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临床试验/CTRI/2008/091/000193
CTRI/2008/091/000193Other2 期

An invivo study to evaluate the role of curcumin in oral pre-malignant lesions and gingivo-buccal cancers

DBT0 个研究点目标入组 90 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
Other
发起方
DBT
入组人数
90

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

  • ? Age > 18 years
  • ? Histologically confirmed resectable oral cavity cancer (T3, T4a) with a co-existent premalignant condition i.e. leukoplakia or submucous fibrosis.
  • ? Gives informed consent
  • ? Previously untreated
  • ? WHO performance status of < 1
  • ? Laboratory values (performed within 14 days prior to administration of Curcumin)
  • ? WBC count > 3.0 x 109 /L
  • ? Platelet count &#8805; 150 x 109 /L
  • ? Hemoglobin &#8805; 10 gm/dl (100 gm/l)
  • ? Serum creatinine less than 1.5 times the upper normal limit
  • ? Total bilirubin less than 1.5 times the upper normal limit
  • ? SGOT or SGPT &#8804; 5.0 times upper limit of normal
  • ? Negative Pregnancy test (female patients of childbearing potential only)

排除标准

  • ? The patient is < 18 years or >75 years of age
  • ? The patient has had chemotherapy, immunotherapy, hormonal therapy, or radiation therapy within 4 weeks of the baseline visit
  • ? The patient will need concurrent chemotherapy, radiotherapy, hormonal (other than HRT for menopause), or immunotherapy during the time of study
  • ? The patient has history of any form of cancer within the past three years (excluding non-melanoma skin cancer and in situ cervical cancer)
  • ? The patient has received any investigational medication within 30 days of starting the curcumin therapy
  • ? The patient is participating in any other study

研究者

发起方
DBT

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