Considering the importance of postpartum pains reduction for better care and effective interaction between mother and baby after delivery, the aim of this study is to compare the effect of Ginger-Lavender capsule with Mefenamic Acid on postpartum pains in women referred to Valiasr Hospital in Fasa in 1400.
Design
Controlled clinical trial work, with parallel groups, triple-blind, randomized, phase 3 on 94 women, Excel software for randomization
Settings and conduct
After sampling from women referring to the maternity ward of Valiasr Hospital in Fasa based on the entry criteria, sampling will be done continuously and purposefully. The method of coding on pharmaceutical bags is used for blinding. Researcher, samples and statistics consultants are blind.
Participants/Inclusion and exclusion criteria
Entry criteria:15 to 44 years old; Minimum literacy; Vaginal delivery; 37 to 42 weeks of gestational age; Moderate to severe postpartum pain; No instrumental delievery; No 3rd and 4th degree rupture; No history of chronic/systemic diseases; No history of C-section surgery; No use of epidural/spinal anesthesia; No drug addiction; No history of allergies to herbal medicines; Successful breastfeeding; Singleton delivery and healthy baby; Have no complications of childbirth; 2nd delivery or more
Exit criteria:Mother unwillingness; No pain relief with study drugs; Sensitivity to the drug; Use chemical and herbal analgesics other than studies; Suffers from postpartum complications during the intervention; Have a history of more than one delivery.
Intervention groups
2 hr after delivery, Pain intensity is recorded in two groups(Ginger-Lavender and Mefenamic Acid) by VAS, prior the intervention and one hour after. 300 mg capsules of "Ginger-Lavender" and 250 mg of "Mefenamic Acid" 4 times a day for one day after delivery. At the end, average pain will be evaluated.
Main outcome variables
Severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200525047565N3
Registration date:2021-11-12, 1400/08/21
Registration timing:prospective
Last update:2021-11-12, 1400/08/21
Update count:0
Registration date
2021-11-12, 1400/08/21
Registrant information
Name
Sharareh Jannesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
shararehjannesari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of the effect of" Ginger-Lavender" capsule with" Mefenamic Acid" on postpartum pain
Public title
Comparing of the effect of" Ginger-Lavender" capsule with" Mefenamic Acid" on postpartum pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be 15 to 44 years old
Have minimum literacy
Have vaginal delivery
Be in 37 to 42 weeks of gestational age
Complain of moderate to severe postpartum pain
Do not have the delivery with the help of tools
Have no 3rd and 4th degree rupture
No history of chronic or systemic diseases such as diabetes or high blood pressure
Have no history of cesarean section and intra-abdominal surgery
Do not use epidural and spinal anesthesia during labor
Do not have any drug addiction
Have no history of allergies to herbal medicines
Successful breastfeeding has begun
Have a singleton delivery and healthy baby
Have no complications of childbirth such as bleeding, fever and high blood pressure
Have a history of more than one delivery
Exclusion criteria:
Age
From 15 years old to 44 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
First, sampling is selected based on the number of targets from the women referring to the maternity ward of Valiasr Hospital in Fasa. After introducing herself, the researcher will explain to the participants the goals and how to implement the research. Then, if they have the conditions to enter the study, they are divided into two groups of capsule users "Ginger - Lavender" and "Mefenamic Acid" by accidental assignment using Excel software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The blinding was done in such a way that the capsule containing Ginger-Lavender was prepared in exactly the same way as the Mefenamic Acid capsule and coded. Only the Pharmacogenesis Consultant is aware of its contents and codes, and the researcher and participants in the research and data analyzer are unaware of it. In this way, the study will be done in triple blind ways.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research, School of Pharmacy, Nursing, Midwifery of Shahid Beheshti University
Street address
School of Nursing and Midwifery, Opposite to Rajaee Heart Hospital, Valiasr Street, Intersection of Niayesh Highway, Tehran. Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.167
Health conditions studied
1
Description of health condition studied
postpartum pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
severity of pain
Timepoint
2 hours after delivery, To be evaluated every 6 hours before and one hour after the intervention until 24 hours after delivery.
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: "Ginger-lavender" group of 300 mg capsules containing 250 mg of ginger and 50 mg of Lavender extract prepared in Shahid Beheshti School of Traditional Medicine 4 times a day (every 6 hours) from 2 hours after delivery. They will receive up to 24 hours. Basic pain (before the intervention) and then one hour after each intervention is measured with a visual analogue scale.
Category
Treatment - Drugs
2
Description
Control group: "Mefenamic Acid" group will receive 250 mg "Mefenamic Acid" capsules of Amin Company daily (one every 6 hours) from 2 hours after delivery until 24 hours later. Basic pain (before the intervention) and one hour after each intervention is measured with a visual analogue scale.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Nadereh Ashkan
Street address
Valiasr Hospital, Ibn Sina Square, Fasa, Fars
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5333 4020
Email
info@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Arabi St, Yemen St, next to Ayatollah Taleghani Hospital, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 29901
Email
info@sbmu.ac.ir
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
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
sharareh Jannesari
Position
Midwifery Instructor
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, in front of Rajaee Heart Hospital, Vali-Asr St, Intersection of Niyayesh Highway, tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
shararehjannesari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sharareh Jannseari
Position
Midwifery Instructor
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, in front of Rajaee Heart Hospital, Vali-Asr St, Intersection of Niyayesh Highway, tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
shararehjannesari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sharareh Jannesari
Position
Midwifery Instructor
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, in front of Rajaee Heart Hospital, Vali-Asr St, Intersection of Niyayesh Highway, tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
Shararehjannesari@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
The data remains confidential to the researcher at first.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
This research is to observe the effect of “Ginger-Lavender” Capsule to reduce postpartum after-pains
When the data will become available and for how long
After the article is published in the desired journal is available.
To whom data/document is available
Everyone who is interested in the article.
Under which criteria data/document could be used
To increase the quality of women's lives and to use more herbal medicine.
From where data/document is obtainable
Email the corresponding author.
What processes are involved for a request to access data/document
Explain the reasons for requesting an article in the email.