A study to see if a herbal nasal spray called Rhinagra is safe and helpful for people who have a blocked nose because of allergies or a cold

An Open-Label, Single-Arm, Multi-Centered, Phase 3 Clinical Study To Evaluate The Safety And Efficacy Of Rhinagra Herbal Nasal Spray In Subjects With Nasal Congestion Due To Allergic Rhinitis or Common Cold - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085193

Enrollment

100

Registered

2025-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: J300- Vasomotor rhinitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 60 years, of both sexes. 2. Individuals with a history and current symptoms of allergic rhinitis or the common cold, confirmed by a physician. 3. A baseline TNSS (Total Nasal Symptom Score) of 6 or more on a 0 12 scale, indicating moderate to severe nasal congestion. 4. Willingness to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Major illnesses: COPD, bronchial asthma, malignancies, cardiovascular diseases, blood disorders. 2. Nasal structure abnormalities: large nasal polyps, septal deviations, nasal ulcerations. 3. Participation in other clinical trials within the last 3 months. 4. History of psychiatric illness affecting compliance. 5. Pregnant or lactating women. 6. Any condition conflicting with the investigator s assessment.

Design outcomes

Primary

Measure	Time frame
1. The Change in Total Nasal Symptom Score (TNSS) from Baseline to Day 7. 2. The Change in Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) total score from Baseline to Day 7. 3. Time to nasal blockage relief post- administration of Rhinagra Herbal Nasal Spray.Timepoint: Day0, Day3, Day7	—

Secondary

Measure	Time frame
1. Change in Nasal Microbial Profile 2. Change in SF-36 Quality of Life Score 3. Percentage of Subjects with more than equal to 50 percentReduction in TNSS (Total Nasal Symptom Score)Timepoint: Day0, Day3, Day7	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results