This study is a randomized controlled clinical trial and were performed in multiparous women were admitted in Obstetrics and Gynecology ward of zaeim hospital of pakdasht, due to normal vaginal
delivery in 2011. Sample size was 82 patients randomized in two groups fenugreek as case and
starch as placebo.2 groups were matched in terms of gravid , para,abortion,age and episiotomy. When patients complained of after pain, 2 capsules of drug or placebo were administered. The patients were visited for 24 hours. The pain, before the intervention and half an hour after intervention or atleast 4 hours after taking pain relief such as Mefenamic acid or brofen were measured by Mc Gill pain rating scale. Half an hour after each intervention, if the amount of pain was 2 or higher or on patient demand, a capsule of Mefenamic acid or brofen was
adminstereted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206106807N4
Registration date:2012-07-25, 1391/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-25, 1391/05/04
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 of Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
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
Effect of fenugreek seed capsule on after delivery pain
Public title
Effect of fenugreek on after delivery pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-people who have normal vaginal delivery; 2- people who have after delivery pain; 3-people who are multipar; 4-people who haven't NVD with vacumm , forceps or press on fondus; 5- Those people who aren't addict; 6-people who haven't L3 0r L4 rupture of perineum during NVD; 7-people who aren’t unread; 8-people who haven't history of allergy to fenogreek or other plants; 9-those haven’t history of c/s or other abdominal surgery.
Exclusion criteria:
1- Hospitalization time less than 18 hours after delivery and 2- if drugs couldn’t sedate the mother and other interventions was necessary.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
N/A
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 of medical sciences
Street address
tabnac street next to taleghany hospital
City
Tehran
Postal code
Approval date
2011-07-24, 1390/05/02
Ethics committee reference number
90-1-86-7865-1
Health conditions studied
1
Description of health condition studied
After pain
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination
Primary outcomes
1
Description
After pain
Timepoint
Before intervention & 3 or 4 times after interventiom
Method of measurement
McGill pain questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fenugreek seed.tab 900mg oral-per 6 hours for 24hours
Category
Treatment - Drugs
2
Description
Control group: placebo:2 starch capsule 500 mg oral per 6 hour until 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zaeim Hospital
Full name of responsible person
sedigheh amir ali akbari
Street address
nursing and midwifery faculty .Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahid beheshty of medical sciences
Full name of responsible person
Dr masomeh simbar
Street address
nursing and midwifery faculty 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 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 of medical sciences
Full name of responsible person
sedigheh amir ali akbari
Position
faculty member
Other areas of specialty/work
Street address
nursing and midwifery of shahid beheshty
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 of nedical sciences
Full name of responsible person
sedigheh amiir 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)