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Evaluating the effect of Dill (Anethum graveolens L.) seed essence on pain after cesarean delivery: a clinical trial

Protocol summary

Summary
In this study we studied the effect of Dill (Anethum graveolens L.) seed on pain intensity after cesarean section in patients undergoing spinal anesthesia. This study was a double-blind clinical trial conducted on pregnant women who were referred to the Hajar hospital and were eligible for the study, in 2015. The patients were selected by convenience sampling method and divided randomly into two groups. For randomization, 51 letter A and 51 letter B, written on separate cards were put in a bag and each patient picked up a card from the bag. Patients in intervention group received 10 cc Dill (Anethum graveolens L.) seed syrup, produced by Goldaroo company, one hour before and 30 minutes before spinal anesthesia and 30 minutes, one hour and two hours after spinal anesthesia. Patients in control group received 10 cc placebo syrup, produced by Goldaroo company one hour before and 30 minutes before spinal anesthesia and 30 minutes, one hour and two hours after spinal anesthesia. The placebo syrup contained all the components of syrup without any pharmaceutical composition or herbal extract. Inclusion criteria: Pregnant women undergoing caesarean section with ASA class I and II. Exclusion criteria: Any changes in anesthetic drugs; Complicated pregnancy; History of gastrointestinal and hemorrhagic disease; Type I and type II diabetes mellitus; Renal insufficiency; Hypertension; Drug allergy and allergy to Dill (Anethum graveolens L.) seed. Pain and vital signs including blood pressure, nausea and vomiting, heart rate, blood and narcotic use and any extra drugs (such as atropine and ephedrine) during surgery and at 30 minutes after spinal anesthesia, an hour, 4 hours and 12 hours after cesarean section were recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110112101N2
Registration date: 2017-03-21, 1396/01/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-21, 1396/01/01
Registrant information
Name
Parastoo Yarmohammadi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3352 4328
Email address
yarmohamadi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Shahrekord University of Medical Sciences
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2016-03-30, 1395/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Dill (Anethum graveolens L.) seed essence on pain after cesarean delivery: a clinical trial
Public title
Effect of Dill (Anethum graveolens L.) seed essence on pain after cesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women undergoing caesarean section with ASA class I and II. Exclusion criteria: Any changes in anesthetic drugs; Complicated pregnancy; History of gastrointestinal and hemorrhagic disease; Type I and type II diabetes mellitus; Renal insufficiency; Hypertension; Drug allergy and allergy to Dill (Anethum graveolens L.) seed
Age
From 19 years old to 43 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
For randomization, 51 letter A and 51 letter B, written on separate cards were put in a bag and each patient picked up a card from the bag.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University Of Medical Science
Street address
Vice President of Research, Shahrekord University of Medical Sciences,Ayatollah Kashani Boulevard, Shahrekord , Chahar Mahal and Bakhtiari
City
Shahrekord
Postal code
8815713471
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
IR.SKUMS.REC.1394.159

Health conditions studied

1

Description of health condition studied
Pain after cesarean section
ICD-10 code
O29.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during pregnancy

Primary outcomes

1

Description
Pain
Timepoint
2 hours after anesthesia
Method of measurement
VAS (Visual analog Scale)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: patients in this group received 10 cc placebo syrup, produced by Goldaroo company one hour before and 30 minutes before spinal anesthesia and 30 minutes, one hour and two hours after spinal anesthesia. The placebo syrup contained all the components of syrup without any pharmaceutical composition or herbal extract.
Category
Treatment - Drugs

2

Description
Intervention group: patients in this group received 10 cc Dill (Anethum graveolens L.) seed syrup, produced by Goldaroo company, one hour before and 30 minutes before spinal anesthesia and 30 minutes, one hour and two hours after spinal anesthesia.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar hospital in Shahrekord
Full name of responsible person
Saeideh Shakeri
Street address
Hajar hospital, Parastar Street.
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Fatemeh Rafiei
Street address
Research Department, Shahrekord University of Medical Sciences,Ayatollah Kashani Boulevard, Shahrekord, Chahar Mahal and Bakhtiari
City
Shahrekord
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, Shahrekord University of Medical Sciences
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Gholamreza Shabanian
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Rahmatiyeh
City
Shahrekord University of Medical Sciences
Postal code
Phone
+98 38 3226 4830
Fax
Email
gshabanian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Parastoo Yarmohammadi
Position
MSc
Other areas of specialty/work
Street address
Vice chancellor for Research of Shahrekord University of Medical Sciences, Kashani Street, shahrekord.
City
Shahrekord
Postal code
8815713471
Phone
+98 38 3334 2414
Fax
+98 38333349506
Email
yarmohamadi@hlth.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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