A Single-arm, Open Label Clinical Trial to Assess the Effectiveness of Nabhi Oil Application Over 30 Days in Adults with Agnimandya
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This is a single arm open label clinical trial designed to evaluate the effectiveness and safety of Nabhi Taila Digestion and Detox Nabhi Oil in adults diagnosed with Agnimandya The intervention consists of once daily topical application of Nabhi Oil over the umbilical region for a duration of thirty days with periodic assessments and post intervention follow up
The primary outcome measures include changes in Udgar shuddhi quality of belching and Kshudha appetite which are established Ayurvedic clinical parameters reflecting digestive function and Jatharagni status Secondary outcome measures include assessment of Agnibala associated gastrointestinal symptoms such as abdominal bloating flatulence heaviness after meals and bowel satisfaction anthropometric parameters and selected laboratory investigations
The study aims to generate clinical evidence for the therapeutic utility of Nabhi Taila as a non invasive adjunctive Ayurvedic intervention for the management of Agnimandya
Hypothesis
Null Hypothesis There is no significant improvement in digestive symptoms Udgar shuddhi and Kshudha following Nabhi Oil application in adults with Agnimandya
Alternate Hypothesis Nabhi Oil application results in a significant improvement in digestive symptoms Udgar shuddhi and Kshudha in adults with Agnimandya
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adults aged 18 to 60 years 2 Patients who have presence of digestive complaints like Udgar Ashuddh Kshudhamandya Abdominal bloating Flatulence Heaviness after meals Bowel dissatisfaction 3 Patients who are willing to provide written informed consent 4 Patients who are able to comply with study visits and assessments 5 Adults 18–60 years who during a 7-day run-in demonstrate the following based on weekly means Abdominal bloating more than 2 Flatulence score more than 2 Heaviness after meals more than 2 Bowel satisfaction less than 2.
排除标准
- •Patients who are diagnosed gastrointestinal pathology FOR EG IBD celiac disease Patients who have severe systemic illness or immunosuppression Patients who are currently using anti-inflammatory antioxidant or immunomodulatory Drugs Hemoglobin levels less than 9 Females who are pregnant or lactating mothers Patients who have known allergy to any component of the trial oils.
研究者
DR CHHAYA TANMANE
Bhausaheb mulak ayurvedic mahavidylaya nandanwan nagpur