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Clinical Trials/CTRI/2023/10/059139
CTRI/2023/10/059139Not yet recruitingPhase 1/2

A randomized controlled clinical trial to evaluate the efficacy of Anutaila Nasya and Azelastine Nasal Spray in management of Vataj Pratishyaya.

PDEAs College Of Ayurved And Research Centre1 site in 1 country56 target enrollmentStarted: October 11, 2023Last updated:
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Trial Snapshot

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
Enrollment
56
Locations
1
Primary Endpoint
Sample Size 56 Decrease in sneezing,nasal obstruction, watery rhinorrhea and headache.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The study will be intervened by the treatment of Anutaila nasya and Azelastine nasal spray to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of the symptoms. The subjective gradation of symptoms will be done as folllows and the intensity of each symptom will be calculated before treatment after treatment and after follow up. The signs and symptoms will be assessed by proper scoring method.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Not Applicable

Eligibility Criteria

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

Inclusion Criteria

  • •Patients diagnosed with Vataj Pratishyaya showing minimum three sign and syptoms like Nasastrav, Kshvathu, Nasaavrodh, Pihit nasa and Shirshool.
  • •Age from 18 to 60 will be selected irrespective of sex, socioeconomic status and religion.
  • •Patient Arah for nasya Patients ready to give written consent for trial and take part in the process of research.

Exclusion Criteria

  • •Patients with vasomotor rhinitis, acute infective rhinitis, atrophic rhinitis, rhinitis sicca, hypertrophic rhinitis.
  • •Patients having severe systemic illness Patients who require surgical interventions Patients not willing for clinical trial Patients having associated illness Bronchial Asthma.
  • •Patient Anarah for Nasya.
  • •Patients having complaints of complete or bilateral nasal obstruction.

Outcomes

Primary Outcomes

Sample Size 56 Decrease in sneezing,nasal obstruction, watery rhinorrhea and headache.

Time Frame: Sample Size 56 Decrease in sneezing,nasal obstruction, watery rhinorrhea and headache in 2 weeks.

Secondary Outcomes

  • Decrease in sneezing,nasal obstruction, watery rhinorrhea and headache.(3 months)

Investigators

Sponsor
PDEAs College Of Ayurved And Research Centre
Sponsor Class
Private medical college

Study Sites (1)

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