Objective: Study on effects of topical Nigella sativa seed oil in treatment of cyclic mastalgia. Study population: Women with cyclic mastalgia attending the Yazd Shahid Rahnemoon hospital (Iran). Sample size: 150 patients. Inclusion criteria: Iranian outpatient females with cyclic mastalgia, patients aged 25-45 years; patients with regular menstrual cycles; patients with cyclic mastalgia diagnosis based on history of cyclic mastalgia for at least the past 3 consecutive cycles, patients with pain duration of at least 7 days per month and mastalgia severity score greater than 4 on a 10 centimeter visual analogue scale requiring pharmacotherapy. Exclusion criteria: Patients receiving hormone therapy or hormonal contraceptive; patients with irregular menstrual cycles; patients with history of breast and endometrial cancer, hysterectomy and bilateral oophorectomy; pregnanct women; brest-feeding women; women planning pregnancy; women with serious health problems. Intervention: Each of the Nigella sativa seed oil, diclofenac and placebo gels is separately applied 2 times daily to the site of breast pain in a group of 50 women with cyclic mastalgia. At the end of the study, the drugs effects on the 10 centimeter visual analog pain score are determined and compared with each other.
General information
Acronym
SETNSOTCM
IRCT registration information
IRCT registration number:IRCT201506132288N8
Registration date:2015-06-25, 1394/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-25, 1394/04/04
Registrant information
Name
Saeed Kianbakht
Name of organization / entity
Iranian Academic Center for Education, Culture and Research Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26147640109
Email address
kianbakht@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
ACECR Institute of Medicinal Plants
Expected recruitment start date
2014-04-26, 1393/02/06
Expected recruitment end date
2014-10-31, 1393/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on effects of topical Nigella sativa seed oil in treatment of cyclic mastalgia.
Public title
Study on effects of black seed oil in treatment of cyclic mastalgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian outpatient females with cyclic mastalgia, patients aged 25-45 years; patients with regular menstrual cycles; patients with cyclic mastalgia diagnosis based on history of cyclic mastalgia for at least the past 3 consecutive cycles, patients with pain duration of at least 7 days per month and mastalgia severity score greater than 4 on a 10 centimeter visual analogue scale requiring pharmacotherapy. Exclusion criteria: Patients receiving hormone therapy or hormonal contraceptive; patients with irregular menstrual cycles; patients with history of breast and endometrial cancer, hysterectomy and bilateral oophorectomy; pregnanct women; brest-feeding women; women planning pregnancy; women with serious health problems.
Age
From 25 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Sciences
Street address
Boulevar of Shohadayeh Gomnan
City
Yazd
Postal code
2317356371
Approval date
2014-04-09, 1393/01/20
Ethics committee reference number
1217
Health conditions studied
1
Description of health condition studied
Mastalgia
ICD-10 code
N64.4
ICD-10 code description
Mastodynia
Primary outcomes
1
Description
Pain severity score
Timepoint
Before, 1 and 2 months after beginning of the intervention
Method of measurement
10 centimeter visual analog scale
Secondary outcomes
1
Description
Adverse drug reactions
Timepoint
1 and 2 months after beginning of the intervention
Method of measurement
Patient report
Intervention groups
1
Description
Nigella sativa seed oil gel is used at the dose of 600 mg topically on the site of breast pain twice daily in 50 patients for 2 months
Category
Treatment - Drugs
2
Description
Diclofenac gel is used at the dose of 20 mg topically on the site of breast pain twice daily in 50 patients for 2 months
Category
Treatment - Drugs
3
Description
Placebo gel is used topically on the site of breast pain twice daily in 50 patients for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahnemoon hospital
Full name of responsible person
Dr. Mohammad Hosein Mirshamsi
Street address
Farrokhi street
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Street address
Pouleh kordan, Supa boulevard, ACECR complex
City
Karaj
Grant name
1252
Grant code / Reference number
1252
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ACECR Institute of Medicinal Plants
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
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
skianbakht@yahoo.comskianbakht@gmail.com
Web page address
www.imp.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
skianbakht@yahoo.comskianbakht@gmail.com
Web page address
www.imp.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
skianbakht@yahoo.comskianbakht@gmail.com
Web page address
www.imp.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)