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临床试验/CTRI/2024/10/075679
CTRI/2024/10/075679招募中不适用

Evaluating the Impact of Pranic Healing as a Complementary Therapy on Physical, Functional, and Emotional Outcomes in Chronic Rhinosinusitis without Nasal Polyp: A Mixed Method Study

World Pranic Healing Foundation India - Research Centre1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年11月4日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
76
试验地点
1
主要终点
Change in SNOT -22 scores and Change in Pittsburgh Sleep Quality Index scores

研究概览

简要总结

Chronic rhinosinusitis (CRS), is a common condition where the lining of the nose and sinuses gets inflamed, causing symptoms like a blocked nose, face pain, and trouble smelling, which can last for more than 12 weeks. It impacts quality of life (QOL) and sleep. This study aims to evaluate the effect of Pranic healing as a complementary therapy in CRS patients without Nasal Polyp.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Those who consent to participate in the study
  • Both male and female subjects aged 18 years to 65 years
  • Those who were diagnosed with chronic rhinosinusitis without nasal polyp with at least two of the symptoms (a) nasal blockage/obstruction/congestion, (b) nasal discharge (anterior or posterior), (c) facial pain or pressure, or (d) reduction or loss of smell.
  • Subjects with moderate to severe symptoms indicated by SNOT -22 scores ranging from 21 -100.

排除标准

  • Subjects with positive skin prick test indicating atopy Subjects with abnormal spirometry results Subjects who require surgical management within 2 months Subjects with nasal tumors, acute sinusitis, allergic fungal rhinosinusitis, allergic rhinitis Subjects with uncontrolled diabetes mellitus Subjects with severe hepatic and renal disease, and other severe medical conditions requiring immediate intervention.
  • Subjects with skin diseases such as eczema, urticaria, skin rashes Lund Mackay CT scores more than 14 Subjects who are on corticosteroids Subjects with a history of epistaxis due to secondary cause Subjects who are cognitively impaired and unable to provide reliable symptom ratings.
  • Subjects who are pregnant or lactating.
  • Subjects who are not willing to participate Subjects who are participating in any other clinical or interventional study.

结局指标

主要结局

Change in SNOT -22 scores and Change in Pittsburgh Sleep Quality Index scores

时间窗: 0, 4 Weeks

次要结局

  • Change in SNOT -22 scores(2 weeks and Telephonic follow up 6 weeks)
  • Improvement in nasal airflow and nasal patency(0, 4 Weeks)
  • Pranic Healing Experience Questionnaire (PEPQ) – Qualitative narrative(2, 4 weeks and Telephonic follow up 6 weeks)

研究者

发起方
World Pranic Healing Foundation India - Research Centre
申办方类型
Other [Trust ]
责任方
Principal Investigator
主要研究者

Roopa N

World Pranic Healing Foundation, India -Research Centre

研究点 (1)

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