1. Home
  2. Approved trials
  3. » فارسی

The effect of (Cuminum cyminum,Foeniculum and Anethum graveolens dhi ) capsule on a postpartum pain

Protocol summary

Study aim
Determining the effect of the capsule (cumin, dill, and fennel) on postpartum pain
Design
The clinical trial has control and intervention group, three-way blind, randomized, on 100 patients by Excel software
Settings and conduct
The intervention is performed in the postpartum ward of Shohadae 15 Khordad Hospital in Varamin, in two groups. According to the ward’s regulation, women receive a 250 mg mefenamic acid capsule. In addition to the mefenamic acid capsule, one capsule (cumin, dill, and dill)/placebo will be given. For blinding, the intervention is performed by a researcher (midwife with similar work experience).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Normal vaginal delivery, Gestational age 37-42 weeks, Live child,Weight of baby born between 2500-4000 grams, Moderate or severe postpartum pain. Exclusion criteria: Severe bleeding, grade 3 or 4 of perineal rupture, History of allergies to medicinal plants
Intervention groups
Herbs (cumin, dill, and fennel) will be purchased and after approving the identification, by soaking in ethanol alcohol at 96 degrees method, they will be extracted. Then the plant extraction (cumin, dill, and fennel) will be mixed with corn starch and filled in 500 mg capsules. Each capsule contains 300 mg prepared extraction from 100 mg of each plant extract .The placebo capsule contains dry bread and will be prescribed in a similar dose and capsule in the control group. These capsules are prescribed every 8 hours, 2 to 24 hours after normal delivery for mothers who meet the inclusion criteria and are categorized in the Intervention and control groups.
Main outcome variables
Severity and duration, and time of postpartum pain relief

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211130053228N1
Registration date: 2022-03-05, 1400/12/14
Registration timing: prospective

Last update: 2022-03-05, 1400/12/14
Update count: 0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Masoome Tajik
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3626 4863
Email address
masoome.tajik@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of (Cuminum cyminum,Foeniculum and Anethum graveolens dhi ) capsule on a postpartum pain
Public title
The effect of (Cuminum cyminum,Foeniculum and Anethum graveolens dhi ) capsule on a postpartum pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
normal vaginal delivery. The gestational age between 37-42 weeks The live single neonate with cephalic presentation The birth weight 2500-4000 grams. moderate to severe postpartum pain based on Visual scale of pain The placental removal are is spontaneous.
Exclusion criteria:
Severe postpartum hemorrhage. Prolonged delivery and use vacium. Analgesia and epidural anesthesia, spinal anesthesia during labor Addiction History of systemic diseases Grade 3 or 4 perineal laceration History of allergies to medicinal plants
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment method using Excel software, in one of two groups of intervention and control
Blinding (investigator's opinion)
Triple blinded
Blinding description
For blinding, the intervention is performed by the researcher's colleague (midwife with similar work experience) and the researcher is not aware of the intervention and control groups. The same and with codes A and B will be prepared and coded by Pharmaco Gnosist consultant. The researcher will not know the codes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Schools of Pharmacy, Nursing and Midwifery - Shahid Beheshti University of Medical Sciences
Street address
Unit 17،Persepolis building،in front of Madani clinic، Shahid Rajaei Street
City
Varamin
Province
Tehran
Postal code
33718-38975
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.212

Health conditions studied

1

Description of health condition studied
postpartum pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The severity of postpartum pain
Timepoint
1-2-3-4-5-6-12-18-24 hours after delivery
Method of measurement
Pain ruler

2

Description
Duration of pain after delivery
Timepoint
1-2-3-4-5-6-12-18-24 hours after delivery
Method of measurement
Timer

3

Description
Time of pain relief after delivery
Timepoint
1-2-3-4-5-6-12-18-24 hours after delivery
Method of measurement
Timer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Herbs (cumin, dill, and fennel) will be purchased and after approving the identification, by soaking in ethanol alcohol at 96 degrees method, they will be extracted. Then the plant extraction (cumin, dill, and fennel) will be mixed with corn starch and filled in 500 mg capsules. Each capsule contains 300 mg prepared extraction from 100 mg of each plant extract. This capsule is prescribed every 8 hours, 2 to 24 hours after normal delivery for mothers who meet the inclusion criteria. The mother will also given mefenamic acid capsule.
Category
Treatment - Drugs

2

Description
Control group: The placebo capsule will be prepared by the Pharmacognosy Research Center of Shahid Beheshti University of Medical Sciences and will be prescribed in the identical dose and capsule in the control group. mother will also given mefenamic acid capsule.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
15 Khordad shohadan Varamin Hospital
Full name of responsible person
Masoome Tajik
Street address
Entrance of Varamin city
City
Varamin
Province
Tehran
Postal code
3371461916
Phone
+98 21 3502 3337
Email
masoometajik5@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Chamran Highway, Yemen St. - Shahid Arabi St. next to Ayatollah Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
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
Social Security Organization
Full name of responsible person
Masoome Tajik
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Entrance of Varamin city- Shohada15 Khordad Varamin Hospital
City
Varamin
Province
Tehran
Postal code
3371461916
Phone
0098 21 35023337-9
Email
massometajik5@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahboubeh Ahmadi Dolabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vali Asr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
mah1372@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Social Security Organization
Full name of responsible person
Masoome Tajik
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Entrance of Varamin city- Shohada15 Khordad Varamin Hospital
City
Varamin
Province
Tehran
Postal code
3371461916
Phone
0098 21 35023337-9
Email
masoometajik5@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...