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Effect of local application of Glycyrrhiza glabra and eucalyptus extract for the prevention of chemoradiation Induced Oral Mucositis in head and neckmalignancies

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History
# Registration date Revision Id
2 2025-10-06, 1404/07/14 358048
1 2020-06-14, 1399/03/25 138953
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  • Protocol summary

    این کارآزمایی بالینی بر روی 60 بیمار که در 2 گروه 30 نفره، دارای گروه کنترل با گروههای موازی صورت می گیرد. مطالعه دو سویه کور و تصادفی شده ساده در این مطالعه صورت گرفته است.
    این کارآزمایی بالینی بر روی 60 بیمار که در 2 گروه 30 نفره، دارای گروه کنترل با گروههای موازی صورت می گیرد. مطالعه سه سویه کور و تصادفی شده ساده در این مطالعه صورت گرفته است.
    Severity of oral mucositis; The need for painkillers during the course of treatment; Need for intravenous nutrition during the course of treatment; Weight loss during the course of treatment
    Incidence of severe mucositis (Grade 3≤); need for analgesics during treatment; time of onset of mucositis; duration of mucositis
    شدت موکوزیت دهانی، نیاز به داروهای مسکن طی دوره درمان، نیاز به تغذیه وریدی طی دوره درمان، کاهش وزن بیمار طی دوره درمان
    بروز موکوزیت شدید (3≤Grade)، نیاز به داروهای مسکن طی دوره درمان، زمان شروع موکوزیت، طول مدت موکوزیت

  • General information

    Double blinded
    Triple blinded
    empty
    Given that the patient, evaluators, and statistical analyst were unaware of the group allocation, which is also mentioned in the blinding section, the present study was conducted in a triple-blind manner.
    empty
    با توجه به اینکه بیمار، ارزیاب ها و تحلیلگر آماری، اطلاعی از تخصیص گروه ها نداشتند که در قسمت کورسازی هم به آن اشاره شده مطالعه حاضر بصورت سه سو کور انجام شد

  • Primary outcomes

    #1
    Severity of oral mucositis
    Incidence of severe mucositis (Grade 3≤)
    شدت موکوزیت دهانی
    بروز موکوزیت شدید (3≤Grade)
    Clinical examination by the dentists and filling standardized physician judged mucositis grading forms
    Clinical examination by an oncologist and determination of mucositis grading using (NCI-CTCAE) version 4
    معاینه کلینیکی توسط دندانپزشک و تکمیل فرم های استاندارد درجه بندی موکوزیت از دیدگاه دندانپزشک
    معاینه کلینیکی توسط انکولوژیست و تعیین درجه بندی موکوزیت با استفاده از ( NCI-CTCAE) ورژن 4
    #2
    The need for painkillers during the course of treatment
    empty
    نیاز به داروهای مسکن طی دوره درمان
    empty
    During the course of treatment
    empty
    طی دوره درمان
    empty
    Check list
    empty
    چک لیست
    empty
    #3
    Need for intravenous nutrition during the course of treatment
    empty
    نیاز به تغذیه وریدی طی دوره درمان
    empty
    During the course of treatment
    empty
    طی دوره درمان
    empty
    Check list
    empty
    چک لیست
    empty
    #4
    Weight loss during the course of treatment
    empty
    کاهش وزن بیمار طی دوره درمان
    empty
    During the course of treatment
    empty
    طی دوره درمان
    empty
    Check list
    empty
    چک لیست
    empty

  • Secondary outcomes

    #1
    empty
    Need for painkillers during treatment
    empty
    نیاز به داروهای مسکن طی دوره درمان
    empty
    During the course of treatment
    empty
    طی دوره درمان
    empty
    Check list
    empty
    چک لیست
    #2
    empty
    The incidence of any degree of mucositis
    empty
    بروز هر درجه از موکوزیت
    empty
    During the course of treatment
    empty
    طی دوره درمان
    empty
    Examination by an oncologist and registration in the checklist
    empty
    معاینه توسط انکولوژیست و ثبت در چک لیست
    #3
    empty
    Time of onset of mucositis
    empty
    زمان شروع موکوزیت
    empty
    When mucositis begins
    empty
    زمانی که موکوزیت شروع می شود
    empty
    Examination by an oncologist and registration in the checklist
    empty
    معاینه توسط انکولوژیست و ثبت در چک لیست
    #4
    empty
    Duration of mucositis
    empty
    طول مدت موکوزیت
    empty
    Time from onset to resolution of mucositis
    empty
    زمان شروع تا بهبودی موکوزیت
    empty
    Examination by an oncologist and registration in the checklist
    empty
    معاینه توسط انکولوژیست و ثبت در چک لیست

