11 3272 6306
Email address
sahar.gholizadeh.t@iau_shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Sahebali manafi
Expected recruitment start date
2016-07-31, 1395/05/10
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of vitamin E and Diclofenac gel on breast pain in patients
Public title
Comparson effects of vitamin E and Diclofenac gel on breast pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having breast pain for more than six month; Patients with substantial pain, its intensity by the physician (visual analog scale) is measured; Other diseases is rejected; infertility is rejected(woman 18_49 age) Exclusion criteria: existence underlying breast disease in examination or sonography if necessary or mammography if necessary; having systemic diseases affecting on breast pains; contrainndication of vitamin E use; contraindication of NSAIDs use includ asthma, Hives, cardiovascular disease, sever renal diease; last tree month of pregnancy and lactation; People who have done open-heart surgery; users of supplementry drugs, NSAID, sedatives, sexual hormonal drugs; addicts and people not trend to be treatment.
Age
From 18 years old to 49 years old
Gender
Female
Phase
4
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
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Shahrood, Semnan
City
Shahrood
Postal code
Approval date
2015-05-13, 1394/02/23
Ethics committee reference number
1394.28 ir.FHMU.REC.ir

Health conditions studied

1

Description of health condition studied
Breast pain
ICD-10 code
N64.4
ICD-10 code description
Mastodynia

Primary outcomes

1

Description
pain
Timepoint
The first day of intervention, 30 days after the intervention, 60 days after the intervention
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Digestive disorder, diarhea, Asthma, Hives, cardiovascular disorder, third month of pregnancy, lactation
Timepoint
The first day of intervention, 30 days after the intervention, 60 days after the intervention
Method of measurement
Questionnair

Intervention groups

1

Description
The case group: Tab vitamin E 400 mg, Daily, for two months, Orally
Category
Treatment - Drugs

2

Description
Control Group: Diclofenac Gel 1%, amount of 0/25 gr, Twice a day, for two month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic
Full name of responsible person
Dr.Seyed Fatemeh Amirkhalili
Street address
Mehr apartmant, 22 Bahman street, Shahrood, Semnan
City
Shahrood

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Republic Azad of Shahrrood University
Full name of responsible person
Dr.Sahebali Manafi
Street address
Islamic Republic Azad of Shahrood University, Shahrood
City
Shahrood
Grant name
_
Grant code / Reference number
_
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Republic Azad of Shahrrood University
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
Islamic Republic Azad of Ahahrood University
Full name of responsible person
Dr.Seyed Fatemeh Amirkhalili
Position
General surgery doctor
Other areas of specialty/work
Street address
Islamic Republic Azad of Shahrood University, Shahrood
City
Shahrood
Postal code
Phone
+98 23 3223 1067
Fax
_
Email
Dr.amirkhalili@yahoo.com
Web page address
www.iau_shahrood.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Republic Azad of Shahrood University
Full name of responsible person
Dr.Seyed Fatemeh Amirkhalili
Position
General surgery doctor
Other areas of specialty/work
Street address
Islamic Republic Azad of Shahrood University, Shahrood
City
Shahrood
Postal code
_
Phone
+98 23 3223 1067
Fax
_
Email
Dr.amirkhalili@yahoo.con
Web page address
www.iau_shahrood.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Republic Azad of Shahrood University
Full name of responsible person
Sahar Gholizadeh
Position
Medical Interns
Other areas of specialty/work
Street address
Islamic Republic Azad of Shahrood University, Shahrood
City
Shahrood
Postal code
Phone
+98 23 3224 5042
Fax
_
Email
Sahar.gholizadeh68@gmail.com
Web page address
www.iau_shahrood.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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