Comparison of the incidence of oral mucositis among the three study groups. Comparison of the severity of oral mucositis among the three study groups.
Design
The study is designed as a Phase II, randomized, double-blind, controlled trial with a parallel-group design involving 63 participants (21 participants per group).
Randomization and Allocation:To ensure equal distribution among the three arms, balanced block randomization with a block size of three will be employed. The randomization sequence will be produced via Random Allocation Software.
Settings and conduct
TheConducted at Sadaf Clinic (Imam Khomeini Hospital Complex), this study employs a blinded design. Randomization and allocation will be managed by a non-clinical third party to prevent bias. Clinicians and assessors will be blinded to treatments, which are visually identical. Participants will rinse thrice daily for one minute (expectorating thereafter). Assessments start one week post-radiotherapy, with follow-ups lasting one to two months. All adverse effects will be monitored across all groups
Participants/Inclusion and exclusion criteria
:Patients undergoing head and neck radiotherapy due to cancer. The radiotherapy regimen consists of 30 sessions with a total dose of 75 Gy. Exclusion Criteria:Patients with systemic diseases causing oral ulceration or mucositis. Pregnant women. Patients undergoing concurrent chemoradiotherapy.
Intervention groups
The particieThe three study arms consist of: (1) Control: standard care (normal saline, Nystatin, and dietary advice); (2) Silymarin: a prepared mouthwash using Gol Daru tablets dissolved in water; and (3) Hanisol: Hanisol syrup (Manitasa) used as a mouthwash. All interventions require a one-minute rinse three times daily, followed by expectoration
Main outcome variables
The incidence and severity of oral mucositis will be compared among the three study groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260802070494N1
Registration date:2026-09-17, 1405/06/26
Registration timing:registered_while_recruiting
Last update:2026-09-17, 1405/06/26
Update count:0
Registration date
2026-09-17, 1405/06/26
Registrant information
Name
Hossein Ghezelsefloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 418 6303
Email address
hosseinghezel82@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2026-12-22, 1405/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of silymarin and honisol mouthwashes with standard care in preventing radiotherapy-induced oral mucositis: a randomizedclinical Trial
Public title
Effect of honeysol and silymarin in oral mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing radiotherapy for head and neck cancer
The radiotherapy regimen for patients consists of 30 sessions with a total dose of 75 Gray
Exclusion criteria:
Patients with systemic diseases that cause oral ulceration and mucositis
pregnant women;
patients undergoing chemoradiotherapy.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated into the three study groups using a block-balanced randomization method with random blocks of three. The randomization sequence will be generated using block randomization software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The randomization sequence and allocation envelopes were prepared and maintained by a person outside the clinical evaluation team to reduce the risk of allocation bias. The study drugs were identical in appearance. The treatment team and the evaluators of mucositis severity were blinded to the randomization sequence.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran university dormitories , North Kargar ,North Amirabad Town ,
City
Tehran
Province
Tehran
Postal code
1439957181
Approval date
2026-08-08, 1405/05/17
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1405.024
Health conditions studied
1
Description of health condition studied
Oral mucositis in patients with head and neck radiotherapy
ICD-10 code
K12.30
ICD-10 code description
Oral mucositis (ulcerative), unspecified
Primary outcomes
1
Description
Sevieeity of oral mucusitis
Timepoint
Before starting the study, 3 weeks later, 5 weeks later(end of the study)
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients used 5 cc of 0.9% normal saline as a mouthwash three times a day for 5 weeks, and then spit it out.The solution is stored in dark containers
Category
Placebo
2
Description
Intervention group: To prepare the silymarin mouthwash, 140 mg silymarin tablets (produced by Goldaru Pharmaceutical Company) will be used. Each tablet will be dissolved in 100 ml of sterile normal saline to obtain a uniform solution. To ensure complete dissolution, the tablet will first be crushed and then dissolved under gentle agitation. The prepared solution must be fresh and will be prepared on a daily basis. The final concentration of silymarin will be 140 mg/100 ml (1.4 mg/ml). After preparation, the solution will be stored in a dark, sealed container. Patients will be instructed to hold 10 ml of the solution in their mouth, gargle for 1 minute, and then expectorate it, three times a day. The recommended duration of 1 minute for using the silymarin mouthwash is based on standard protocols in pharmacological studies. This duration allows sufficient time for effective contact between the active ingredient and the oral mucosa to achieve maximum therapeutic effect. Previous studies on therapeutic mouthwashes have also frequently recommended 30-to-60-second intervals for optimal efficacy.
Category
Treatment - Drugs
3
Description
Intervention group: The Honey-Sol syrup, containing 20% honey and 5% turnip extract in a 120 ml volume, will be used as a mouthwash. The syrup will be mixed with sterile distilled water at a 1:2 (v/v) ratio. The solution will be stored in light-resistant (dark) containers. Patients will rinse their mouths with 10 ml of the solution three times daily and then expectorate it.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini (RA) Hospital, Sadaf Clinic
Full name of responsible person
Dr.soheila mahanifar
Street address
Imam Khomeini (RA) Hospital, end of Keshavarz Blvd, North Kargar St.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 912 620 3396
Email
soheilamanifar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.seddigheh hashemi kamangar
Street address
Faculty of Dentistry, Tehran University of Medical Sciences, North Amirabad, North Kargar St.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4000
Email
dentistry@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossein Ghezelsefloi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Numver 1470, North Kargar street, North Amirabad
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 911 510 6303
Email
hosseinghezel82@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Ghezelsefloo
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
, Number 1470, Kouy University of Medical Sciences Dormitory،Kargar Shomali street, Amir abad shomali
City
تهران
Province
Tehran
Postal code
۱۴۳۹۹۵۷۱۸۱
Phone
+98 935 418 6303
Email
hosseinghezel82@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Ghezelsefloi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Number 1470, Kouy University of Medical Sciences Dormitory،Kargar Shomali street, Amir abad shomali
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۷۱۸۱
Phone
+98 935 418 6303
Email
hosseinghezel82@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information is suitable dor publication
When the data will become available and for how long
Access begina at the start of the year 1407 and remains available for six month
To whom data/document is available
It is exclusively for those employed at academic institution
Under which criteria data/document could be used
There is no limitation
From where data/document is obtainable
09354186303 is the researcer contact .hosseinghezel82@gmail.com is the researcher email address
What processes are involved for a request to access data/document
Inquiries directed to the researher will be answered whith in 24 hours including responses to emails