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: The effect of oral Calendula officinalis on the wound healing in second degree burn

Protocol summary

Summary
Objective:care/ wound healing.Design of the study:randomized,double blind,controlled,single-centered,stage two trials.study population:patients with burn.Entrance criteria:have second degree burn.Exit criteria:Unwillingness to continue to study.Sample size:60 Intervention or interventions After receiving a letter of intent and posting a questionnaire, the intervention group will receive, in addition to the usual treatments, for 2 weeks, once a day, a capsule containing 2 grams of flower extract and the capsule control group containing the placebo. The wound condition is examined using the Bets-Jensen standard on the first, seventh and fifth days of the study

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070334880N1
Registration date: 2017-09-20, 1396/06/29
Registration timing: na

Last update:
Update count: 0
Registration date
2017-09-20, 1396/06/29
Registrant information
Name
SORAYA REZAEE
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 864173638
Email address
soraya.rezaee@arakmu.ac.ir
Recruitment status
Not enough for processing
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: The effect of oral Calendula officinalis on the wound healing in second degree burn
Public title
- The effect of Calendula officinalis on second-degree burns-
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Second degree burns; Burn percentage between 15 and 50% (based on Landau Browder chart); The samples should be between the ages of 18 and 55 years; Over 48 hours of burn injury; In the burn area, be hospitalized; Do not be fast; Participate in the study; Not pregnant; Do not breastfeed; Lack of underlying diseases such as diabetes, cancer, or infectious diseases; Do not abuse substance (alcohol, narcotics, and sedation). Exclusion criteria: Unwillingness to continue to study; Release of patient; Transfer to another department; Patient's death
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
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
Use the blocking technique

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ََArak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street
City
Arak
Postal code
3848176941
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ARAKMU.REC.1396.44

Health conditions studied

1

Description of health condition studied
second degree burn
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified

Primary outcomes

1

Description
wound healing
Timepoint
In the days of 1,7 and 15
Method of measurement
BATES-JENSEN WOUND ASSESSMENT TOOL

Secondary outcomes

1

Description
Burn percentage
Timepoint
In the days of 1,7 and 15
Method of measurement
Landau Brothers Chart

2

Description
Burn depth
Timepoint
In the days of 1,7 and 15
Method of measurement
BATES-JENSEN WOUND ASSESSMENT TOOL

Intervention groups

1

Description
Intervention group 1: Calendula, capsule of 500 mg orally, twice daily for fourteen days
Category
Placebo

2

Description
Control group: Starch,A capsule of 500 mg orally, twice daily for fourteen days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
soraya rezai
Street address
Valiasr Hospital Vali Asr Square arak iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojtaba Bagheri
Street address
Sardasht,Arak University of Medical Sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
SORAYA REZAEE
Position
Student/Masters
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3502
Fax
Email
SORAYA.REZAEE@ARAKMU.AC.IRSORAYAREZAI71@YAHOO.COM
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Kobra Rahzani
Position
PHD of nursing
Other areas of specialty/work
Street address
Sardasht- Arak University of Medical Sciences
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3502
Fax
Email
k.rahzani@yahoo.com
Web page address
www.arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
SORAYA REZAEE
Position
Student/Masters
Other areas of specialty/work
Street address
Sardasht.Arak University of Medical Sciences
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3502
Fax
Email
SORAYA.REZAEE@ARAKMU.AC.IR SORAYAREZAI71@YAHOO.COM
Web page address
www.ararkmu.ac.ir

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
empty
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