Aim: To investigate the effect of pure and impure honey on severity of pain, amount of bleeding, and duration and interval of menstrual cycles in female students with primary dysmenorrhea.Method: The current study was a single-blind crossover design which will carry out on 60 female students with primary dysmenorrhea. After menstrual initiation, one group took pure honey until next menstrual period and after a 10 day wash-out period will start to take impure honey till the initiation of the subsequent menstrual cycle. Then dysmenorrhea will assess using Visual Analoque Scale. The similar procedure was performed by impure honey in the second group. The two groups are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205198348N3
Registration date:2012-06-23, 1391/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-23, 1391/04/03
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Science
Expected recruitment start date
2012-04-19, 1391/01/31
Expected recruitment end date
2012-06-17, 1391/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of honey on severity of primary dysmenorrhea
Public title
The effect of honey on severity of primary dysmenorrhea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 35-18 years, regular menstrual cycles of 28 days, and moderate to severe menstrual pain each menstrual cycle, lack of sensitivity to the honey, the absence of genital disease, failure to menstruate during the night.
Exclusion criteria: use of anti-inflammatory drugs oral contraceptives and nonsteroidal pain or bleeding at all during the whole period
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical science
Street address
Kashan, Ravand, kashan University of Medical Science
City
Kashan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
8778
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.6
ICD-10 code description
Dysmenorrhoea, unspecified
Primary outcomes
1
Description
Dysmenorrhea
Timepoint
Menstrual initiation and 1,2,3 hours after its
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Amount of bleeding, and duration and interval of menstrual cycles
Timepoint
One mounth
Method of measurement
Pad count,Demographic Questionnaire
Intervention groups
1
Description
Intervention group after the onset of menstruation, among five teaspoons of honey a day (40 g) were consumed in the morning until the next menstrual cycle.
Category
Placebo
2
Description
Control group after the onset of menstruation, among five teaspoons of impure honey a day (40 g) were consumed in the morning until the next menstrual cycle.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Residences Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Street address
Parastar Street, Ravand, Kashan University of Medical
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Street address
Parastar Street , Ravand, Kashan University of Medical
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Parastar Street, Ravand, Kashan University of Medical
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
salam_20012003@yahoo.co.uk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Parastar Street, Ravand, Kashan University of Medical
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
salam_20012003@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Parastar Street, Ravand, Kashan University of Medical
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
salam_20012003@yahoo.co.uk
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)