IRCT201203012464N4 IRCT 2016-07-01 Mrs zolfaghari The effect of aqueous extract of Glycyrrhiza glabra on oral inflammation from radiotherapy . The Effect of Glycyrrhiza glabra extract on oral mucositis of patients under head and neck radiotherapy. 2013-01-20 anticipated 36 Complete https://irct.ir/trial/2184 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: head and neck malignancecies. Condition 2: Mucositis. Intervention 1: The bottles containing 100 cc aqueous Glycyrrhiza extract 50% was given to every patient and ask them to use 2 cc twice per day for 14 days after starting radiotherapy. Intervention 2: The bottles containing 100 cc liquid as placebo was given to every patient and ask them to use 2 cc twice per day for 14 days after starting radiotherapy.

public Dr Shamsolmolok Najafi

Faculty of Dentistry,University of Medical Sciense, Kuy-e-Daneshgah, Ghods St, Enghelab Blvd, Tehran, Iran

Tehran Iran (Islamic Republic of) +98 21 4423 7730 najafi_sh@tums.ac.ir Tehtan University of Medical Siense scientific samira hajheidary

Faculty od Dentistry, Tehran University of Medical Sciences The end of Amirabad st., Enghelab sq.

Tehran Iran (Islamic Republic of) +98 21 4423 7730 S.hajheidary@gmailc.om Tehran University of Medical Sciens Iran (Islamic Republic of) Inclusion criteria: Patients should be at least 18 years old; There should be definite diagnosis of head and neck cancer for patients; Radiation therapy dose determined by patient’s radiotherapist should be at least 50 Gy (the average dose that often cause mucositis); Patient should have the ability of using extract before every radiotherapy session; At least 50% mouth cavity should be in ray field (diagnosed by radiotherapy expert). Exclusion criteria: Patients who are now under radiotherapy for head and neck cancer and or have received every type of treatment and ray therapy for head and neck cancer in recent year. Patients with allergic history to glycyrrhiza. Patients who may show complications to medicine. Patients who couldn’t use aqueous glycyrrhiza extract in their mouth on the base of their verdict or their examiner’s saying.Patients who had every type of mouth problem for example active infection, wound and etc. Before starting radiotherapy. Patient’s announcement of not cooperating in every step of project. 18 years 149 years Both C00-C14 L55-L59 Malignant neoplasms of lip, oral cavity and pharynx Radiation-related disorders of the skin and subcutaneous tissue Treatment - Drugs Placebo The bottles containing 100 cc aqueous Glycyrrhiza extract 50% was given to every patient and ask them to use 2 cc twice per day for 14 days after starting radiotherapy. The bottles containing 100 cc liquid as placebo was given to every patient and ask them to use 2 cc twice per day for 14 days after starting radiotherapy. Burning mouth. Timepoint: The first day and at the end of 14. Method of measurement: visual scale. Wound size. Timepoint: The first day and at the end of 14. Method of measurement: Scaled graph paper. Drug interactions with analgesic drugs of patients. Timepoint: 1week. Method of measurement: visual scale. Licorice sensitivity. Timepoint: 14 days. Method of measurement: Observability and Question. Mrs zolfaghari Approved 2013-10-22 Tehran University of Medical Sciences Faculty of Dentistry, University of Medical Sciences, Kuy-e-Daneshgah, Ghods St, Enghelab Blvd, Tehran, Iran Tehran Iran (Islamic Republic of)