Effect of portulaca Oleracea Capsule on Postpartum pain and hemorrhage volume
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment. will be done on 106 fertilized mothers who will naturally be delivered to the maternity ward of Shahid Akbar Abadi Clinic, affiliated to Iran University of Medical Sciences in 1396the researcher and the statistical analyst, are not aware of any individuals located in the studied groups.Mothers were randomly divided into two groups (A) and Group B (placebo) by random sampling with Excel software.
Participants/Inclusion and exclusion criteria
Vaginal delivery, noliparity,the reproductive ages,the possibility of taking on oral drug,the lack of sensitivity to herbal medicine,non use of drug addiction and no deed to have surgery delivery
Intervention groups
he intervention group took parpin ala capsules each containing 500 mg portulaca oleracea extracts. The control group was treated with the same course and duration; instead, they took placebo for two whole menstruation cycles
Main outcome variables
Hemorrhage Volume, Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180428039454N1
Registration date:2018-05-31, 1397/03/10
Registration timing:retrospective
Last update:2018-05-31, 1397/03/10
Update count:0
Registration date
2018-05-31, 1397/03/10
Registrant information
Name
Samira Shiralinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5614 2600
Email address
shiralinezhad.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-13, 1396/12/22
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Parpin Ala Capsule on the Postpartum Pain and Hemorrhage Volume
Public title
Effect of Portulaca Oleracea Capsule on the Postpartum Pain and Hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Vaginal Delivery
Nolipar
The reproductive ages
The possieility of taking an oral drug
Lack of history of medical and psychological disease
The lack of sensitivity to herbal medicine
Non-use of drug addiction
No need to have surgery after delivery
Exclusion criteria:
Obesity and BMI above 35
Cesarean /section
Multiple births
Polyhydramnios
Pre_eclampsia
The lower the hemogolobin of 9
Age
From 15 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Mothers were randomly divided into two groups (A) and Group B (placebo) by random sampling with Excel software. In both groups, mefenamic acid is given as a routine diphtheria. In group A or in the intervention group, half an hour after receiving mefenamic acid, the capsule is given purpel, and in group B, which is the control group, half an hour after receiving mefenamic acid in the placebo capsule It will be given.
Blinding (investigator's opinion)
Double blinded
Blinding description
Two arm parallel group randomised trail with blinded postoperative care and outcome assissment. So that the study group and researcher are not aware of any individuals located in the studied groups. Mothers were randomly divided into two groups (A) and Group B (placebo) by random sampling with Excel software. In both groups, mefenamic acid is given as a routine dwelling.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of iran University of Medical Sciences
Street address
No 87.panahi Ave. Mahdie Town.eslamshahr City
City
Eslamshahr
Province
Tehran
Postal code
3313661933
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9411373009
Health conditions studied
1
Description of health condition studied
postpartum pain
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination
2
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
O72.1
ICD-10 code description
Other immediate postpartum hemorrhage
Primary outcomes
1
Description
After pain delivery
Timepoint
the first 24 hours after delivery ,Half an hour after the first and second follow up (Every 12 hours one number capsul 500 mgr).
Method of measurement
Visual analoge scale
2
Description
Hemorrhage volume
Timepoint
Weight gain of the pads after each change during the first 24 hours after delivery
Method of measurement
Japanese Digital scales
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention proup 500 mgr parpin ala capsul, the first 24 hours after delivery ,Every 12 hours one number
Category
Treatment - Drugs
2
Description
Control group:A placebo capsule containing corn starch weighing about 10 grams carbohydrates (one serving of bread),the first 24 hours after delivery ,Every 12 hours one number
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar abadi hospital
Full name of responsible person
Samira shiralinezhad
Street address
Molavi Road. Akbar abadi hospital
City
Tehran
Province
Tehran
Postal code
3313661933
Phone
+98 21 5614 2600
Email
Www.samira.shiralinezhad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem malakuti
Street address
Hemmat Road.iran university of medical sciences
City
Tehran
Province
Tehran
Postal code
3313661933
Phone
+98 21 86601
Email
Www.samira.shiralinezhad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira shiralinezhad
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No87.panahi Ave.mahdie town.eslamshahr city
City
Eslamshahr
Province
Tehran
Postal code
3313661933
Phone
+98 21 5614 2600
Email
Www.samira.shiralinezhad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira.shiralinezhad
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No87.panahi Ave.mahdie town.eslamshahr city
City
Eslamshahr
Province
Tehran
Postal code
3313661933
Phone
+98 21 5614 2600
Email
Www.samira.shiralinezhad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira shiralinezhad
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No87.panahi Ave.mahdie town.eslamshahr city
City
Eslamshahr
Province
Tehran
Postal code
3313661933
Phone
+98 21 5614 2600
Email
Www.samira.shiralinezhad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD