Open Labelled Passive Controlled Clinical Evaluation of External Application of Himawan Agad as Prophylaxis in Paclitaxel Chemotherapy-Induced Peripheral Neuropathy (PIPN)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Brief SummaryCancer is commonly treated with chemotherapy, but these medicines often cause side effects that reduce a patient’s comfort and quality of life. Paclitaxel, a widely used chemotherapy drug, is very effective against cancers like breast, ovarian, and lung cancer, but it frequently causes peripheral neuropathy a condition marked by tingling, burning, pain, numbness, and loss of sensation in the hands and feet. These symptoms may become severe or long-lasting, forcing doctors to reduce or stop chemotherapy. Himawan Agad, a classical Ayurvedic formulation described in Ashtanga Hridaya, is traditionally indicated for conditions involving burning, pain, inflammation, and Vata-Pitta dominance. When used externally as Himawan Agad Lepa, mixed with honey, it contains herbs known for pain relief, burn-relieving, anti-inflammatory, neuroprotective, and tissue-healing actions. This study is designed as an open-label passive-controlled clinical evaluation to assess the preventive role of Himawan Agad Lepa in patients receiving Paclitaxel chemotherapy. By applying the formulation externally, especially over vulnerable areas like the lower limbs, the therapy aims to reduce the onset and severity of neuropathic symptoms. The study seeks to establish a safe, cost-effective, and integrative Ayurvedic approach for preventing chemotherapy-induced peripheral neuropathy and improving patient comfort and treatment continuity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients having Paclitaxel as their main chemotherapy drug Patients planned for 12 weeks of paclitaxel chemo cycle Age 18 to 70 years.
排除标准
- •Patients having Diabetic Neuropathy Patients having Peripheral Neuropathy but with acute systemic adverse effects.
研究者
Dr Poorva Padmanabha Gogate
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital
