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Clinical Trials/CTRI/2024/06/068264
CTRI/2024/06/068264Not yet recruitingPhase 3

Effect of pippalyadi avapeeda nasya in chronic rhinosinusitis - a pre and post interventional study

Rekhanath K C1 site in 1 country33 target enrollmentStarted: June 12, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
33
Locations
1
Primary Endpoint
reduction in Nasal obstruction, nasal discharge, post nasal drip, headache and diminished sense of smell

Study Overview

Brief Summary

Chronic rhinosinusitis is a chronic inflammatory disease of nasal and paranasal sinus mucosa where symptomatology has continued beyond 12 weeks. Earlier the term sinusitis was used to describe

the inflammation of the mucosa of sinuses. However, as this condition is invariably associated with inflammation of the nasal mucosa, the term rhinosinusitis has been preferred. Clinical features of

chronic rhinosinusitis include nasal obstruction, nasal or postnasal purulent discharge, facial pain, disturbance of smell, headache etc.

In ayurvedic classics, signs and symptoms of chronic rhinosinusitis can be corelated to dustapratisyaya. If any pratisyaya left untreated, it may progress into dustapratisyaya and finally leads to kshaya. Therefore, prevention of this progression is necessary. Theekshna virechana nasya like Avapeeda and Pradhamana are effective in eliminating the aggravated doshas from shiras. Pippalyadi

avapeeda nasya is mentioned in Sarangadhara Samhitha, uttarakhanda, nasyavidhi adhyaya. This yoga contains pippali and saindhava. Pippali has kapha nirharatwa property and saindhava enhances the bioavailability of pippali.Chronic rhinosinusitis is a public health problem that has a significant socio-economic impact. Moreover, the complexity of this disease is due to its heterogenous nature based on underlying pathophysiology. Chronic rhinosinusitis affects 1 in 8 people in India; about 5-15% of urban population. The prevalence of rhinosinusitis has been reported to exceed that of any other chronic condition and is apparently on increase. Despite being wide spread, little is known about etiology of chronic rhinosinusitis. Contemporary management has been focused on relieving symptoms. First line of treatment is nasal saline irrigation and intranasal corticosteroid sprays. Functional endoscopic sinus surgery can be considered for patients who fail medical management. In this condition we can opt an alternate management with the formulations in ayurvedic classics. All ingredients in this formulation are easily available and cost effective. Hence this study is designed to find out the effect of Pippalyadi avapeeda nasya in the management of chronic rhinosinusitis.

Study Design

Study Type
Interventional
Allocation
Other
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subjects presenting with signs and symptoms of chronic rhinosinusitis with chronicity of 12 weeks or more.

Exclusion Criteria

  • Subjects contraindicated for nasya karma Diagnosed cases of TB, complications of sinusitis Diseases which require surgical interventions like DNS and nasal polyp.

Outcomes

Primary Outcomes

reduction in Nasal obstruction, nasal discharge, post nasal drip, headache and diminished sense of smell

Time Frame: 0th day, 6th day, 15th day,30thday

Secondary Outcomes

  • Not aplicable(Not aplicable)

Investigators

Sponsor
Rekhanath K C
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Rekhanath K C

Govt ayurveda college, Kannur

Study Sites (1)

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