Efficacy of a poly herbal mouthwash in prevention of head and neck radiotherapy-induced-oral mucositis: A double-blind randomized placebo-controlled trial

Effect of Poly herbal mouthwash in preventing mucositis

double-blind randomized placebo-controlled clinical trial with parallel groups; The sample size: 75 patients in each group 25

This study is a double blind, randomized controlled trial of 75 patients randomly divided into three 25-patient groups of controls or interventions. Eligible patients will be randomly assigned to one of the interventions by using the standard random numbers table. Group 1: poly herbal mouthwash, Group 2: Placebo mouthwash and Group III oral chlorhexidine. Each patient consumes a group of mouthwashes three times a day for 6 weeks.

Inclusion criteria: age over 18 undergoing head and neck radiotherapy Exclusion criteria: co-existing systemic diseases

Intervention group 1: polyherbal mouthwash with Aloe vera gel, Chamomile extract, honey and mint, extraction and formulation will be done in pharmacognosy and pharmaceutical labs of pharmacy faculty of Mashhad Intervention group 2: Prefabricated Chlorhexidine mouthwash ( Vi-one 0/2% CHX) (Rozhin Company) Control group: Placebo mouthwash, formulation will be done in pharmaceutical labs of pharmacy faculty of Mashhad The mouthwash will be poured into 120 cc glasses for one week consumption of the patient. The patients will rinse the mouthwash 3 times a day, 5 cc each time for 6 weeks.

mucositis based on clinical manifestations and severity of mucositis

The eligible people will be assigned in to one of the following research groups, using the standard random numbers table. At first, some part of a printed paper filled with six-digit random numbers will be selected randomly. if the selected number ends in one of the following numbers of 1, 2 or 3, this code will be assigned to intervention group 1 (Herbal mouthwash); if it ends in 4, 5 or 6, it will be assigned to intervention 2 group (Chlorhexidine mouthwash); and if the mentioned number ends in 7, 8 or 9, it will be assigned to placebo group. The number zero will not be considered here. For appropriated blinding, the selection of random allocation codes and corresponding mouthwash allocations is done by a researcher from the research team who is not directly involved in the treatment team.

This study was a prospective, double-blinded, randomized controlled clinical trial And will be performed on 75 patients who will be randomly assigned to three 25-patient groups of controls or intervention. After completing the preparation of the products, the principal investigator puts mouthwashes in the same 120-cc glasses for one week use of the patients and identifies them with a six-digit number. Patients, treatment team and investigator of clinical responses will not be aware of the types of interventions. At the end of the study, the principal investigator will decode the numbers of consumed mouthwashes and assign each to the appropriate group correctly.