Evaluation of the effect of mixed ethanolic extract (Black seed and Dill seeds) on some parameters of postpartum maternal physical health compared with mefnamic acid
Determination of the effect of mixed ethanolic extract (Black seed and Dill seeds) compared with mefenamic acid on some parameters of postpartum maternal and neonatal physical health
Design
Two arm parallel group randomised clinical trial with double-blinded postoperative care
Settings and conduct
Female with term pregnant referred to Emam Sajad hospital divided into two groups of mixed ethanolic extract (Black seed and Dill seeds) and mefenamic acid for 3 days. Patient and nurse do not know about kind of medicine.
Participants/Inclusion and exclusion criteria
Female with term pregnancy and stable hemodynamic status
Intervention groups
In intervention group A: The black seeds and dill seeds are each washed separately and after drying in the shade, the plant will be milled, and extracted with 70% ethanol for 48 hours by maceration technique. The hydroalcoholic solution is then separated by filter paper from the plant particles and the remaining ethanol is collected by a rotary machine. The residue of the extract is kept at 37 ° C for evaporation. Finally, the dried extract is stored at 20 ° C for testing in the clinical laboratory. The selective dose of the dried extract in the combined capsule in the present study was 500 mg of black seed and 400 mg of dill daily. It should be noted that the relevant dose has been selected after studying the previous articles, evaluating human safety and the opinion of the consultant professor.
In intervention group B: Mefenamic acid will be completely similar in appearance to group A and will be administered in the same manner. Mefenamic acid will be administered 250 mg every six hours during the first three days after delivery.
Main outcome variables
Hemorrhage, pain and breast feeeding after delivery
General information
Reason for update
Acronym
PPH
IRCT registration information
IRCT registration number:IRCT20200214046492N1
Registration date:2020-04-01, 1399/01/13
Registration timing:prospective
Last update:2020-04-01, 1399/01/13
Update count:0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Elaheh Foroutani fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3229 3163
Email address
vestal2475@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of mixed ethanolic extract (Black seed and Dill seeds) on some parameters of postpartum maternal physical health compared with mefnamic acid
Public title
Evaluation of the effect of mixed ethanolic extract (Black seed and Dill seeds) on pain and post partum hemorrage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestation age 38-42 week
Singletone pregnancy
NVD
Mother age 15-44
iranian
spontaneous placental remove
no previous surgery
no spinal or opium
HB>8
no ROM >12
no opium addiction
no sensetive to herbal
no percipitate labor or prolonge labor
BMI 18/5-29/5
Fetal weight 2500-4000
no disease in mother
no operative vaginal delivery
no 3,4 degree laceration
no use warfarin,banzodiazepin,ASA,Alcohol,heparin
Exclusion criteria:
no breast feeding
no cooprative patient
use another herbal
no sensetive to herbal
severe dissease in mother and neonate
Age
From 15 years old to 44 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The study units will be divided into groups A and B on the basis of random allocation by computer random generation. The appearance of the drug and placebo will be quite similar. The participants and the researcher are completely unaware of the drugs, but the pharmacist is aware (double-blinded).
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and nurse do not know kind of medicine. All patient was taken the same shape medicine.
Placebo
Not used
Assignment
Parallel
Other design features
Use 2 ethanol herbal in one capsule
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Faculty of medicine, Medical campus, Next to Imam Sajjad Hospital, Shahid Dr. Ghorban Ali Jalil Ave
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Approval date
2020-02-13, 1398/11/24
Ethics committee reference number
IR.YUMS.REC.1398.153
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage and pain
ICD-10 code
O72.1
ICD-10 code description
Other immediate postpartum hemorrhage
Primary outcomes
1
Description
Postpartum hemorrhage
Timepoint
Before study then first hour till 6hrs then till 3days
Method of measurement
Iranian GYN and OB protocol
2
Description
Pain
Timepoint
Before study then first hour till 6hrs then till 3days
Method of measurement
Visual Analogue Scale Score
Secondary outcomes
1
Description
Breast feeding
Timepoint
Three days in the time of intervention then 2 weeks later
Method of measurement
Urination and defication of neonate
2
Description
Liver function
Timepoint
After intervention
Method of measurement
Blood test
3
Description
Complete Blood Count
Timepoint
After intervention
Method of measurement
Blood test
4
Description
Renal function
Timepoint
After intervention
Method of measurement
Blood test
5
Description
Sodium, Potassium
Timepoint
After intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group A: The black seeds and dill seeds are each washed separately and after drying in the shade, the plant will be milled, and extracted with 70% ethanol for 48 hours by maceration technique. The hydroalcoholic solution is then separated by filter paper from the plant particles and the remaining ethanol is collected by a rotary machine. The residue of the extract is kept at 37 ° C for evaporation. Finally, the dried extract is stored at 20 ° C for testing in the clinical laboratory. The selective dose of the dried extract in the combined capsule in the present study was 500 mg of black seed and 400 mg of dill daily. It should be noted that the relevant dose has been selected after studying the previous articles, evaluating human safety and the opinion of the consultant professor.
Category
Treatment - Drugs
2
Description
Intervention group B: Mefenamic acid will be completely similar in appearance to group A and will be administered in the same manner. Mefenamic acid will be administered 250 mg every six hours during the first three days after delivery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Sajad Hospital
Full name of responsible person
Zahra Zare
Street address
Emam Sajad Hospital, Saheli Str
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3222 0163
Email
vestal2475@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Ali Mosavizadeh
Street address
Vice chancellor of research, Kohgiluyeh and Boyer-Ahmad University of Medical Sciences, Shahid Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
21345-35671
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
vestal2475@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Elaheh Foroutanifard
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Sajad Hospital, Saheli Str
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3322 0116
Email
vestal2475@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Bazarganipoor
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Family Health
Street address
Emam Sajad Hospital, Saheli Str
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3322 0162
Email
vestal2475@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Elaheh Foroutanifard
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam Sajad Hospital, Saheli Str
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3322 0162
Email
vestal2475@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about main outcomes of the study
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Researchers in universities and scientific and research centers
Under which criteria data/document could be used
In order to improve the control of postpartum hemorrhage and pain, and subsequent researches, and with the permission of the authors
From where data/document is obtainable
Department of Obstetrics and Gynecology of Yasuj university of medical sciences
What processes are involved for a request to access data/document
Sending the request in writing or by email to the authors