  • Intervention groups

    #1
    Intervention group: The recipient of the solution containing Glycyrrhiza glabra and eucalyptus extract, It is recommended to use 2 cc of it in 30 cc of tepid water and gargle it three times a day for 2 to 3 minutes. Intervention until the end of the course of radiochemotherapy, the solution is prepared by a phytochemical specialist in a specialized laboratory.
    Intervention group: The recipient of the solution containing Glycyrrhiza glabra and eucalyptus extract, It is recommended to use 20 cc of it as a gargle for 30 seconds three times a day. Intervention until the end of the course of radiochemotherapy, the solution is prepared by a phytochemical specialist in a specialized laboratory.
    گروه مداخله: دریافت کننده محلول حاوی عصاره شیرین بیان و اوکالیپتوس، توصیه به استفاده از 2 سی سی از آن در 30 سی سی آب ولرم و غرغره آن سه بار در روز به مدت 2 تا 3 دقیقه، مداخله تا پایان دوره رادیو کموتراپی، محلول توسط دکترای تخصصی فیتوشیمی در آزمایشگاه تخصصی تهیه می شود.
    گروه مداخله: دریافت کننده محلول حاوی عصاره شیرین بیان و اوکالیپتوس، توصیه به استفاده از 20 سی سی از آن بصورت غرغره کردن ظرف 30 ثانیه سه بار در روز ، مداخله تا پایان دوره رادیو کموتراپی، محلول توسط دکترای تخصصی فیتوشیمی در آزمایشگاه تخصصی تهیه می شود.
    #2
    Control group: The recipient of the container containing the normal saline solution, It is recommended to use 2 cc of it in 30 cc of tepid water and gargle it three times a day for 2 to 3 minutes. Intervention until the end of the course of radiochemotherapy, the solution is prepared by a phytochemical specialist in a specialized laboratory.
    Control group: The recipient of the container containing the normal saline solution, It is recommended to use 20 cc as a gargle for 30 seconds. Intervention until the end of the course of radiochemotherapy, the solution is prepared by a phytochemical specialist in a specialized laboratory.
    گروه کنترل: دریافت کننده ظرف حاوی محلول نرمال سالین، توصیه به استفاده از 2 سی سی از آن در 30 سی سی آب ولرم و غرغره آن سه بار در روز به مدت 2 تا 3 دقیقه، مداخله تا پایان دوره درمان رادیوکموتراپی، محلول توسط دکترای تخصصی فیتوشیمی در آزمایشگاه تخصصی تهیه می شود.
    گروه کنترل: دریافت کننده ظرف حاوی محلول نرمال سالین، توصیه به استفاده از 20 سی سی بصورت غرغره کردن به مدت 30 ثانیه، مداخله تا پایان دوره درمان رادیوکموتراپی، محلول توسط دکترای تخصصی فیتوشیمی در آزمایشگاه تخصصی تهیه می شود.

