A comparative study on the effects of herbal capsule of Anise and Mefenamic acid on postpartum after pain on women that referred to Shohada Hospital of Ghochan
After pain is one of the complications occurring during postpartum, this requires an appropriate analgesic to relieve the pain. The current study was designed to study and compare the analgesic effects of Anise and Mefenamic acid capsule on postpartum pain. This study was a randomized double-blind controlled clinical trial in which pregnant mothers having normal vaginal delivery and suffering from postpartum pain were studied. Ninety six volunteer pregnant women were selected using Random-number table and entered into two study groups of Anise (intervention group) and Mefenamic acid (control group) oral capsules. Using the Numerical Analogue Scale, afterpain was determined during the first 1 hours after delivery and patient received drugs if a pain score 4 or more than 4 was expressed by patients. These women were administered 4 doses of during 24 hours (every 6 hours). Severity of pain were measured and recorded before and 1 hour after medication.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512203860N21
Registration date:2016-02-07, 1394/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-07, 1394/11/18
Registrant information
Name
Gity Ozgoli
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
gozgoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effects of herbal capsule of Anise and Mefenamic acid on postpartum after pain on women that referred to Shohada Hospital of Ghochan
Public title
A comparative study on the effects of herbal capsule of Anise and Mefenamic acid on postpartum after pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian; speak the Persian language; lives with his wife; they had normal vaginal delivery; single pregnancy with healthy baby; Gestational age between 37 to 42 weeks; the mother have the ability to breast-feeding; The baby can be feeding; mother for research is satisfied; women who suffer from postpartum pain; severity of postpartum pain is moderate to severe (scored more than 4 degree based on Numerical scale and need to use narcotics); normal vaginal delivery without devices (Vacuum, forceps); the mother does not have cesarean section and abdominal surgery history; Not used of epidural or spinal anesthesia; Non-smoking and drug abuse; the mother does not have a chronic disease (Hypertension, diabetes, heart disease, infectious diseases); No have allergy to Anise and other herbal drug; Exclusion criteria: herbal medicines or chemicals are used for pain relief during the study; the mother is suffering from serious complications after delivery (postpartum bleeding, temperature over 39 ° C, blood pressure higher than 140/90); continuation of breastfeeding to mother or baby is not possible causes; mother, for whatever reason are not willing to continue to participate in the study; foods containing spices are used during study
Age
From 20 years old to 30 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This research is a double-blind study in which researcher and patients are not aware about prescribed capsules. Capsules are put in the bar coded packets and given to the patients randomly.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-09-02, 1392/06/11
Ethics committee reference number
11635
Health conditions studied
1
Description of health condition studied
postpartum after pain
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination
Primary outcomes
1
Description
Severity of pain
Timepoint
Before intervention, one hour after delivery then every 6 hours for 24 hours
Method of measurement
Numerical Analogue Scale
Secondary outcomes
1
Description
The number of additional analgesic
Timepoint
one hour after delivery then every 6 hours for 24 hours
Method of measurement
Questionnaire
Intervention groups
1
Description
control group:The samples were given a Mefenamic Acid oral capsule 250mg ,one hour after delivery then every 6 hours for 24 hours.
Category
Treatment - Drugs
2
Description
Intervention group: The samples were given a Anise oral capsule containing 60 mg of dried extracts of anise ( produced in Shahid Beheshti pharmacy faculty ), one hour after delivery then every 6 hours for 24 hours.