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临床试验/CTRI/2017/09/009900
CTRI/2017/09/009900尚未招募不适用

A randomized controlled trial on “the effects of shuddhi Kriyas based yoga program on allergic rhinitisâ€

Swami Vivekananda Yoga University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月13日最近更新:

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-)

研究者

发起方
Swami Vivekananda Yoga University
申办方类型
Research institution

研究点 (1)

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