Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-30 @ 2:35 PM
Study NCT ID:
NCT05250661
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2022-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Propolis in the Prevention of Oral Mucositis
Sponsor:
Karadeniz Technical University
Organization:
Study Overview
Official Title:
Determination of the Effectiveness of Propolis in the Prevention of Oral Mucositis in Patients Receiving High Dose Chemotherapy: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OM
Brief Summary:
The study was carried out to determine the efficacy of propolis in the prevention of oral mucositis and gastrointestinal symptoms associated with oral mucositis in patients with leukemia, lymphoma, and myelodysplastic syndrome receiving high-dose chemotherapy and/or hematopoietic stem cell transplantation. 64 patients, 32 in the propolis and 32 in the control group, were involved in the prospective randomized controlled experimental study. While the standard oral care treatment protocol of the clinic was administered to the control group, aqueous propolis extract was applied to the propolis group in addition to the standard oral care treatment protocol.
Detailed Description:
Objective: The study was carried out to determine the efficacy of propolis in the prevention of oral mucositis and gastrointestinal symptoms associated with oral mucositis in patients with leukemia, lymphoma, and myelodysplastic syndrome receiving high-dose chemotherapy and/or hematopoietic stem cell transplantation.
Study Design:
The study was conducted as a randomized controlled experimental study. Approval from the Ethics Committee and written permission from the Institution were obtained. After the participants were informed about the purpose of the study, their written consents were obtained. 64 patients, 32 in the propolis and 32 in the control group were involved in the study that was performed in the Hematology and Bone Marrow Transplantation Unit.
The control group patients used the standard oral care treatment protocol (Tanflex (3x1) and NaHCO3 (1x1)) of the clinic , while the propolis group used the aqueous extract of propolis in addition to this protocol. The individuals in the propolis group gargled 4 times a day (after meals and before going to bed at night) with 5 ml aqueous propolis extract. All patients underwent a daily intraoral examination up to 21 days from the start of high dose chemotherapy. Oral mucositis was recorded on the WHO oral toxicity scale and other gastrointestinal symptoms were recorded on the National Cancer Institute-Common Terminology Criteria for Adverse Events scale
Study Design:
The study was conducted as a randomized controlled experimental study. Approval from the Ethics Committee and written permission from the Institution were obtained. After the participants were informed about the purpose of the study, their written consents were obtained. 64 patients, 32 in the propolis and 32 in the control group were involved in the study that was performed in the Hematology and Bone Marrow Transplantation Unit.
The control group patients used the standard oral care treatment protocol (Tanflex (3x1) and NaHCO3 (1x1)) of the clinic , while the propolis group used the aqueous extract of propolis in addition to this protocol. The individuals in the propolis group gargled 4 times a day (after meals and before going to bed at night) with 5 ml aqueous propolis extract. All patients underwent a daily intraoral examination up to 21 days from the start of high dose chemotherapy. Oral mucositis was recorded on the WHO oral toxicity scale and other gastrointestinal symptoms were recorded on the National Cancer Institute-Common Terminology Criteria for Adverse Events scale
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: