To evaluate the efficacy andsafety of Nigellin in individuals with allergic rhinitis

Recruiting

Brief Summary: a) All the participants who meet the inclusion and exclusion criteria will be enrolled in the study.

b) As per the randomization schedule, enrolled participants will receive either active or placebo capsules for a period of 15 days.

c) Patient visits will be as follows on Screening & Baseline Visit- visit 1(Day 0), Visit 2 (Day 5), & Visit 3 (Day 15) +/- 2 days.

d) Only levocetirizine is allowed to take during the study period.

e) Telephonic follow-up will be done on day 21 and day 30 from the last visit to know the Adverse event and overall well-being of the patients by filling patient diary.

Recruitment & Eligibility

Inclusion Criteria

Male or Female in the age of 18 to 60 years.
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.
Patients with a medical history of allergic rhinitis.
Voluntary written consent.

Exclusion Criteria

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.
Concomitant steroid, anticoagulant, and immunotherapy within the past 1 month.
Impaired haematological profile and liver / renal function.
Known alcohol and / or drug abuse.
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.

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.	1. Baseline to Day 15 \| 2. Baseline to Day 15
1.Mean change in the Total Nasal Symptom Score (TNSS)	1. Baseline to Day 15 \| 2. Baseline to Day 15
2. Mean change in the duration of AR symptoms	1. Baseline to Day 15 \| 2. Baseline to Day 15

Secondary Outcome Measures

Name	Time	Method
1. Mean change in the Total Ocular Symptom Score (TOSS) [Baseline to Final].	2. Comparing active and placebo for the mean change in TNSS.

Locations (2): BGS Global Institute of Medical Sciences
🇮🇳
Bangalore, KARNATAKA, India
MEDSTAR Speciality Hospital
🇮🇳
Bangalore, KARNATAKA, India
BGS Global Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Harshith CS
Principal investigator
9972539315
harsh0594@gmail.com