A RANDOMISED OPEN LABEL DOUBLE ARM CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SNUHI KSHARA PRATISARANA KARMA IN THE MANAGEMENT OF APEENASA - CHRONIC HYPERTROPHIC RHINITIS
试验速览
- 阶段
- 2/3 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
This study is a randomized open label double arm controlled clinical trial designed to evaluate the efficacy of Snuhi Kshara Pratisarana Karma in the management of Apeenasa Chronic Hypertrophic Rhinitis in comparison with Apamarga Kshara Pratisarana which is taken as the control. Chronic hypertrophic rhinitis is a common cause of persistent nasal obstruction due to irreversible hypertrophy of the inferior turbinates, and in Ayurveda it closely correlates with Apeenasa characterized by features such as nasanaha nasa srava shirashula gurgura swasam and gandha ajnana. Classical Ayurvedic texts particularly Charaka and Sushruta Samhitas describe Kshara Pratisarana as an appropriate line of management in conditions involving adhimamsa hypertrophy especially in anatomically delicate areas like the nasal cavity.
The study includes 40 patients aged 20 to 50 years diagnosed with Apeenasa Chronic hypertrophic rhinitis who are randomly allocated into two groups of 20 each. Group A receives Apamarga Kshara Pratisarana while Group B receives Snuhi Kshara Pratisarana with 0.5 to 0.7 g of Kshara applied over the hypertrophied inferior turbinates until pakwa jambu phala varna is attained, followed by neutralization and post procedure care. The duration of the intervention is 8 days with assessments conducted before and after treatment. Outcome measures include subjective improvement in symptoms such as nasal obstruction headache abnormal respiratory sounds and olfactory disturbance as well as objective assessment of turbinate size using anterior rhinoscopy photographic documentation a modified Castroviejo caliper and the Nasal Obstruction Symptom Evaluation scale. Statistical analysis will be performed using appropriate parametric and non-parametric tests. The study aims to determine whether Snuhi Kshara Pratisarana is superior or comparable to Apamarga Kshara in reducing turbinate hypertrophy and alleviating symptoms thereby providing an effective minimally invasive Ayurvedic alternative to conventional medical and surgical management of chronic hypertrophic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Day(s) 至 50.00 Day(s)(—)
- 性别
- All
入选标准
- •Patients presenting with lakshanas of Apeenasa Chronic hypertrophic rhinitis Age 20-50 years.
排除标准
- •Malignancy Nasal Papilloma Nasal polyp Congenital anomalies of Nose and Sinus Subjects with gross Deviated Nasal Septum More than 150 Subjects with history of systemic illness that interferes the course of treatment.
研究者
Sanjai S Menon
SDM INSTITUTE OF AYURVEDA AND HOSPITAL
