Determine the efficacy and safety of Betadine Nasal Spray along with Standard care of therapy.

A Phase-3 multi centre, randomized, parallel, double blind, placebo control, clinical study to determine the efficacy and safety of Betadine Nasal spray Povidone Iodine IP 0.5% w/v for the treatment of Rhinitis in patients suffering from Rhinitis associated with Upper respiratory tract infection along with standard care of therapy. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060305

Enrollment

192

Registered

2023-11-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: J310- Chronic rhinitis

Interventions

Intervention1: Betadine Nasal spray 0.5% w/v Povidone- Iodine IP: Standard care of therapy+Betadine Nasal spray 0.5% w/v Povidone- Iodine IP Duration of Treatment- 5 days Frequency- 2-3 sprays in

Eligibility

Inclusion criteria

Inclusion criteria: Any subject who meets all of the following inclusion criteria will be eligible for the trial. 1. Ability to confirm voluntary participation and sign the informed consent form 2. Participants of both sexes, aged between 18-65 years. 3. Clinical diagnosis of acute rhinitis associated with Upper Respiratory tract infection (such as laryngitis, pharyngitis, tonsilitis and sinusitis). 4. Total nasal symptom scores greater than or equal to 6 points, with congestion and one or more of the other symptoms present (itching, runny nose, and sneezing)

Exclusion criteria

Exclusion criteria: Any subject who meets at least one of the following exclusion criteria will not be eligible for the trial. 1. History of alcohol abuse or illicit drug use; 2. Participation in a clinical trial in the year before this study; 3. Pregnancy or risk of pregnancy and lactating patients; 4. Known hypersensitivity to the formula components used during the clinical trial; 5. Participants who present other clinical forms of rhinitis, but not restricted to medicated rhinitis, vasomotor and atrophic; 6. Participant’s dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy. 7. Participants with suggestive signs of upper airways bacterial infection; 8. Participants with grade II or III septum deviation and/or presence of nasal polyps or other conditions that lead to nasal obstruction; 9. Concomitant chronic or intermittent use of decongestants, antihistamines, or corticosteroids by inhalation, oral, intramuscular, or intravenous; 10. Concomitant use of potent topical corticosteroids. 11. Sinus surgery within 30 days of beginning the study. 12. Intubated at the time of enrolment

Design outcomes

Primary

Measure	Time frame
1. To evaluate the efficacy of Betadine Nasal spray 0.5% w/ v Povidone Iodine IP in patients suffering from Rhinitis (5 Nasal symptoms) TNSS: • Sneezing, • Nasal Congestion • Rhinorrhea. • Difficult Sleeping • Nasal ItchingTimepoint: Upto Day 6	—

Secondary

Measure	Time frame
To evaluate the Safety & Tolerability of Betadine Nasal spray 0.5% w/v povidone- Iodine IP in patients suffering from Rhinitis associated with Upper Respiratory tract infection such as laryngitis, pharyngitis, tonsilitis and sinusitis. • Adverse Events assessment throughout the study period.Timepoint: Upto Day 6	—

Countries

India

Contacts

Public ContactDr Devesh Kumar

Delhi ENT Hospital & Research Centre

kacker.santosh@gmail.com9811037368

Outcome results

None listed

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