Introduction: Primary dysmenorrhea is described as pelvic pain around the time menstrual bleeding in the absence of an identifiable pathological lesion. It is a common gynecologic problem among women in reproductive age groups. Our objective was to compare the effect of Ginger and Fennel extract on primary dysmenorrhea. A randomized single blind, Placebo-controlled trial carry out among 75 single female students who inclusion criteria are including regular menstruation periods, range of age 18-30 years old, single girls with primary dysmenorrhea and exclusion criteria are including being affected by known diseases, Symptoms such as burning, itching, abnormal vaginal discharge; history of PID, tumor and fibrom; history of drug or herbal allergy and appearance of stressful events (divorce and death of parents and relatives) have joined to the study group in recent 6 month and during the treatment period. Students divided into 3 groups randomly: Fennel extract, Ginger extract and placebo. Groups use treatment four times a day from the onset of bleeding and continue through three days for two consecutive menstrual periods. Moreover, two questionnaires has given to them until comleting the intensity of pain (according VAS and verbal multidimensional scoring system) and duration of pain(number of days pain) and in the related forms after treatment during each menstruation period and to deliver to researcher after the end of period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212226705N2
Registration date:2015-05-06, 1394/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-06, 1394/02/16
Registrant information
Name
Leila Moslemi
Name of organization / entity
Islamic Azad University Sari Branch
Country
Iran (Islamic Republic of)
Phone
+98 15 1213 3875
Email address
moslemi.leila@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Sari Branch, Islamic Azad University
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of Ginger and Fennel extract on severity primary Dysmenorrhea
Public title
Effect of herbal drugs on menstrual pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are including regular menstruation periods, range of age 18-30 years old, single girls with primary dysmenorrhea and exclusion criteria are including being affected by known diseases, Symptoms such as burning, itching, abnormal vaginal discharge; history of pelvic infection disease, tumor and fibrom; history of drug or herbal allergy and appearance of stressful events (divorce and death of parents and relatives) have joined to the study group in recent 6 month and during the treatment period.
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:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Sari Branch
Street address
Firuzkande, Complex University of Islamic Azad Sari, Office building, The fifth flooR, Vice chancellor for research
City
Sari
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
1391-5
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Intensity of Primary Dysmenorrhea
Timepoint
A month before intervention and 2 months during intervention
Method of measurement
Visual analog scale and verbal multidimensional scoring system
Secondary outcomes
1
Description
Duration of Primary Dysmenorrhea
Timepoint
A month before intervention and 2 months during intervention
Method of measurement
Number of days
Intervention groups
1
Description
Fennel extract capsule 46 mg used treatment four times a day from the onset of bleeding and continued through three days for two consecutive menstrual periods.
Category
Treatment - Drugs
2
Description
Ginger extract capsule ,250 mg, four times a day from the onset of bleeding and continued through three days for two consecutive menstrual periods
Category
Treatment - Drugs
3
Description
Placebo capsule four times a day from the onset of bleeding and continued through three days for two consecutive menstrual periods
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical School at Islamic Azad University Sari Branch
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University Sari Branch
Full name of responsible person
Leila Moslemi
Street address
Firuzkande, Complex University of Islamic Azad Sari, Office building, The fifth floor, Vice chancellor for Research
City
Sari
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 and Technology, Islamic Azad University Sari Branch
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
Midwifery group, Medical School, Islamic Azad University Sari Branch
Full name of responsible person
Leila Moslemi
Position
MSC Midwifery
Other areas of specialty/work
Street address
Firuzkande, Complex University, Islamic Azad University Sari Branch
City
Sari
Postal code
Phone
+98 11 3213 3857
Fax
Email
moslemi.leila@iausari.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Midwifery group, Medical School, Islamic Azad University Sari Branch
Full name of responsible person
Leila Moslemi
Position
MSC Midwifery
Other areas of specialty/work
Street address
Firuzkande, Complex University, Faculty of medical science, Islamic Azad University Sari Branch
City
Sari
Postal code
Phone
+98 11 3213 3857
Fax
Email
moslemi.leila@iausari.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Midwifery group, Medical School, Islamic Azad University Sari Branch
Full name of responsible person
Leila Moslemi
Position
MSC Midwifery
Other areas of specialty/work
Street address
Firuzkande, Complex University, Faculty of medical science, Islamic Azad University Sari Branch
City
Sari
Postal code
Phone
00
Fax
Email
moslemi.leila@iausari.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)