Determine ginger gel effectiveness compared to gelofen in relieving pain after tooth extraction
Design
A clinical study will be conducted on patients in the dental clinic.
The sample size was 60 (30 persons per group).
Before treatment, patients are given an explanation for the current research, and after receiving the necessary information, patients are given written consent for treatment. Patient treatment is done in a single session by a specific dentist. After reaching complete anesthesia, the tooth was removed by forceps. The selection of the drug was carried out in a series of 60 envelopes containing 30 envelopes containing gelofen capsules (400 mg, Tehran drug) and 30 envelopes containing ginger capsules (250 mg Zinatuma capsule, drug flower) And codes A and B are inserted. The fact that the researcher does not know the prescribed prescription is to encode and give the medication to one of the secretaries. Patients are examined and examined by the researcher for at least 3 days after removal of the tooth.
Settings and conduct
Blind study is done. The patient and the researcher are not aware of the type of medication received.The drugs are placed in the envelope by the secretary.
Participants/Inclusion and exclusion criteria
Persons aged 18 to 65 years
No use of analgesic or drug treatment 4 hours before referral
No history of food allergy, certain medication
Exit criteria
Need for surgical intervention
Pregnant and lactating women
Intervention groups
Ginger capsule 250 mg, 12 tablets every 6 hours One tablet is given for 72 hours
Main outcome variables
Less use of chemical drugs: reduce side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171206037770N1
Registration date:2018-08-24, 1397/06/02
Registration timing:retrospective
Last update:2018-08-24, 1397/06/02
Update count:0
Registration date
2018-08-24, 1397/06/02
Registrant information
Name
jahed faridi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 5199
Email address
jahedfaridi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-06-21, 1397/03/31
Trial completion date
empty
Scientific title
A comparative study on the effect of ginger and gelofen on postoperative pain after tooth extraction
Public title
A comparative study on the effect of ginger and gelofen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 18 to 65 years old come to the tooth exit
No use of analgesics or other traditional drugs 4 hours before the visit
No drug use 4 hours before the visit
No history of food allergy, certain medication
Exclusion criteria:
Patients with history of cardiovascular, hormonal, blood, electrolyte, liver and kidney disease
No lesion or periapical radiographic examination
Need for surgical intervention
Pregnant and lactating women
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Referring to the conditions for entry into the study, the subject of the research will be described to them, and if the form of informed consent is completed, the random allocation of the block with the quadruple blocks is assigned to one of the two intervention and control groups..
RUN 1:
A A B B
RUN 2:
A B A B
RUN 3:
B A A B
RUN 4:
B A B A
RUN 5:
B B A A
RUN 6:
A B B A
Blinding (investigator's opinion)
Double blinded
Blinding description
The selection of the drug was done in this way, with 60 envelopes of 30 envelopes containing gelofen capsules and 30 envelopes containing ginger capsules ( capsules Zintoma ) and codes A and B inserted. The fact that the researcher does not know the prescribed prescription is to encode and give the medication to one of the secretaries. Patients are examined and examined by the researcher for at least 3 days after removal of the tooth
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
Town of Imam Hussein, a subsidiary of No. 17
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591817719
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.YUMS.REC.1396.160
Health conditions studied
1
Description of health condition studied
Tooth extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain After Tooth Extraction
Timepoint
Hour 6,12,24,48,72
Method of measurement
The pain rate was Visual Analogue Scale from 1 to 10 (a symptom of painlessness and number 10, severe pain, 1 painless, 2-4 mild pain, 5-7 average pain, 10-8 severe pain). And recorded
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 envelopes containing ginger capsules (250mg Zinatma capsule, drug gol).12 capsule capsules are given at intervals of every 6 hours. Control group: 30 envelopes containing gelofen capsule (400mg, Tehran drug), 12 capsule capsules at intervals of 6 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ashraf Health Care Center
Full name of responsible person
Behrouzpour karam
Street address
No. 2 Bahonar Street ,Shahid Ashraf Health Center
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-54661
Phone
+98 74 3222 2713
Email
jahedfaridi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Marie oriad
Street address
Motahhari Blvd, University of Medical Sciences, Vice Chancellor for Research
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591817719
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
jahedfaridi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
jahedfaridi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 17, Western Suburbs,Imam Hossein Town
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591817719
Phone
+98 74 3333 5199
Email
jahedfaridi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj medical science
Full name of responsible person
Ayat allah poozesh
Position
Dentist specialist non-faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Teacher's Street No. 2
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591796987
Phone
+98 74 3322 4635
Email
poozeshAyat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
jahedfaridi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 17,Shahid Fazli Alley,Imam Hossein Town
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591817719
Phone
+98 74 3333 5199
Email
jahedfaridi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because it's confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data include patient name, patient gender, visual acuity scale, possible side effects of medication
When the data will become available and for how long
After printing the article
To whom data/document is available
In terms of discretion University
Under which criteria data/document could be used
Based on the conditions that the university determines
From where data/document is obtainable
Yasouj University of Medical Sciences, Research department
What processes are involved for a request to access data/document