After pain is a complication occurring during postpartum, which requires an appropriate analgesic to relieve the pain. The current study was designed to study and compare the analgesic effects of menstrogol and mefenamic acid on post-partum pain. This study was a randomized single-blinded controlled clinical trial in which pregnant mothers, having normal vaginal delivery and suffering from post partum pain, were studied. Volunteer pregnant women were randomly entered into two study groups of menstrogol (containing 500 mg of dried extracts of celery, saffron and anise) and mefenamic acid (250 mg) oral capsules. Using the visual analogue scale (VAS), After pain was determined during the first 2 hours after delivery and patients received the study drugs if a pain score ≥ 4 was expressed by patients. These women were administered 4-3 doses of study drugs per day (every 6-8 hours). Severity and duration of pain were measured and recorded before and 1 hour after dosage administration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201228801N1
Registration date:2012-04-21, 1391/02/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-21, 1391/02/02
Registrant information
Name
Masoumeh Simbar
Name of organization / entity
Shahid Beheshti University for Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2517
Email address
msimbar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-04-07, 1390/01/18
Expected recruitment end date
2012-02-07, 1390/11/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effects of Menstrogol ® and Mefenamic acid on postpartum pain
Public title
A comparative study on the effects of Menstrogol ® and Mefenamic acid on postpartum pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Participants were 17-35 years old women; primary or multiparous women who suffer from postpatum pain (scored more than 4 degree based on Visual scale and need to use narcotics); they had normal vaginal delivery; they had not any complication during childbirth, such as using vacuum or forceps, perineal laceration, prolonged labor, Neonate weight more than 3500g, birth of twins or more than one fetuses, using analgesics in previous 2 weeks; they had alive childbirth; infant without malformation; not using any drug in the ward (synthetics or herbal); they were in their 38-40 weeks for geststional age; they had no sensitivity to herbal medicines. Exclusion criteria: Participants who need to surgery or stronger analgesics, or experience the side effects.
Age
From 17 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Tavanir ave., After MirdaMad., Vali asr ave.
City
Tehran
Postal code
Approval date
2010-12-20, 1389/09/29
Ethics committee reference number
4336/116
Health conditions studied
1
Description of health condition studied
postpartum pain
ICD-10 code
O26
ICD-10 code description
Maternal care for other conditions predominantly related to pregnancy
Primary outcomes
1
Description
severity of pain
Timepoint
1 hour after usage of drug
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
duration of pain
Timepoint
1 hour after usage of drug
Method of measurement
upon hour and minute
2
Description
Side effects
Timepoint
1 hour after usage of drug
Method of measurement
Patients' side effects based on their statements
Intervention groups
1
Description
Group 2: One hour after childbirth, they were given a capsule of Mefenamic acid to relief their pain. The participants were given another dose of the drugs if their pain relapsed. This process was repeated to 4 times.
Category
Treatment - Drugs
2
Description
Group 1: One hour after childbirth, they were given a capsule of Menstrogl to relief their pain. The participants were given another dose of the drug if their pain relapsed. This process was repeated to 4 times.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zahra treatment and education center
Full name of responsible person
Street address
Ememzadeh ebrahim ave.
City
Ghom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Goldaru Company
Full name of responsible person
Dr. Fariborz Moattar
Street address
Esfehan Goldaru Company
City
Isfehan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Goldaru Company
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Rahmati
Street address
Deputy of resarch.,Shahid Beheshti University of Medical Sciences, Velenjak
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
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 Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Simbar
Position
Associate Professor/ PhD of reproductive health
Other areas of specialty/work
Street address
Department of Reproductive Health and Midwifery, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences (3th floor, Deputy of research), Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital
City
Tehran
Postal code
1996835119
Phone
+98 21 8820 2517
Fax
+98 21 8820 2517
Email
msimbar@sbmu.ac.ir
Web page address
sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Masoumeh Simbar
Position
phd of reproductive health
Other areas of specialty/work
Street address
Department of Reproductive Health and Midwifery, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences (3th floor, Deputy of research), Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital
City
Tehran
Postal code
1996835119
Phone
+98 21 8820 2516
Fax
+98 21 8820 2516
Email
msimbar@sbmu.ac.ir
Web page address
sbmu.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)