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CTRI Number  CTRI/2022/07/044180 [Registered on: 20/07/2022] Trial Registered Prospectively
Last Modified On: 21/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the efficacy and safety of Nigellin in individuals with allergic rhinitis 
Scientific Title of Study   A randomized, single-blind, placebo-controlled study to evaluate the efficacy and safety of Nigellin in individuals with allergic rhinitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CW/106/NIG_ALRH/I/JAN/22 Day Month Year :31-May-2022 Ver 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshith CS 
Designation  Assistant Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  BGS Global Institute of Medical Sciences #67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bengaluru

Bangalore
KARNATAKA
560056
India 
Phone  9972539315  
Fax    
Email  harsh0594@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shaji Paulose 
Designation  General Manager 
Affiliation  Sami-Sabinsa Group Limited  
Address  Sami-Sabinsa Group Limited 19/1 & 19/2 I Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  shaji@clinworld.net  
 
Details of Contact Person
Public Query  
Name  Dr Alphons Philips 
Designation  Vice President 
Affiliation  Sami-Sabinsa Group Limited 
Address  Sami-Sabinsa Group Limited 19/1 & 19/2 I Main, Peenya II Phase, Peenya, Bengaluru, Karnataka 560058

Bangalore
KARNATAKA
560058
India 
Phone  08028397973  
Fax    
Email  alphons@clinworld.net  
 
Source of Monetary or Material Support  
Sami-Sabinsa Group Limited 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560058. 
 
Primary Sponsor  
Name  Sami Sabinsa Group Limited 
Address  19/1 & 19/2, I Main, Peenya II Phase, Bengaluru, Karnataka 
Type of Sponsor  Other [[Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshith CS  BGS Global Institute of Medical Sciences  #67, BGS Health and Education City, Uttarahalli Road, Kengeri,Bengaluru
Bangalore
KARNATAKA 		 9972539315

harsh0594@gmail.com 
Dr Chikkalingaiah Siddegowda  MEDSTAR Speciality Hospital   #641/17/13, Kodigehalli Main road, Sahakarnagar, Bangalore 560092
Bangalore
KARNATAKA 		 9844004187

drchikkalingaiahmedstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committe  Approved 
Medstar Speciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo (control) arm – 250 mg   twice a day after food 
Intervention  Test Arm – Nigellin® AMBER 250 mg for 15 days  twice a day after food form for 15 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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 symptoms  		 1. Baseline to Day 15
2. Baseline to Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
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 Patients’ Global Impression of Change (PGIC) Scale
8. Safety outcome by the incidence of AE. 		 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
 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
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.
 
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