Protocol summary

Summary
Oral mucositis is a common complication of chemotherapy in children with cancer. Mucositis, resulting in damage to the cells lining the mouth can cause painful inflammation and scarring. Savory Labiatae plants and Pierre traditional medicine as an analgesic and anti-infective effects have been noted. This study aimed to evaluate the efficacy of oral gel on oral ulcer pain and it is savory. The trial was double-blind and in phase two trials is to evaluate the effectiveness of oral gel Savory on 60 children undergoing chemotherapy Who were selected randomly and were divided into two groups of intervention and control groups and allocation was done in parallel. Children with a history of chemotherapy was 3-14 years and in the course of chemotherapy with oral ulcers and, if connecting to the ventilator Shdndantkhab were excluded from the study. In both treatment groups prior to treatment of mucositis continued, the intervention group and the control group Oral gel containing fennel extract 1% placebo gel after detection of oral mucositis twice daily for five days and topical used in the mouth. Since the beginning of the oral daily treatment for five days of lesion severity of oral mucositis using the WHO Ocher pain and pain intensity using a questionnaire recorded and compared results in the two groups that can be based on it is a less costly and less complications used to treat and prevent mucositis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061813691N7
Registration date: 2016-08-15, 1395/05/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-15, 1395/05/25
Registrant information
Name
Mohammad Arshadi Bostanabad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
arshadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-07-15, 1395/04/25
Expected recruitment end date
2016-12-15, 1395/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Satureja Hvrtnsz (carvacrol) on the severity of mucositis and pain in children undergoing chemotherapy: a randomized double-blind clinical trial. double-blind clinical trial.
Public title
Savory effect of mucositis and pain severity in children receiving chemotherapy: a randomized double-blind clinical trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Entry criteria: full consciousness, admitted to Tabriz Children's Hospital Hematology and Oncology, treatment with chemotherapy drugs cause mucositis (cisplatin, cyclophosphamide and Mtvtrvksayd); at least three years and a maximum of fourteen years, not having the recurrent infectious waste oral, diagnosis (ALL, lymphoma and neuroblastoma). Exclusion criteria: children and parents not wanting to continue working; the death of the child; the child is connected to the ventilator, continuous use painkillers or opiates to relieve pain.As a result the treatment will be compared in the two groups that could be a less costly and less complications used to treat and prevent oral ulcers.
Age
From 3 years old to 14 years old
Gender
Both
Phase
2
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 Tabriz University of Medical Sciences
Street address
Nursing and Midwifery Faculty، South Shariati Street، Tabriz
City
Tabriz
Postal code
5138947977
Approval date
2016-07-04, 1395/04/14
Ethics committee reference number
IR.TBZMED.REC.1395.282

Health conditions studied

1

Description of health condition studied
mucosit
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)

2

Description of health condition studied
pain
ICD-10 code
h57.1
ICD-10 code description
Ocular pain

Primary outcomes

1

Description
Mucositis
Timepoint
For five days following chemotherapy with oral ulcers
Method of measurement
Czech List View and questionnaire oral ulcers World Health Organization

Secondary outcomes

1

Description
pain
Timepoint
For five days following chemotherapy with oral ulcers
Method of measurement
Czech List View and tools Ocher pain

Intervention groups

1

Description
Following chemotherapy with oral ulcers detected in the intervention group adhesive gel containing 1% plant extract twice a day locally in the oral mucosa (on normal mucosa) for five days In addition to routine treatment for mouth ulcer gel adhesive will be applied and consumption of food should be two hours away, preferably at bedtime will be used.
Category
Treatment - Drugs

2

Description
After oral ulcers in the control group than in the placebo following chemotherapy plant extract is an adhesive-free gel topically on healthy mucosa of the mouth twice a day for five days taking part will be used along with routine treatments and adhesive gel food intake are two hours should be used, preferably at bedtime
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's Hospital of Tabriz
Full name of responsible person
Tahereh Alvndnzhad
Street address
Sheshgelan Ave.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Rashidi
Street address
Vice Chancellor for research، Tabriz University of Medical Sciences،university Ave. Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arshadi Bostanabad Mohammad
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty، South Shariati Street، Tabriz
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
arshadi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact

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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