A clinical study to see the effectiveness of medicated oil administration through nose on nasal flora of healthy individuals

Phase 2

Not yet recruiting

• Conditions: Subjects without any history of acute or chronic respiratory diseases

• Registration Number: CTRI/2023/07/055213
• Lead Sponsor: Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-13
• Study Start: 2023-08-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects aging between 18 to 50 years 2.
• Subjects of all gender 3.
• Subjects without any history of acute or chronic respiratory diseases 4.
• Subjects who are fit for Pratimarsha Nasya 5.
• Subjects willing to sign informed consent form.

Exclusion Criteria

• Subjects with history of nasal polyp, Deviated nasal septum, any acute or chronic respiratory illness 2.
• Subjects with chronic systematic diseases like HIV, HBsAg etc 3.
• Subjects vaccinated with Covid Vaccine in last three months 4.
• Subject having history of antibiotics intake in last three months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Urah Laghavam (Lightness in chest region)	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)	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)	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:	Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)
3.Indriyaatacchyam (clearity of sesnse organs)	Samyaka Lakshanas of Nasya will be observed everyday from baseline till 1 week (Day 1 till Day 7)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital; 🇮🇳 Hassan, KARNATAKA, India

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

🇮🇳Hassan, KARNATAKA, India

Dr Gopesh Virmani

Principal investigator

9467211800

gopesh.virmani@gmail.com