Comparative clinical trial to evaluate the effect of Pippalyasava and nimbasava nasya in chronic rhinosinusitis.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Aswathi I
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Nasal Signs and Symptoms Score
Overview
Brief Summary
Chronic rhinosinusitis is an inflammatory condition affecting the paranasal sinuses that lasts
for more than 12 weeks. The clinical features include nasal discharge, nasal obstruction,
disturbance of smell and headache.
In Ayurveda, this condition can be correlated with Dushtapratishyaya based on its
symptoms. As Dushtapratishyaya is an Urdhva jatrugata vyadhi, nasya is considered as the
best treatment option. Asava is indicated for shodhana nasya in Ayurvedic classics. The effect
of Nimbasava and Shirovirechana gana dravya siddha asava nasya in this conditions has been
proven in previous studies. So, this study is planned to compare the effect of Pippalyasava and
Nimbasava nasya in chronic rhinosinusitis.
A comparative clinical trial with 38 participants satisfying the inclusion criteria will be selected
from the outpatient department of Shalakyatantra, Government Ayurveda College Hospital,
Kannur. Group A and Group B will be administered Pippalyasava and Nimbasava nasya
respectively. The effect of both the interventions will be assessed by the improvement in Nasal
Signs and Symptoms Score and Visual Analogue Scale (VAS Scale) evaluated from the
baseline, on the 6th day and follow-up on 15th day. Result will be statistically analysed
after the study.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects diagnosed with chronic rhinosinusitis within 1 month by X-rays
- •Chronicity greater than 12 weeks
- •Participants with 2 or more signs and symptoms such as nasal obstruction, mucopurulent discharge, facial pain, decreased sense of smell
- •Subjects who are willing to give written informed consent.
Exclusion Criteria
- •Subjects with clinical features of any complication of Chronic rhinosinusitis.
- •Subjects who are advised for surgical procedure.
- •Subjects with any chronic debilitating infectious diseases.
- •Subjects with nasal polyp.
- •Subjects with any evidence of nasal tumors.
- •Subjects with a history of nasal bleeding.
Outcomes
Primary Outcomes
Nasal Signs and Symptoms Score
Time Frame: 0th, 6th and 15th
VAS Scale
Time Frame: 0th, 6th and 15th
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Aswathi I
Government Ayurveda College Pariyaram Kannur