Effect of capsule including Fenugreek seed versus placebo on severity and duration of pain in girls with primary dysmenorrhea: a single-blind randomized clinical trial
Objectives: To assess the effect of capsule including Fenugreek seed versus placebo on severity and duration of pain in girls with primary dysmenorrhea.
Design: a single-blind randomized clinical trial.
Setting and conduct: The eligible girl college students with primary dysmenorrhea who study at the Hamadan University of Medical Sciences during the study period will be enrolled into the trial.
Inclusion criteria: single; age of 19 to 35 years; moderate to severe primary dysmenorrhea; regular periods of 21 to 35 days.
Exclusion criteria: having chronic diseases; using any medications; sensitivity to Fenugreek; using any herbal drugs during the last 3 months; incomplete use of Fenugreek seed.
Intervention group: two capsules including 900 mg Fenugreek seed every 8 hours from the first day of period or beginning of pain for 3 days in 2 consecutive months.
Control group: two capsules of placebo every 8 hours from the first day of period or beginning of pain for 3 days in 2 consecutive months
Primary outcome: (a) assessing the severity of pain every 8 hours during the period using McGill ruler pain; (b) assessing the duration of pain during the period on basis of day by taking history.
Secondary outcome: Nothing.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: The participants will be unaware of the type of intervention. Therefore, the trial will be run as a single-blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608019014N107
Registration date:2016-08-04, 1395/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2006-04-21, 1385/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of capsule including Fenugreek seed versus placebo on severity and duration of pain in girls with primary dysmenorrhea: a single-blind randomized clinical trial
Public title
Effect of capsule including Fenugreek seed versus placebo on severity and duration of pain in girls with primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: single; age of 19 to 35 years; moderate to severe primary dysmenorrhea; regular periods of 21 to 35 days.
Exclusion criteria: having chronic diseases; using any medications; sensitivity to Fenugreek; using any herbal drugs during the last 3 months; incomplete use of Fenugreek seed.
Age
From 19 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: The participants will be unaware of the type of intervention. Therefore, the trial will be run as a single-blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.UMSHA.REC.1395.7
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
assessing the severity of pain
Timepoint
every 8 hours during the period
Method of measurement
using McGill ruler pain
2
Description
assessing the duration of pain
Timepoint
during the period
Method of measurement
on basis of day by taking history
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
two capsules of placebo every 8 hours from the first day of period or beginning of pain for 3 days in 2 consecutive months
Category
Treatment - Drugs
2
Description
two capsules including 900 mg Fenugreek seed every 8 hours from the first day of period or beginning of pain for 3 days in 2 consecutive months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nursing and Midwifery
Full name of responsible person
Reihaneh Ebrahimi
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Full name of responsible person
Reihaneh Ebrahimi
Position
Midwifery Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
r.ebrahimi41@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Dr Farzaneh Soltani
Position
Fertility Health Specialist
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+81 38381086
Fax
Email
Farzanehsoltani2008@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)