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IRCT20260802070494N1 IRCT 2026-09-17 Tehran University of Medical Sciences Effect of honeysol and silymarin in oral mucositis Comparison of silymarin and honisol mouthwashes with standard care in preventing radiotherapy-induced oral mucositis: a randomizedclinical Trial 2026-08-23 anticipated 63 Recruiting https://irct.ir/trial/92305 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Oral mucositis in patients with head and neck radiotherapy. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: All information is suitable dor publication When: Access begina at the start of the year 1407 and remains available for six month To whom: It is exclusively for those employed at academic institution Conditions: There is no limitation Where to obtain: 09354186303 is the researcer contact .hosseinghezel82@gmail.com is the researcher email address How to obtain: Inquiries directed to the researher will be answered whith in 24 hours including responses to emails Comments:
public Hossein Ghezelsefloi
Numver 1470, North Kargar street, North Amirabad
Tehran Iran (Islamic Republic of) 1439957181 +98 911 510 6303 hosseinghezel82@gmail.com Tehran University of Medical Sciences scientific Hossein Ghezelsefloo
, Number 1470, Kouy University of Medical Sciences Dormitory،Kargar Shomali street, Amir abad shomali
تهران Iran (Islamic Republic of) ۱۴۳۹۹۵۷۱۸۱ +98 935 418 6303 hosseinghezel82@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients undergoing radiotherapy for head and neck cancer The radiotherapy regimen for patients consists of 30 sessions with a total dose of 75 Gray no limit no limit Both Patients with systemic diseases that cause oral ulceration and mucositis pregnant women; patients undergoing chemoradiotherapy. K12.30 Oral mucositis (ulcerative), unspecified Placebo Treatment - Drugs Treatment - Drugs 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 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. 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. Sevieeity of oral mucusitis. Timepoint: Before starting the study, 3 weeks later, 5 weeks later(end of the study). Method of measurement: Clinical examination. Tehran University of Medical Sciences Approved 2026-08-08 Ethics committee of Tehran University of Medical Sciences Tehran university dormitories , North Kargar ,North Amirabad Town , Tehran Tehran Iran (Islamic Republic of)