To evaluate the efficacy andsafety of Nigellin in individuals with allergic rhinitis
- Conditions
- Health Condition 1: - Health Condition 2: -
- Registration Number
- CTRI/2022/07/044180
- Lead Sponsor
- Sami Sabinsa Group Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of Nigellin on rhinorrhoea, nasal congestion, nasal itching, and sneezing in patients with allergic rhinitis. <br/ ><br>1.Mean change in the Total Nasal Symptom Score (TNSS) <br/ ><br>2. Mean change in the duration of AR symptomsTimepoint: 1. Baseline to Day 15 <br/ ><br>2. Baseline to Day 15
- Secondary Outcome Measures
Name Time Method 1. Mean change in the Total Ocular Symptom Score (TOSS) [Baseline to Final]. <br/ ><br>2. Comparing active and placebo for the mean change in TNSS. <br/ ><br>3. Comparing active and placebo for the mean change in the duration of AR symptoms. <br/ ><br>4. Mean change in AR symptom severity. <br/ ><br>5. Mean change in the serum levels of IgE <br/ ><br>6. Number of times antihistamines were used during the study period as a rescue medication. <br/ ><br>7. Mean change in Patients� Global Impression of Change (PGIC) Scale <br/ ><br>8. Safety outcome by the incidence of AE.Timepoint: 1. Baseline to Final <br/ ><br>2. Baseline to Final <br/ ><br>3. Baseline to Final <br/ ><br>4. Baseline to Final <br/ ><br>5. Baseline to Final <br/ ><br>6. Baseline to Final <br/ ><br>7. Baseline to Final <br/ ><br>8. Baseline to Final <br/ ><br>