The aim of this study is comparing the changes of VAS score and BRS before receiving green tea and 8 hrs after operation. This clinical trial is performed on patients undergoing tibia surgery in Poorsina hospital in Rasht, Iran. After obtaining a history, physical exam and 12 lead ECG, venous blood is obtained for baseline biochemical serum measurements, as well as CBC- ALT- AST- BUN- Cr-ALKP. The inclusion criteria are the patient aged between 30-65 years old candidate for tibia fracture surgery daily consumed of black tea are not more than 2 tea bags or 4g loose tea/day. The exclusion criteria are cognitive or psychiatric disorders; history of any drug abuse, hepatic and renal diseases; pregnancy and breast feeding. All participants meeting inclusion criteria provided with informed consent. In this double blind clinical trial participants are randomly assigned to two groups of green tea and placebo by triple blocks. The anesthesia method and pain control are the same in two groups, green tea (n=30) and placebo (n=30). In green tea group, patients receive a cup of green tea 2hrs before and 6hrs after operation. In two groups pain severity and relaxation are evaluated based on VAS score and BRS by a person who is not aware of the type of drink .Then the results will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504076186N9
Registration date:2015-04-09, 1394/01/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-09, 1394/01/20
Registrant information
Name
Bahram Naderi Nabi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 4600
Email address
naderi_bahram@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-12-10, 1394/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Green Tea on Post operation Relaxation and Pain in Tibia Surgery
Public title
Effect of Green Tea on Relaxation and Pain
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria are the patient aged between 30-65 years old candidate for tibia fracture surgery; daily consumed of black tea are not more than 3 tea bags or 4 diluted ones.The exclusion criteria are cognitive or psychiatric disorders; history of any drug abuse; hepatic and renal diseases; pregnancy and breast feeding.
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences