The aim of our study is to assess anti-inflammatory effects of curcumin in preparations for topical use comparing to placebo in patients with lactational mastitis. Individuals in one group will be treated with a topical curcumin cream as an anti-inflammatory agent (curcumin-treated group). The topical Curcumin Cream-200mg per pump (Neurobiologix, Texas, USA) will be prescribed with the following method: patients will be asked to apply one pump of the cream to the affected breast each 8 hours for a course of treatment which lasted 72 hours. On the other group, individuals will be prescribed with a topical moisturizer cream as the placebo (placebo group) and the treatment course are similar to the curcumin-treated group. Moreover, prior to randomization, all of the patients will been taught for effective milk removal for 24 hours as the standard first line of treatment. In order to obtain the values for breast tension, pain and erythema all of the participants will be evaluated clinically by one expert staff nurse before starting treatment. After treatment are initiated, patients will be reevaluated by the same staff nurse 3 times with intervals of 24 hours in order to record changes of inflammation severity index. The patients will be randomized using a computer-based random digit generator based on the registration number of the patients (on the order of refer). Study creams will be allocated in separate packs blinded and labeled using a four-digit code. The information regarding which codes correspond to what treatment will be maintained by the consulting statistician.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051811375N4
Registration date:2014-05-26, 1393/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-26, 1393/03/05
Registrant information
Name
pouya farhadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1625 4206
Email address
farhadip@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-10-01, 1390/07/09
Expected recruitment end date
2012-04-30, 1391/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Topical Curcumin for Treatment of Mastitis in Breastfeeding Women: a randomized, double-blind, placebo-controlled clinical trial.
Public title
Effectiveness of Topical Curcumin for Treatment of Mastitis in Breastfeeding Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Breast feeding women with aged 20-40 years old; Breast feeding women with inflammatory symptoms of breast during lactation; Patients with inflammation scored 8-14 based of inflammation severity index. Exclusion Criteria: women with breast abscess, breast engorgement, blocked duct and galactocelle; Individuals who has a previous history of mastitis, recent trauma to the affected breast, breast surgery, inflammatory skin diseases and recurrent mastitis; Mothers who has taken systemic antibiotics in the recent 2 months.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Shiraz University of Medical Sciences
Street address
Shiraz university of medical sciences Building, 7th floor, Zand Ave.
City
Shiraz
Postal code
Approval date
2011-05-07, 1390/02/17
Ethics committee reference number
CT-P-90-5163
Health conditions studied
1
Description of health condition studied
Mastitis
ICD-10 code
N61
ICD-10 code description
Inflammatory disorders of breast
Primary outcomes
1
Description
Inflammation severity
Timepoint
Before and 24h, 48h, 72h after intervention
Method of measurement
Inflammation severity index
Secondary outcomes
1
Description
Pain Severity
Timepoint
Before and 24h, 48, 72h after intervention
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Individuals in intervention group will be treated with a topical curcumin cream (200mg per pump) as an anti-inflammatory agent. Patients will be asked to apply one pump of the cream to the affected breast each 8 hours for a course of treatment which lasted 72 hours.
Category
Treatment - Drugs
2
Description
In placebo group, individuals will be prescribed with a topical moisturizer cream as the placebo (placebo group) and the treatment course is similar to the intervention group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Breastfeeding clinic of Shiraz university of Medical Sciences
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Midical Sciences
Full name of responsible person
Basir Hashemi
Street address
Shiraz university of medical sciences, Zand Ave
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Midical 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Pouya Farhadi
Position
General Physician
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Postal code
Phone
+98 71 1234 3529
Fax
Email
farhadip@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Raha Afshariani
Position
M.D, IBCLC, ALC
Other areas of specialty/work
Street address
Department of Public health, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1224 0249
Fax
Email
rahaafshariani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Pouya Farhadi
Position
General Physician
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Postal code
Phone
+98 71 1234 3529
Fax
Email
farhadip@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)