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The effect of Quercetin and Tannic acid on the treatment of phlebitis caused by venous catheters

Protocol summary

Summary
This randomized, single-blind placebo controlled clinical trial will be performed on 120 patients hospitalized with peripheral venous catheters in the internal ward of Vali-Asr Hospital, Birjand. The participants will be selected by convenience sampling and then randomly allocated to Quercetin, Tannic acid, combination or vehicle controlled groups (n=30 per group). The inclusion criteria will include having an IV catheter; age between 18 to 60 years; hospitalization in the internal ward for at least 72 hours; insensitivity to wound glue or medication; lack of skin diseases in the area of phlebitis; having at least one of the phlebitis symptoms (pain, redness, irritation). Exclusion criterion is discharge time of less than three days. Upon phlebitis onset, the peripheral catheter will be removed and posited in another place. Before the intervention, the severity of the phlebitis will be recorded based on a four-degree scale. Accordingly, those with a phlebitis severity from 1 to 3 will be randomly allocated to one of the study groups. The treatment will be carried out for 72 hours in 12-hour intervals in the area of phlebitis. The area will be checked every 12 hours for the presence of symptoms (warmth, redness, pain, or tenderness and swelling) and phlebitis intensity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015061422738N1
Registration date: 2016-01-17, 1394/10/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Sakineh Ghorbani
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3233 9085
Email address
s.ghorbani@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Quercetin and Tannic acid on the treatment of phlebitis caused by venous catheters
Public title
The Effect of Phytochemicals on the treatment of Phlebitis
Purpose
Treatment
Inclusion/Exclusion criteria
IInclusion criteria: having an IV catheter, gauge No. 20 (with all catheters of an essentially single brand), age between 18-60 years old, hospitalization in the internal medicine ward for at least 72 hours, no allergy to the drugs and the wound dressing, lack of blood transfusion, systolic blood pressure between 90 to 180 mmHg, no diabetes, no skin disease in the area of phlebitis, no pregnancy or lactation, having at least one phlebitis symptom (pain, redness, irritation) around the area, no chemical or herbal oil use for treatment of the phlebitis during the study, no history of allergy to the plants containing Quercetin or Tannic acid, using upper limbs for catheterization, using aseptic conditions for catheterization Exclusion criteria: patients discharged before three days, taking contraceptive drugs, patients with known comorbidities including hyper-coagulability states (e.g., anti-cardiolipin antibodies, anti-phospholipid antibodies, and vitamin C deficiency)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Ayatollah Ghaffari Street, Birjand University of Medical Sciences,
City
Birjand
Postal code
9717853577
Approval date
2015-06-08, 1394/03/18
Ethics committee reference number
ir.bums.1394.28

Health conditions studied

1

Description of health condition studied
phlebitis
ICD-10 code
T80.1
ICD-10 code description
Vascular complications following infusion, transfusion and therapeutic injection

Primary outcomes

1

Description
phlebitis
Timepoint
Before and 12 hours after treatment for 72 hours
Method of measurement
4 degree visual phlebitis scale

Secondary outcomes

1

Description
Dermal side effects
Timepoint
12 hours for 72 hours
Method of measurement
Observation

Intervention groups

1

Description
Use of Placebo (cream base) in the control group for 72 hours in 12-hour intervals in the area of phlebitis
Category
Placebo

2

Description
Use of Tannic acid 7% in intervation group for 72 hours in 12-hour intervals in the area of phlebitis
Category
Treatment - Drugs

3

Description
Use of Quercetin 2% in intervation group for 72 hours in 12-hour intervals in the area of phlebitis
Category
Treatment - Drugs

4

Description
Use the combination of Quercetin 2% and Tannic acid %7 in an intervention group for 72 hours in 12-hour intervals in the area of phlebitis
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Mohsen Foadoddini
Street address
Valiasr Hospital, Ayatollah Ghafari Street, Birjand
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology, Birjand University of Medical Sciences
Full name of responsible person
Gholam-Reza Sharifzaedh
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Street
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mohsen Foadoddini
Position
PhD in Physiology
Other areas of specialty/work
Street address
Ghaffari street
City
Birjand
Postal code
9717853577
Phone
+98 56 3239 5861
Fax
+98 985632440388
Email
foadmohsen@yahoo.com foadoddini@bums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohsen Foadoddini
Position
PhD in Physiology
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
971785577
Phone
+98 56 3239 5168
Fax
+98 56 3244 0388
Email
foadoddini@bums.ac.ir s.ghorbani@bums.ac.ir rezamood@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sakineh Ghorbani
Position
MSc Student
Other areas of specialty/work
Street address
Birjand University of Medical Sciences
City
Birjand
Postal code
9717853577
Phone
+98 56 3233 9085
Fax
+98 56 3244 0388
Email
s.ghorbani@bums.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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