A Randomized Controlled Comparative Clinical Trial to Evaluate the Efficacy of Lakshmivilasa Rasa and Shadbindu Taila Prathimarsa Nasya in Chronicrhinosinusitis.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Relieve in signs and symptoms of Chronic Rhinosinusitis based on subjective parameters like nasal discharge, nasal obstruction, headache and heaviness of head, loss of sense of smell, post nasal drip and objective parameters like nasal endoscopy, CT scan of PNS, palpation of sinus.
研究概览
简要总结
Chronic sinusitis is aninflammatory process that involves the paranasal sinuses and persists for 12weeks or longer. It is often presented as chronic rhinosinusitis (CRS Chronic sinusitis has similarities with sannipÄthikaprathisyÄya having kapha vÄtha doá¹£a predominance. LakshmivilÄsarasa (NÄradÄ«ya) is mentioned in Bhaiá¹£ajyaratnÄvali, rasÄyanÄdhikÄra whichis kapha vÄthara and having rasÄyana properties. Shadbindutaila, mentioned in Bhaiá¹£ajyaratnÄvali in ShirorogÄdhikÄra isVÄtha kapha samana and helps in expulsion of doá¹£as from á¹¢iras. The patients diagnosed with Chronic rhinosinusitisfulfilling inclusion and exclusion criteria will be assigned into Study groupand Control group randomly by computer generated block randomization. Eachgroup comprise 35 patients. Study group will receive LakshmivilÄsa Rasa 1tablet (250 mg) bd with honey, after food and Shadbindu taila as Prathimarsanasya 3 drops in each nostrils at 8.00am before food, for one month.Control group will be given Amoxicillin clavulanate 1 tablet (625mg) tds, afterfood for 7 days, Oxymetazoline nasal spray 2 puffs twice daily for 10 days andsteroid nasal spray (fluticasone) 2 sprays in each nostril for one month. Thestudy will be comparative, RCT. The patients will be assessed based onsubjective and objective parameters and follow up for 3 consecutive 3 monthsafter stopping the medicines, in an interval of one month. Subjectiveparameters will be assessed based on Nasal Signs and Symptoms Score (NSSS) and4 point verbal scale; just before commencing treatment, after treatment andduring follow up. Objective parameters include Nasal endoscopy, CT scan, and culturesensitivity test, assessement on before treatment and after treatment. The datacollected will be analysed statistically by using appropriate test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Chronic Rhinosinusitis
- •Patients in the age group of 18 to 60 years.
排除标准
- •chronic debilitating disease like CA, TB, AIDS.
- •Complicated sinusitis.
- •Allergic and fungal rhinosinusitis, patients with lower respiratory infection.
- •Cases which require surgical treatment.
- •Pregnant and lactating women.
- •Congenital malformation of nostrils as congenital choanal atresia, nasal glioma.
- •Patients with history of malignant hypertension and status asthmaticus.
结局指标
主要结局
Relieve in signs and symptoms of Chronic Rhinosinusitis based on subjective parameters like nasal discharge, nasal obstruction, headache and heaviness of head, loss of sense of smell, post nasal drip and objective parameters like nasal endoscopy, CT scan of PNS, palpation of sinus.
时间窗: Patients will be assessed on 30th day.
次要结局
- Recurrence of the disease(Assessment will be done for 3 consecutive months after stopping the medicines, in an interval of 1 month.)