CTRI/2024/10/075679
Recruiting
Not Applicable
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 site in 1 country76 target enrollmentStarted: November 4, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- World Pranic Healing Foundation India - Research Centre
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Change in SNOT -22 scores and Change in Pittsburgh Sleep Quality Index scores
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in SNOT -22 scores and Change in Pittsburgh Sleep Quality Index scores
Time Frame: 0, 4 Weeks
Secondary Outcomes
- 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)
Investigators
Roopa N
World Pranic Healing Foundation, India -Research Centre
Study Sites (1)
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