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Clinical Trials/CTRI/2023/07/055213
CTRI/2023/07/055213Not yet recruitingPhase 2

A Clinical Study To Evaluate the Effectiveness of Pratimarsha Nasya with Anu Taila on Nasal Flora of Healthy Individuals

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital1 site in 1 country30 target enrollmentStarted: August 15, 2023Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
1.Urah Laghavam (Lightness in chest region)

Study Overview

Brief Summary

This study is an open label, single arm, prospective, clinical study to evaluate the effectiveness of Pratimarsha Nasya with Anu Taila on Nasal Flora of Healthy Individuals that will be conducted in India. The primary outcome measures will be samyaka lakshanas of Nasya that will be assessed before treatment and everyday of Nasya for 7 days and after Nasya on 8th day. Respiratory health of subjects will be analyzed using MRC Breathlessness Scale. The secondary outcome measures will be the collected swab samples to analyze number and variety of microorganisms present in the nasal flora and this will be assessed before and after treatment

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subjects aging between 18 to 50 years
  • Subjects of all gender
  • Subjects without any history of acute or chronic respiratory diseases
  • Subjects who are fit for Pratimarsha Nasya
  • Subjects willing to sign informed consent form.

Exclusion Criteria

  • Subjects with history of nasal polyp, Deviated nasal septum, any acute or chronic respiratory illness
  • Subjects with chronic systematic diseases like HIV, HBsAg etc
  • Subjects vaccinated with Covid Vaccine in last three months
  • Subject having history of antibiotics intake in last three months.

Outcomes

Primary Outcomes

1.Urah Laghavam (Lightness in chest region)

Time Frame: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)

2.Shiro Laghavam (lightness in head region)

Time Frame: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)

4.Sroto Vishudhi (clearance of bodily channels)

Time Frame: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)

Time taken to achieve Samyaka Lakshanas of Nasya will be observed:

Time Frame: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)

3.Indriyaatacchyam (clearity of sesnse organs)

Time Frame: Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)

Secondary Outcomes

  • Respiratory health of subjects will be analyzed using MRC Breathlessnes Scale(The collected swab samples will be analyzed for the number and variety of microorganisms present in the nasal flora)

Investigators

Sponsor
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Sponsor Class
Private medical college

Study Sites (1)

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