This study was a double blind clinical trial, conducted on 101 students of Shahid Beheshty University of Medical Sciences. The study participants randomly assigned in terms of imagery severity dysmenorrhea in two groups of 50 and 51 persons. The persons were assessed in study groups regarding: age, menarche age, the early dysmenorrheal age, body mass index, graduate and parent's job, length; space and quantity of period in similar groups. Fenugreek seed's capsule content of 900 mg seed powder prescribed 3 times a day and 2- 3 capsules duration first three days of menstrual period and for persons in control group prescribed placebo (similar capsule with same recipe content starch) in two cycles. Severity of pain compared base on spectrum analog scale 0 to 10 centimeter (Mcgill scale) and systematic signs used verbal multidimensional scoring system said before study and duration 2 continuous cycles.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106196807N2
Registration date:2012-01-26, 1390/11/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-26, 1390/11/06
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
Shahid Beheshty University of Medical Sciences
Expected recruitment start date
2011-08-06, 1390/05/15
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Fenugreek Seed on Primary Dysmenorrhoea in the selected student Dormitories of Shahid Beheshty University of Medical Sciences
Public title
Effect of Fenugreek Seed on Primary Dysmenorrhoea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being unmarried; having moderate or severe dysmenorrhea according to Mc Gill pain rating scale; not known chronic diseases; having regular intervals of 21 to 35 days menstrual periods; no history of Myoma, Pelvic tumor, Andometriosis & PID; no symptoms such as burning, itching & abnormal discharge during the study; no use of special drugs; no history of allergy to fenogreek or other plants and not taking herbal medicines during 3 months before intervention.
Exclusion criteria: allergy to fenugreek seed during intervention; incorrect taking the capsules; taking any other herbal medicine during intervention and taking less than 4 capsules daily.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
101
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
Shahid Beheshty University of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
Approval date
2011-07-24, 1390/05/02
Ethics committee reference number
1-7865-86-1-90
Health conditions studied
1
Description of health condition studied
Dysmenorea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Severity of pain
Timepoint
Two months before intervention and 2 months during intervention(3times during 3 days of menstration)
Method of measurement
Ruler of pain macgill; system of scali multiple verbal
2
Description
Severity of dysmenorrhea
Timepoint
Two months before intervention and 2 months during intervention
Method of measurement
Macgill pain scaling; multi verbalscaling
Secondary outcomes
1
Description
Dysmenorea
Timepoint
First three days of menstruation
Method of measurement
Mac gill scal
Intervention groups
1
Description
Control group: starch capsule, 500 mg , 3 times a day for 3 early periods day
Category
Placebo
2
Description
Intervention group: fenugreek seed capsule, 900mg 7 times a day for 3 early periods day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory Yas Flower, Shahid Beheshty University of Medical Sciences
Full name of responsible person
Sima Younesi. MS of midwifery
Street address
Valiasr Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshty University of Medical Sciences
Full name of responsible person
Dr Masomeh Simbar
Street address
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 Beheshty 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
Shahid Beheshty University of Medical Sciences
Full name of responsible person
Sedigheh Amir Ali Akbari
Position
Faculty member
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 2272 9240
Fax
Email
asa_akbari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshty University of Medical Sciences
Full name of responsible person
Sedigheh Amir Ali Akbari
Position
Faculty member
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 2272 9240
Fax
Email
asa_akbari@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)