This double blind clinical trial will be performed on 110 female students of Hamedan University of Medical Sciences. Subjects with inclusion criteria: 18-24 years of age; regular menstrual periods with 21-35 day cycles and 3-10 days bleeding period; no identified physical and Pelvic diseases and exclusion criteria: taking 20 drop of Rosaceous or less on two consecutive days; allergy to Rosaceous during intervention, will be divided into two groups of 55 subjects randomly and will use 10 drops of Rosaceous sinensis or placebo two times a day during first three days of menstrual period for two consecutive months. Pain intensity will be measured by a visual analogue scale three times a day and a four-point verbal rating scale will be employed to evaluate systemic symptoms. The present study examines the effect of Rosaceous on the severity and systemic symptoms of primary dysmenorrhea.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311216807N10
Registration date:2014-11-05, 1393/08/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-05, 1393/08/14
Registrant information
Name
Sedigheh Amir Ali Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9240
Email address
akbarisedd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-06-16, 1393/03/26
Expected recruitment end date
2014-10-18, 1393/07/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Rosaceous Sinensis on the severity of dysmenorrhea in subjects with primary dysmenorrhea
Public title
Effect of Rosaceous Sinensis on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-24 years of age; regular menstrual periods with 21-35 days cycles and 3-10 days bleeding period; no identified physical and Pelvic diseases. Exclusion criteria: taking 20 drop of Rosaceous or less on two consecutive days; allergy to Rosaceous during intervention.
Age
From 18 years old to 24 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
110
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 committee of Shahid Beheshti University of Medical Sciences and health services
Street address
Shahid Beheshti University of Medical Sciences, Velenjak Street, Shahid Chamran High Way, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2014-06-16, 1393/03/26
Ethics committee reference number
1393-1-86-12862-1
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary Dysmenorrhea
Primary outcomes
1
Description
Intensity of pain
Timepoint
Eight weeks before treatment, Eight weeks after treatment
Method of measurement
Macgill pain scaling
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Control group: Water and sugar, Ten drops, Two times a day for first Three days of period
Category
Placebo
2
Description
Intervention group: Rosaceous Sinensis, Ten drops, Two times a day for first Three days of period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory of Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ali Ataei
Street address
Hamedan University of Medical Sciences, next to Luna park, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Simbar
Street address
School of Nursing and Midwifery, Opp. Shahid Rajaee Heart Hospital, Niyayesh Crossing, Valie Asr Ave, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seddighe Amir Ali Akbari
Position
Msc.
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Opp. Shahid Rajaee Heart Hospital, Niyayesh Crossing, Valie Asr Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
asa_akbari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seddighe Amir Ali Akbari
Position
Msc.
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Opp. Shahid Rajaee Heart Hospital, Niyayesh Crossing, Valie Asr Ave, Tehran
City
Tehran
Postal code
1996835119
Phone
+98 21 8820 2512
Fax
Email
asa_akbari@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)