Efficacy of Nasal spray made of selected drugs of Aṇutaila against Nasya of Aṇutaila in Chronic sinusitis – A Randomised Controlled Noninferiority Trial
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Vaidyaratnam PS Variers Ayurveda College Kottakkal
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- 1 Scale for scoring symptoms of Chronic sinusitis
Overview
Brief Summary
A randomised controlled non inferiority trial is planned in chronic sinusitis to compare anuthaila nasya and nasal spray made of selected drugs of anuthaila. Chronic sinusitis is a kapha pradhana vyadhi that shows seasonal flare ups and requires frequent sodhana. Nasya with anuthaila is having notewothy excretory action but patient complaince is low. Nasal spray is prepared as a combination of distillate and kasaya of selected drugs of anuthaila. The safety is assesed by event evaluation scale and anterior rhinoscopy. An assessment of efficacy will be done using the Scale for scoring of symptoms of Chronic sinusitis, Rhinosinusitis Disability Index (RDI) and Visual Analogue scale (VAS) for pain.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Participants fulfilling diagnostic criteria 2 Participants indicated for nasya 3 Participants of all gender in between age 18 and 60 years 4 Those who have willingness to participate in the study.
Exclusion Criteria
- •1 Blood-stained nasal discharge 2 Nasal polyp 3 H/o polypectomy and sinus surgery within 3 months 4 Uncontrolled Diabetes Mellitus and Hypertension 5 Pregnant/ lactating women 6 History of hypersensitivity to the trial drug 7 Any other condition that may jeopardize the study.
Outcomes
Primary Outcomes
1 Scale for scoring symptoms of Chronic sinusitis
Time Frame: 0,7,14 and 30th day
2 Rhinosinusitis Disability Index15
Time Frame: 0,7,14 and 30th day
3 Visual Analogue Scale for pain
Time Frame: 0,7,14 and 30th day
4 Samyak nasya lakshana assessment proforma
Time Frame: 0,7,14 and 30th day
5 Event Evaluation Scale
Time Frame: 0,7,14 and 30th day
Secondary Outcomes
- HPTLC GC Of nasal spray of selected drugs of anuthaila(6 months)