Efficacy and safety of mouthwash and oral tablet of propolis on the mucositis in hematopoietic stem cell transplantation recipients

Phase 2

Recruiting

• Conditions: Condition 1: Oral mucositis. Condition 2: Gastrointestinal mucositis.; Oral mucositis (ulcerative) due to antineoplastic therapy; Gastrointestinal mucositis (ulcerative); K12.31; K92.81

• Registration Number: IRCT20100127003210N24
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

All patients hospitalized in bone marrow transplantation who received conditioning chemotherapy regimen
Patient satisfaction and cooperation to participate in the study
Ability to communicate and answering questions during the period of mucositis
Patients from previous chemotherapy or radiotherapy should not have oral mucositis and should be included in the study from the beginning of treatment

Exclusion Criteria

History of allergies to propolis or other components of mouthwash and oral tablet
History of asthma, seasonal allergies and history of aspirin allergy
Taking anticoagulant drugs such as warfarin
Fasting blood sugar above 150 mg/dl

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mucositis. Timepoint: First day of chemotherapy until engraftment day. Method of measurement: WHO scoring system.

Secondary Outcome Measures

Name	Time	Method
Fever grade. Timepoint: From the first day of chemotherapy until engraftment time. Method of measurement: Submit a fever above 38.3 °C for patients.;The need for total parenteral nutrition (TPN). Timepoint: During the study period. Method of measurement: Sign the days of parenteral nutrition intake.;The amount of narcotics analgesics needed. Timepoint: Daily. Method of measurement: Patient's medication list.;The amount of antibiotics needed. Timepoint: Daily. Method of measurement: Patient's medication list.