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Real-world study of Nasoclear PureHale in sino-nasal symptoms

Real-world evaluation of safety and effectiveness of 2.3% hypertonic saline soft mist spray (Nasoclear PureHaleTM) in sino-nasal symptoms

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/07/043751
Enrollment
300
Registered
2022-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J399- Disease of upper respiratory tract, unspecified

Interventions

None listed

Sponsors

Zydus Healthcare Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Data of a patient will be copied in the data collection form only if: 1. Patient had an indication for application of hypertonic saline nasal sprays, including but not limited to, e.g., viral, bacterial, or allergic rhinitis, acute or chronic rhinosinusitis 2. The patient had symptoms of nasal congestion at his/her initial visit (Visit 0) at the medical center. 3. The Total Nasal Symptom Score (TNSS) of the patient was recorded as >= 5 at visit 0. 4. The patient was eligible to receive and was prescribed Nasoclear PureHaleTM as per the physicianâ??s discretion.

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

MeasureTime frame
There is no primary outcome measure nor any formal sample size calculation. Descriptive statistics will be utilized to analyze data from the data collection form.Timepoint: Baseline and Visit 1 Visit 1 can be between day 5 to day 10 after baseline visit

Secondary

MeasureTime frame
No defined secondary outcomeTimepoint: No defined secondary outcome

Countries

India

Contacts

Public ContactDr Ashok Jaiswal

Zydus Healthcare Limited

AshokD.Jaiswal@zyduslife.com7600014339

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026