Evaluation of effectiveness of Cinnamon and placebo on primary dysmenorrhea in girls in dormitories of Isfahan University of Medical Sciences and Isfahan University
Objective: To determine the effectiveness of the cinnamon on primary dysmenorrhea in Girls in dormitories of Isfahan University of Medical Sciences and the Isfahan university
Design: Randomized, double-blind (blind to participants and experimenters), placebo-controlled, multicenter.
Methods:
Inclusion criteria: being single
; Age between 18 to 30 years ; Having a regular menstrual cycle ; Having primary dysmenorrhea ; No history of genital surgery ; No history of any allergies, especially to plants ; Not having internal diseases (diabetes, hypertension, kidney disease, etc.)
Exclusion criteria:
Irregular cycle less than 21 days and no more than 45 days during use ; Having allergy during use ; The use of any medications, including hormonal medications and painkillers during doing the study ; Not using the treatment correctly
The total sample size: 80 cases. 40 cases in the intervention group and 40 cases in the control group.
Intervention: empty capsules are filled with 500 mg cinnamon powder and Two capsules are given every 8 hours to the intervention group. empty capsules are filled with starch powder and Two capsules are given every 8 hours to the control group.
Intervention time: with starting menstrual cycle, Two capsules are taken every 8 hours and this process will continue for three days.
Outcome: pain relief in primary dysmenorrhea
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101024452N1
Registration date:2015-11-01, 1394/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-01, 1394/08/10
Registrant information
Name
Maryam Jahangirifar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3331 2806
Email address
m_jahangiri@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-09-22, 1394/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of Cinnamon and placebo on primary dysmenorrhea in girls in dormitories of Isfahan University of Medical Sciences and Isfahan University
Public title
Evaluation of effectiveness of Cinnamon on menstrual pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being singleAge between 18 to 30 years ; Having a regular menstrual cycle
Having primary dysmenorrhea ; No history of genital surgery ; No history of any allergies, especially to plants ; Not having internal diseases (diabetes, hypertension, kidney disease, etc.)
Exclusion criteria: Irregular cycle less than 21 days and no more than 45 days during use ; Having allergy during use ; The use of any medications, including hormonal medications and painkillers during doing the study ; Not using the treatment correctly
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics comitte of Isfahan university of Medical Sciences
Street address
Hezar jarib street, Isfahan university of medical science, Isfahan.
City
Isfahan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2015-01-05, 1393/10/15
Ethics committee reference number
293350
Health conditions studied
1
Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
The mean intensity of primary dysmenorrhea
Timepoint
Before the intervention, one month after the intervention, two months after the intervention
Method of measurement
The pain visual analog scale (McGill pain ruler)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: Every 8 hours two capsules containing 500 mg of cinnamon powder are consumed for the first three days of menstrual cycles and two menstrual cycles.
Category
Treatment - Drugs
2
Description
The control group: Every 8 hours two capsules containing Starch powder are consumed for the first three days of menstrual cycles and two menstrual cycles.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitories of Isfahan University of Medical Sciences
Full name of responsible person
Maryam Jahangirifar
Street address
Dormitories of Isfahan University and Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
2
Recruitment center
Name of recruitment center
Dormitories of Isfahan University
Full name of responsible person
Street address
Dormitories of Isfahan University and Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Nursing and Midwifery Faculty, Isfahan University of Medical Science
Full name of responsible person
Ashraf Kazemi
Street address
Vice Chancellor for Research of Nursing and Midwifery Faculty, Isfahan University of Medical Science
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Nursing and Midwifery Faculty, Isfahan University of Medical Science
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
Isfahan university of medical sciences
Full name of responsible person
Maryam Jahangirifar
Position
master student of midwifery
Other areas of specialty/work
Street address
Isfahan university of medical sciences, Hezar jarib street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3331 2806
Fax
Email
m.jahangirifar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Jahangirifar
Position
Master Student of Midwifery
Other areas of specialty/work
Street address
Isfahan University of Medical Science, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3331 2806
Fax
Email
m.jahangirifar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Jahangirifar
Position
Master student of midwifery
Other areas of specialty/work
Street address
Isfahan University of Medical Science, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3331 2806
Fax
Email
m.jahangirifar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)