CTRI/2023/01/048769进行中（未招募）3 期
"Efficacy of Traditional Ayurvedic Formulation (Divya Cystogrit) in Cysts, Fibroids and Benign tumor patients: a single arm, open-label, prospective, observational study"
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To observe the changes in quality of life in cancer patients taking Divya Cystogrit as per the treatment protocol by an ayurvedic practitioner.
研究概览
简要总结
This study is an Open-label, prospective observational study in order to verify the safety and efficacy of the formulation of Divya Cystogrit Tablet in patients suffering from Cysts, benign tumors, and fibroids.
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
- •The age of the subject will be 18-70 years.
- •Subjects with a malignant tumor confirmed by histopathology or cytology.
- •Willing to participate and give consent for the study.
- •Capability for complete compliance and completion of follow-up.
排除标准
- •Known allergy to any of the active ingredients or excipients of the study drug, or have a history of allergy to other opioids or NSAIDs and their related ingredients...
- •The subject with a known history of gastrointestinal bleeding or perforation, a positive result of fecal occult blood test during screening period, serious cardiovascular diseases, a history of an acute ischemic or hemorrhagic stroke within 6 months prior to screening, a history of significant psychiatric disorders, such as schizophrenia and depression.
- •History of alcohol abuse or drug abuse including opioids have significant opioid contraindications.
- •Expected pregnancy or breastfeeding.
- •The subject who is not willing to provide consent and comply with the protocol.
结局指标
主要结局
To observe the changes in quality of life in cancer patients taking Divya Cystogrit as per the treatment protocol by an ayurvedic practitioner.
时间窗: Baseline, Day 30, Day 60
次要结局
- Changes in the Numeric Pain Rating Scale (NPRS), EORTC QOL C-30, Depression-Anxiety Stress Scale (DASS-21) and Medication Adherence Report Scale (MARS).
研究者
研究点 (2)
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