Randomized open labelled clinical study to evaluate the efficacy, tolerability and safety of Dhoomapana therapy in patients of Head and Neck cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Health related quality of life as assessed by FACT-G
研究概览
简要总结
Head and Neck cancers pose a great challenge for physicians as well as patients. Dhoomapana is a therapy mentioned in Ayurveda for various oral as well as Head and Neck related disorders .In this therapy fume of various herbometallic formulations are delivered directly over the lesions.
This is a prospective open labelled study to evaluate safety, efficacy and tolerability of patients undergoing Dhoompana therapy by using a self designed questionnaire called Dhoomapana Efficacy and safety assessment questionnaire.(DESA). We will plan to design two groups. In group A Subjects will receive Rasayana therapy (AMRUT) for their disease and in Group B – Subjects will receive Rasayana therapy (AMRUT) along with Dhoomapana according to eligibility criteria. The benefits of this research will be to understand how non pharmacological interventions such as Dhoompana therapy can help manage Head and Neck cancer related symptoms and tumor regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Male and Female cancer patients suffering from head and neck cancers.
- •2.Cancer patients refractory to conventional line of treatment.
- •Cancer patients willing to take ayurvedic treatment for management of cancer.
排除标准
- •Patients taking conventional anticancer therapies.
结局指标
主要结局
Health related quality of life as assessed by FACT-G
时间窗: Day0,Day15, Day30,Day60,Day90.
次要结局
- Adverse events monitoring.(Baseline (Day0), Day30, Day60, Day90.)
- Tumor response as assessed radiologically.(Baseline (Day0), Day90)
