FindTrial
Sign In

In patients suffering from acute or chronic Rhino-sinusitis

A Comparative, Randomized, Double Blind, Parallel Group, Placebo Controlled, Observational clinical trial study to Evaluate Efficacy and Safety of Test Product Nasal spray containing VB-Gy (Glycerol)and HPC-Cyanidins (HPC + Essential oils) versus 0.9% NaCl saline solution spray as Placebo in patients suffering from acute or chronic Rhino-sinusitis.â??

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/03/008016
Enrollment
63
Registered
2017-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- In Patients Suffering From Acute or Chronic Rhino-Sinusitis.

Interventions

Intervention1: Nasal spray containing Aqua, VB-Gy (glycerol based filmogen solution), and HPC-Cyanidins : (Hydroxypropylcellulose + Essential oils of Mantha piperita, Eucalyptus, Thymus satureioides,

Sponsors

VITROBIO
Lead Sponsor
NEXUS CLINICAL RESEARCH INDIA LTD
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients with complain of clinical manifestations of Rhino-sinusitis (RS) Major symptoms (rhinorrhea (anterior nasal discharge), postnasal drip, nasal congestion, headache, facial pain/pressure), with a minimum Rhino-sinusitis severity (RSS) score of 25 out of 50.

Exclusion criteria

Exclusion criteria: Hypersensitivity to any of the Investigational productâ??s components.

Design outcomes

Primary

MeasureTime frame
Change in mean of overall major symptoms score (sum of all symptoms of rhinorrhea (anterior nasal discharge), postnasal drip, nasal congestion, headache, facial pain/pressure scores)Timepoint: from baseline to 30 minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery—

Secondary

MeasureTime frame
Change in individual symptoms score of rhinorrhea (anterior nasal discharge), postnasal drip, nasal congestion, headache, facial pain/pressure scores) from baseline to 30 minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery (Timepoint: rom baseline to 30 minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery;Proportion of patients requiring antibiotics in Test group as compared to placebo group.Timepoint: from baseline to 30 minute post 1st dose initiation on day 1, day 2, day 3, day 6, day 15 or day of recovery—

Countries

India

Contacts

Public ContactDr Amit Bhatt

Nexus Clinical Research (India) Ltd.

mangesh.khadakban@nexuscro.com9167243914

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026