CTRI/2013/02/003393尚未招募3 期
A Randomized Double Blind Placebo Controlled Phase III Study of Efficacy of Lactobacillus CD2 lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantationâ??
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age between 10 and 70 years.
- •2.Karnofsky Performance Score >= 70%.
- •3.Confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is as approved modality of therapy.
- •4.Patients eligible to receive high-dose chemotherapy as part of conditioning regime.
- •5.Concomitant co morbid condition if present, controlled by medicines.
- •6.Serum creatinine ï?¼ 1.8mg/dl.
- •7.Total bilirubin ï?¼ 2mg/dl.
- •8.Liver enzymes within three times of normal limit.
- •9.Expected survival > 6 months
排除标准
- •1.Pregnant women and lactating mothers.
- •2.Patients with history of AIDS
- •3.Patients who have taken any other investigational product in last 4 weeks.
- •4.Patients having untreated symptomatic dental infection.
- •5.Patients with WHO Grade 3 or 4 oral Mucositis.
- •6.Other serious concurrent illness.
- •7.Inconclusive histological diagnosis.
- •8.Patients on anticancer antibiotics.
- •9.Patients with signs and symptoms of systemic infections.
- •10.Patientâ??s/guardianâ??s refusal to sign informed consent.
研究者
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