Randomized controlled clinical evaluation of Pippalyadi Avapida Nasya followed by Anutaila Pratimarsha Nasya in Pratishyaya with special reference to Chronic Rhinosinusitis.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- 1. Classical parameters of Pratishyaya
研究概览
简要总结
Present study is a randomized, two parallel arm interventional comparative clinical trial of 30 days duration. In this study the effectiveness of Pippalyadi avapida nasya followed by Anutaila pratimarsha nasya will be compared to hypertonic saline solution (3.5 % NaCl) nasal drop in Pratishyaya. Evaluation assessments will be done at base line (0-day), 15th day and 30th day (completion).
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 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient who are willing to participate in the study and ready to give a written informed consent.
- •Subjects of either sex in the age group of 18 to 60 years.
- •Patients who are having the clinical signs and symptoms of Pratishyaya.
- •Patients fulfilling the criteria of chronic rhinosinusitis as per American Academy of Otolaryngology—Head and Neck Surgery (2015).
排除标准
- •Patient with migraine, tension type of headache, cluster headache, glaucoma or any other type of headache, except sinusitis.
- •Patients with space occupying lesion of brain.
- •Patients with nasal polyp, deviated nasal septum or any benign or malignant growth of nose and paranasal sinuses.
- •Known patient of epilepsy, mental disorder, malignancy, serious acute organic disease, or any serious comorbidity that will make it impossible to participate in the trial interventions.
- •Pregnant or lactating women.
结局指标
主要结局
1. Classical parameters of Pratishyaya
时间窗: Base line | 15th day | 30th day
2. Sino-Nasal Outcome Test - 22 (SNOT-22) questionnaire score
时间窗: Base line | 15th day | 30th day
3. Sino-Nasal Outcome Test - 20 (SNOT-20) questionnaire score
时间窗: Base line | 15th day | 30th day
4. Sinus Control Test (SCT)
时间窗: Base line | 15th day | 30th day
5. Haziness over the PNS (Maxillary sinuses) in X-Ray PNS water’s view
时间窗: Base line | 15th day | 30th day
6. Haziness over the frontal sinuses in X-Ray Skull Caldwell view
时间窗: Base line | 15th day | 30th day
7. Erythrocyte Sedimentation Rate (ESR)
时间窗: Base line | 15th day | 30th day
8. C-Reactive Protein (CRP)
时间窗: Base line | 15th day | 30th day
次要结局
- Adverse effect of the treatment(after treatment)
研究者
Ashutosh Kumar Maurya
North Eastern Institute of Ayurveda and Homoeopathy
