Objectives: To evaluate the effect of Eremostachys laciniata herbal extract on mitigation of pain after apandectomy surgery
Design: Clinical trial study
Setting and conduct: Randomized clinical trial study
Participants including major eligibility criteria: 120 patients underwent appendectomy will be evaluated.
Intervention:The control group will receive pethidine before the surgery and placebo 24 hours after surgery every 12 hours and the case group will receive pethidine before the surgery and Eremostachys laciniata herbal extract 24 hours after surgery every 12 hours.
Main outcome: Pain severity score at different time interval after surgery- recovery, 1, 2, 3, 4, 8, 16, 24 hours after entering the ward will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310185605N4
Registration date:2014-01-16, 1392/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-16, 1392/10/26
Registrant information
Name
MOHAMAD GOLDUST
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133614711
Email address
medres@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug applied research center, Tabriz university of medical sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect Eremostachys laciniata herbal extract on mitigation of pain after apandectomy surgery
Public title
The effect of Eremostachys laciniata herbal extract on mitigation of pain after apandectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 120 patients underwent appendectomy will be evaluated.
Exclusion criteria: Suffering from any underlying disease; history of mental disorder; consumption of special medicines including ecstasies were regarded as exclusion criteria.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tabriz university of medical sciences
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2013-03-12, 1391/12/22
Ethics committee reference number
9225
Health conditions studied
1
Description of health condition studied
Appendectomy
ICD-10 code
K35
ICD-10 code description
acute appendicitis
Primary outcomes
1
Description
Pain severity
Timepoint
Begining of the study
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The case group received pethidine before the surgery and Eremostachys laciniata 24 hours after surgery every 12 hours.
Category
Treatment - Drugs
2
Description
The control group received pethidine before the surgery and placebo 24 hours after surgery every 12 hours.
The placebo suppositories contained starch and cacao butter.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of surgery, Sina hospital
Full name of responsible person
Dr Hemmat Maghsoudi
Street address
5166614711, Azadi street, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Drug applied research center, Tabriz university of medical sciences
Full name of responsible person
Dr Abbas Delazar
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug applied research center, Tabriz 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
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Jafar Bohlouli Oskouei
Position
Resident in general surgery
Other areas of specialty/work
Street address
5166614711, University street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1545 2206
Fax
Email
Drmgjgoldust@yahoo.com
Web page address
Drmgjgoldust@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Hemmat Maghsoudi
Position
Professor in general surgery
Other areas of specialty/work
Street address
5166614711, Azadi street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1545 2206
Fax
Email
Maghsoudih@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)