FindTrial
Sign In

To evaluate the efficacy and safety of Nigellin in individuals with allergic rhinitis

A randomized, single-blind, placebo-controlled study to evaluate the efficacy and safety of Nigellin in individuals with allergic rhinitis.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044180
Enrollment
72
Registered
2022-07-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: - Health Condition 2: -

Interventions

Intervention1: Test Arm ââ?¬â?? NigellinÃ?® AMBER 250 mg for 15 days: twice a day after food form for 15 days Control Intervention1: Placebo (control) arm ââ?¬â?? 250 mg: twice a day after food

Sponsors

Sami Sabinsa Group Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or Female in the age of 18 to 60 years. 2. At least 2 or more allergic symptoms: sneezing, rhinorrhoea, nasal obstruction, and nasal itching for a cumulative period greater than 1 hour per day. These symptoms may be accompanied by tears, itchy, swelling & red eyes. 3. Patients with a medical history of allergic rhinitis. 4. Voluntary written consent.

Exclusion criteria

Exclusion criteria: 1. Known chronic diseases such as asthma, rhinosinusitis, nasal polyposis 2. Known severe medical conditions, such as cardiovascular, liver or renal dysfunction, diabetes mellitus, cancers, cerebrovascular diseases, and blood system diseases. 3. Concomitant steroid, anticoagulant, and immunotherapy within the past 1 month. 4. Impaired haematological profile and liver / renal function. 5. Known alcohol and / or drug abuse. 6. Participants who are pregnant or lactating 7. History of serious allergic reaction to investigational product 8. Participant has participated in any clinical trial within the last 3 months 9. Any other condition which the Principal Investigator thinks may jeopardize the study.

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of Nigellin on rhinorrhoea, nasal congestion, nasal itching, and sneezing in patients with allergic rhinitis. 1.Mean change in the Total Nasal Symptom Score (TNSS) 2. Mean change in the duration of AR symptomsTimepoint: 1. Baseline to Day 15 2. Baseline to Day 15—

Secondary

MeasureTime frame
1. Mean change in the Total Ocular Symptom Score (TOSS) [Baseline to Final]. 2. Comparing active and placebo for the mean change in TNSS. 3. Comparing active and placebo for the mean change in the duration of AR symptoms. 4. Mean change in AR symptom severity. 5. Mean change in the serum levels of IgE 6. Number of times antihistamines were used during the study period as a rescue medication. 7. Mean change in Patientsââ?¬â?¢ Global Impression of Change (PGIC) Scale 8. Safety outcome by the incidence of AE.Timepoint: 1. Baseline to Final 2. Baseline to Final 3. Baseline to Final 4. Baseline to Final 5. Baseline to Final 6. Baseline to Final 7. Baseline to Final 8. Baseline to Final—

Countries

India

Contacts

Public ContactDr Alphons Philips

Sami-Sabinsa Group Limited

shaji@clinworld.net08028397973

Outcome results

None listed

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