Effectiveness of Turmeric Mouthwash in Preventing and Reducing the Severity of Conditioning-Induced Oral Mucositis in Bone Marrow Transplant Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the effect of turmeric mouthwash on the incidence and grade of
研究概览
简要总结
Oral mucositis is a common and painful complication of bone marrow transplantation leading to difficulty in eating, risk of infection, prolonged hospitalization and higher treatment costs. Current preventive and management strategies, including basic oral care and
pharmacological interventions, are often insufficient, costly, or not widely available. Curcumin, the active compound in turmeric, has shown anti-inflammatory, antioxidant, and antimicrobial effects, reducing the incidence, severity, and pain of oral mucositis in chemotherapy and radiotherapy patients. However, evidence in bone marrow transplant recipients is limited, and standardized protocols are lacking. Investigating Turmeric
mouthwash as an adjunct to usual care could provide a safe, cost-effective, and culturally acceptable option to prevent or reduce oral mucositis in this high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged equal to more than 6 years (children and adults) scheduled for autologous or allogeneic stem cell transplantation.
- •Patients scheduled for myeloablative or reduced-intensity conditioning chemotherapy.
- •For adults (more than 18 years Ability to provide written informed consent.
- •For children (less than 18 years): Written informed consent from parent/guardian and assent from the child (age-appropriate).
- •Capability to perform oral rinses independently or with caregiver assistance.
排除标准
- •Known hypersensitivity to turmeric or curcumin.
- •Presence of severe pre-existing oral lesions unrelated to chemotherapy (except mild gingivitis).
结局指标
主要结局
To assess the effect of turmeric mouthwash on the incidence and grade of
时间窗: baseline and 1odays after intervention
conditioning-induced oral mucositis in patients undergoing bone marrow
时间窗: baseline and 1odays after intervention
transplantation.
时间窗: baseline and 1odays after intervention
次要结局
- To compare the incidence of oral mucositis between patients receiving turmeric(mouthwash with usual care and those receiving usual care alone.)
研究者
Nisha Kumari khowal
AIIMS DELHI