Protocol summary

Study aim
Effect of local application of Glycyrrhiza glabra and eucalyptus extract for the prevention of chemoradiation Induced Oral Mucositis in head and neck malignancies
Design
This clinical trial was performed on 60 patients, divided into two groups of 30, including a control group and parallel groups. This study is blinded and simple randomization is used.
Settings and conduct
The field of work is clinical - internal. This study is performed in the Tohid Hospital in Sanandaj. The intervention group is given the solution containing Glycyrrhiza glabra and eucalyptus extract until the end of the course of radiotherapy. The control group is given the container containing the normal saline solution until the end of the course of radiotherapy,
Participants/Inclusion and exclusion criteria
Inclusion criteria:Head and neck carcinoma; Full awareness; Oral mucosal health Exclusion criteria: History of allergy to medicinal plants; High blood pressure; Diabetes; Autoimmune diseases; Cardiovascular disease; The presence of mucosal lesions in the mouth; Previous history of radiotherapy and chemotherapy; Chronic liver diseases; Non-use of drugs; alcohol; cigarettes
Intervention groups
Intervention group: The recipient of the solution containing Glycyrrhiza glabra and eucalyptus extract, Intervention until the end of the course of radiotherapy. Control group: The recipient of the container containing the normal saline solution, Intervention until the end of the course of radiotherapy
Main outcome variables
Incidence of severe mucositis (Grade 3≤); need for analgesics during treatment; time of onset of mucositis; duration of mucositis

General information

Reason for update
Given that the patient, evaluators, and statistical analyst were unaware of the group allocation, which is also mentioned in the blinding section, the present study was conducted in a triple-blind manner.
Acronym
IRCT registration information
IRCT registration number: IRCT20190415043279N4
Registration date: 2020-06-14, 1399/03/25
Registration timing: registered_while_recruiting

Last update: 2025-10-06, 1404/07/14
Update count: 1
Registration date
2020-06-14, 1399/03/25
Registrant information
Name
Pezhman Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 9435
Email address
p.sharifi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local application of Glycyrrhiza glabra and eucalyptus extract for the prevention of chemoradiation Induced Oral Mucositis in head and neckmalignancies
Public title
Effect of local application of Glycyrrhiza glabra and eucalyptus extract for the prevention of Mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Head and neck carcinoma Full awareness Oral mucosal health
Exclusion criteria:
History of allergy to medicinal plants High blood pressure Diabetes Autoimmune diseases Cardiovascular disease Neutropenia The presence of mucosal lesions in the mouth Previous history of radiotherapy and chemotherapy Chronic liver diseases Active collagen vascular disease Non-use of drugs; alcohol; cigarettes
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, according to a randomized list, is assigned by a person outside the study according to the corresponding codes in the sealed envelopes, then assigned to any disease that is included in the study. Medications are identical in appearance, packaging, color, and so on.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Container solutions and placebo were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.MUK.REC.1396/75

Health conditions studied

1

Description of health condition studied
Oral Mucositis
ICD-10 code
K12
ICD-10 code description
Stomatitis and related lesions

Primary outcomes

1

Description
Incidence of severe mucositis (Grade 3≤)
Timepoint
The beginning of the intervention, every week continuously, the end of the intervention, one week after the end of the intervention
Method of measurement
Clinical examination by an oncologist and determination of mucositis grading using (NCI-CTCAE) version 4

Secondary outcomes

1

Description
Need for painkillers during treatment
Timepoint
During the course of treatment
Method of measurement
Check list

2

Description
The incidence of any degree of mucositis
Timepoint
During the course of treatment
Method of measurement
Examination by an oncologist and registration in the checklist

3

Description
Time of onset of mucositis
Timepoint
When mucositis begins
Method of measurement
Examination by an oncologist and registration in the checklist

4

Description
Duration of mucositis
Timepoint
Time from onset to resolution of mucositis
Method of measurement
Examination by an oncologist and registration in the checklist

Intervention groups

1

Description
Intervention group: The recipient of the solution containing Glycyrrhiza glabra and eucalyptus extract, It is recommended to use 20 cc of it as a gargle for 30 seconds three times a day. Intervention until the end of the course of radiochemotherapy, the solution is prepared by a phytochemical specialist in a specialized laboratory.
Category
Prevention

2

Description
Control group: The recipient of the container containing the normal saline solution, It is recommended to use 20 cc as a gargle for 30 seconds. Intervention until the end of the course of radiochemotherapy, the solution is prepared by a phytochemical specialist in a specialized laboratory.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Bayazid Ghaderi
Street address
Tohid Hospital, Geriashan Ave
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3366 4645
Email
bayazid.g@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Bayazid Ghaderi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Blood and oncology
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
bayazid.g@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Bayazid Ghaderi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Blood and oncology
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
bayazid.g@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
bayazid Ghaderi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Blood and oncology
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
bayazid.g@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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