A randomized controlled trial on “the effects of shuddhi Kriyas based yoga program on allergic rhinitisâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TNSS, Anosmia, headache, fatigability and irritability
研究概览
简要总结
Allergic rhinitis is very common nowadays making it difficult for the patients to work in their full efficiency during diseased condition it reduces productivity and quality of life. Even being very prevalent in the society it is mostly underdiagnosed till it do not cause other associated problems. There are numbers of methods of alternative medicine to relieve symptoms yogic management is being one of them. Yoga is more holistic because it has components like Kriyas (cleansing techniques), Asana (physical exercise), Pranayama (breathing exercise) and meditation. We are doing this research to find out if Shuddhi Kriya Based Yoga Program is effective for Allergic Rhinitis patients when done properly on Physical, Biochemical and Psychological profile of patients. Previous intervention studies on allergic rhinitis have been using pharmacological agents and have shown high effect sizes. (> 0.7) [give reference], however, in the present study, we plan to use non-pharmacological means (yoga practices and nasal wash technique) and therefore have fixed a conservative estimate of the effect size of 0.5 and with an alpha of 0.5 and power of 0.8 the sample size in each group is calculated to be 26. And considering 20% dropout, we will recruit 30 in each group so the total sample size would be 30+30= 60 no. of Subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 41.00 Year(s)(—)
- 性别
- All
入选标准
- •Those who clinically diagnosed with Allergic rhinitis, based upon symptoms according to criteria proposed in the “International Consensus on Diagnosis and Management of Rhinitis (1994)â€: Allergic Rhinitis could be seasonal or perennial, infectious or others.
- •Those who have typical symptoms of AR including rhinorrhea, sneezing, nasal obstruction for at least 2 previous consecutive years.
排除标准
- •Nasal polyp.
- •Deviated nasal septum which is not suitable for entry of rubber catheter/Sutra.
- •Rhinitis medicaments.
- •Those who are under treatment with Systemic corticosteroid for any other disorder.
- •Patients receiving immunotherapy within the previous 2 years.
- •Subject with any history of Epistaxis.
- •CSF rhinorrhea Hypertension & heart disease, renal disease, hepatic impairments, cancer or other active medical problem.
结局指标
主要结局
TNSS, Anosmia, headache, fatigability and irritability
时间窗: 9th week, 25th week
Changes in the dosage of medication
时间窗: 9th week, 25th week
Biochemical changes- IgE, AEC,ESR
时间窗: 9th week, 25th week
Nasal swab smear test
时间窗: 9th week, 25th week
次要结局
- Quality of life Assessment tools -SQI,RQLQ,WPAI: SHP(Clinical Assessment tools-)
