Evaluation of the effect of vitamin B6 on reducing the number and size of the breast cysts and rate of recurrence after aspiration in Amiralmomen Hospital,Semnan
In this double blind randomized clinical trial study, reduction of the size and number of the breast cysts after consumption of Vitamin B6 is evaluated. In patient with palpable cyst, at first the cyst is aspirated. These patients and patients with non-palpable cysts will be divided in two groups; in case group 150 mg Vitamin B6 BD and in control group placebo will be used for two months. In all patients cysts size and number will be recorded before and after the trial according to sonographic findings. At the end findings in two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102615162N1
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
Jafar Alavy Toussy
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1445 7244
Email address
drtoussy@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin B6 on reducing the number and size of the breast cysts and rate of recurrence after aspiration in Amiralmomen Hospital,Semnan
Public title
Evaluation of the effect of vitamin B6 on reducing the number and size of the breast cysts and rate of recurrence after aspiration
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Palpable and non-palpable breast cysts (detected in sonography); Palpable breast cysts which evacuated completely after aspiration; 3- Patients in reproductive ages
Exclusion criteria: Complex breast cysts according to sonographic findings; Bloody fluid in aspiration of the breast cyst; Cysts that not completely resolved after aspiration; Cysts with mammographic suspicious findings; patients that consume OCP
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Basij Boulevard
City
Semnan
Postal code
Approval date
2013-06-11, 1392/03/21
Ethics committee reference number
92/16/3682
Health conditions studied
1
Description of health condition studied
Solitary cyst of breast
ICD-10 code
N60.0
ICD-10 code description
Solitary cyst of breast
2
Description of health condition studied
Diffuse cystic mastopathy
ICD-10 code
N60.1
ICD-10 code description
Diffuse cystic mastopathy
Primary outcomes
1
Description
Size of breast cysts
Timepoint
Begining of study, End of study
Method of measurement
Breast sonography
2
Description
Number of breast cysts
Timepoint
Beginning of study, End of Study
Method of measurement
Breast sonography
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, Vitamin B6 150 mg BD for 2 months (powdered tablet in capsule, produced by Iran Hormone company).
Category
Treatment - Drugs
2
Description
In control group placebo (containing sugar in the same capsules) prescribed as the case group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery clinic of Amir-al-Momenin Hospital
Full name of responsible person
Dr Setareh Soltany
Street address
Surgery department, Koosar Hospital, Shahrak-e Golestan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rahbar
Street address
Basij Boulevard, Moavenet-e Tahghigat
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?