In this clinical trial study the patients aging 35-50 years and candidate for elective hysterectomy have been investigated. the patients will be divided randomly in two groups (30 patient in each group). In intervention group the patients will receive eremostachys laciniata befoooour after anesthesia and in control group will take placebo. The severity of pain will be determind according to visual analog and the effect of drug on pain after surgery at the first day after the operation will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201115567N2
Registration date:2012-03-04, 1390/12/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-04, 1390/12/14
Registrant information
Name
Parvin Mostafa Gharabaghi
Name of organization / entity
Tabriz Universty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1556 1844
Email address
gharabaghip@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of preemptive administration cheledaghi extract on post operative pain in elective hysterectomy sections
Public title
Evaluation the efect preemptive administration cheledaghi extract on post operative pain in elective hysterectomy sections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 20 to 50 years who are candidate for elective hysterectomy. Exclusion criteria are: 1)age lower than 35 years 2)history of sever diseases and 3)duration of operation longer than 120 miniuts.
Age
From 35 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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
tabriz medicin university
Street address
golgasht streat
City
tabriz
Postal code
5138665793
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
9075
Health conditions studied
1
Description of health condition studied
Pain after hysterectomy
ICD-10 code
O75.9
ICD-10 code description
Complication of labour and delivery, unspecified
Primary outcomes
1
Description
Pain after hysterectomy section
Timepoint
24 hourse aftere surgery
Method of measurement
Visual Analogous Scale(VAS)
Secondary outcomes
1
Description
Need to analgesics
Timepoint
After surgery
Method of measurement
Patients' medical records
Intervention groups
1
Description
In first intenventional group supp placebo 24 h before surgery every 12 hours and 24h after surgery the supp of eremostachyc laciniata every 12h is adminesteration and the severity of pain with VAS and need to analgesy was determind also the serume level of PGE2 and Andorfin befour and aftere of surjury is analysed.
Category
Treatment - Drugs
2
Description
In second inventional group supp eremostachys laciniata is adminestered 24h before to 24h after surgery every 12h and the severity of pain with VAS and need to analgesia was determind.
Category
Treatment - Drugs
3
Description
In control group adminestration suup placebo 24h before to 24h after surgery every 12h and severity of pain with VAS and need to analgesia is analysed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
Baghshomal street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Womens Reproductive Health Research Center
Full name of responsible person
Tabriz University of Medical Sciences
Street address
South Artesh Ave., Alzahra hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Womens Reproductive Health Research Center
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
Poone Zamani
Position
MD
Other areas of specialty/work
Street address
Ghods pansion
City
Tabriz
Postal code
Phone
Fax
Email
www.poone zamani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parvin Mostafa Gharabaghi
Position
Gynecologist, fellowship of oncology
Other areas of specialty/work
Street address
Baghshomal street
City
East azarbayjan
Postal code
Phone
Fax
Email
gharabaghip@tbzmed.ac.irا
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Poone Zamani
Position
MD
Other areas of specialty/work
Street address
Ghods pansion
City
Tabriz
Postal code
Phone
Fax
Email
www.poone zamani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)