An observational study to evaluate the outcomes of Integrative multimodal Ayurveda treatment in the management of oral cancers: Prospective Cohort study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- 1 Change in QoL based EORTC scores
研究概览
简要总结
Aim-
To evaluate the outcomes of Integrative multimodal Ayurveda treatment in oral cancer management, with focus on clinical outcomes like changes in symptoms, laboratory parameters (haematological and biochemical), radiological investigations and inflammatory markers, and quality of life- in patients diagnosed with oral cancer.
Primary Objective-
To observe, document and assess the clinical outcomes (quality of life, symptom relief) in oral cancer patients undergoing Integrative multimodal Ayurveda treatment.
Secondary Objective-
-
To evaluate the safety, tolerability, and patient compliance with Ayurvedic interventions.
-
To observe and document ADR and/or AEs, if any.
-
To identify the possible conditions in Ayurveda akin to oral cancer.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Histopathologically confirmed cases of oral cancer of any type and stage with or without ongoing conventional care.
- •2 Willingness to provide written informed consent.
排除标准
- •1 Patient with other types of pathologies involving oropharyngeal organs.
- •2 Pregnant or lactating women.
结局指标
主要结局
1 Change in QoL based EORTC scores
时间窗: 1 Clinical observations recorded at every 15/30 days for 90 days | 2 QoL assessments | EORTC QLQ-H&N35, EORTC QLQ-C30, Karnofsky performance scale, FACT-GP (Version 4)
2 Change in symptom severity
时间窗: 1 Clinical observations recorded at every 15/30 days for 90 days | 2 QoL assessments | EORTC QLQ-H&N35, EORTC QLQ-C30, Karnofsky performance scale, FACT-GP (Version 4)
次要结局
- 1 Compliance rate(2 ADRs, Adverse events)
研究者
Dr Kajal Singh
All India Institute of Ayurveda