A comparative study on the effect of herbal capsules Melisa and Mefnamic acid on postpartum after pain on women that referred to Askarie hospitals of Isfahan in 2016
This study was a randomized double-blind controlled clinical trial in which pregnant mothers having normal vaginal delivery and suffering from postpartum. In this study were compared the analgesic effects of Melisa and Mefenamic acid capsule on postpartum pain. 70 volunteer pregnant women were selected using Random-number table and entered into two study groups of Melisa (intervention group) and Mefenamic acid (control group) oral capsules. Using the Numerical Analogue Scale, after pain was determined during the first 2 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:IRCT201608023860N25
Registration date:2016-12-28, 1395/10/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-28, 1395/10/08
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 International Branch of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of herbal capsules Melisa and Mefnamic acid on postpartum after pain on women that referred to Askarie hospitals of Isfahan in 2016
Public title
A comparative study on the effects of herbal capsule of Melisa 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 Melisa and other herbal drug.
Exclusion criteria: 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.
Age
From 19 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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 The International Branch of Shahid Beheshti University Of Medical Sciences & Hea
Street address
Shahid Abaspur st, Tavanir st, Hemmat bridge
City
Tehran
Postal code
Approval date
2016-04-17, 1395/01/29
Ethics committee reference number
IR.SBMU.RAM.REC1395.71
Health conditions studied
1
Description of health condition studied
After paine
ICD-10 code
z39
ICD-10 code description
postpartum care and examination
Primary outcomes
1
Description
seventry of pain
Timepoint
Before intervention - 2 hours after delivery - then every 6 hours for 24 hours
Method of measurement
Numerical Analogus Scale
Secondary outcomes
1
Description
the Number of additinal analgesic
Timepoint
2hours after delivery then every 6 hours numerical Analogus SCALE
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: The samples were given a Melisa oral capsule containing 150 mg of dried extracts of Melisa ( produced in goldaro company ), two hour after delivery then every 6 hours for 24 hours.
Category
Treatment - Drugs
2
Description
control group:The samples were given a Mefenamic Acid oral capsule 250mg ,two hour after delivery then every 6 hours for 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Askarieh Hospital
Full name of responsible person
Mojgan Naderi
Street address
Askarieh Hospital, Soroush st, Esfahan
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Beheshti University of Medical Sciences(SBUMS)
Full name of responsible person
Dr. Mahrokh Dolatian
Street address
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
City
Tehran
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 of Shahid Beheshti University of Medical Sciences(SBUMS)
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 of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
PHD of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
+98 21 2219 0684
Email
gozgoli@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gity Ozgoli
Position
PHD of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Niayesh Highway, Valiasr St, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
+98 21 2219 0684
Email
gozgoli@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)