Study of intranasal oil instillation (Pratimarsha Nasya)for protective effect in healthy individuals
Phase 2
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Apparently healthy adults [as determined by clinical history, general physical examination, Hematological and biochemical parameters (CBC, LFT, RFT)],
2. Aged from 18 to 40 years age of any sex
Exclusion Criteria
b.Exclusion Criteria:
i.Nasal conditions: Septal deviations, hypertrophied turbinates, intra nasal masses, symptoms as nasal bleeding, chronic rhinitis
ii.Psychiatric or other conditions that in the opinion of the investigator may hamper study participation
iii.Known cases of uncontrolled diabetes mellitus, uncontrolled hypertension
iv.Pregnant or lactating women
v.Regularly practicing Jalneti, Pranayam, or any other intranasal treatment since one month from the day of screening
vi.On oral or intranasal steroid therapy since last 4 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in expression of mucins viz., MUC5AC and MUC5B after intranasal oil instillationTimepoint: Baseline , Week 4, week 8, week 12, week 16
- Secondary Outcome Measures
Name Time Method 1) Change in pH of nasal mucosa <br/ ><br>2) Change in levels of cytokines viz., IL6, IL10, TNF α, IFN λ and Secretary Immunoglobin (sIgA) in nasal mucus <br/ ><br>3) Change in mRNA expression of the tight junction proteins viz., Occludin, Claudins and JAM in nasal mucus. <br/ ><br>4) Change in microbial diversity in the nasal mucosa <br/ ><br>5) Incidence and severity of upper respiratory symptoms <br/ ><br>6) Change in quality of sleep <br/ ><br>7) Change in level of mental stress <br/ ><br>8) ADRs and AEs <br/ ><br>Timepoint: Baseline, Weeks 4, 8, 12 and 16