FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/08/044908 [Registered on: 25/08/2022] Trial Registered Prospectively
Last Modified On: 18/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Pharmaceutical analytical and Clinical pilot trial to evaluate efficacy of Herbal nasal spray in Allergic Rhinitis. 
Scientific Title of Study   PHARMACEUTICAL ANALYTICAL AND CLINICAL STUDY OF HERBAL NASAL SPRAY FOR ALLERGIC RHINITIS – PILOT STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neerja Thakur 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  Room No 106 Department of Rasashastra and Bhaishajya Kalpana Parul Institute of Ayurved Parul University AP limda Tel Waghodia Dist Vadodara Gujarat India

Vadodara
GUJARAT
391760
India 
Phone  9780094524  
Fax    
Email  neerjathakur8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anitha H 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  Room No 106 Department of Rasashastra and Bhaishajya Kalpana Parul Institute of Ayurved Parul University AP limda Tel Waghodia Dist Vadodara Gujarat India

Vadodara
GUJARAT
391760
India 
Phone  9739624874  
Fax    
Email  docvaishnavi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neerja Thakur 
Designation  PG SCHOLAR 
Affiliation  parul institute of Ayurveda 
Address  Room No 106 Department of Rasashastra and Bhaishajya Kalpana Parul Institute of Ayurved Parul University AP limda Tel Waghodia Dist Vadodara Gujarat India

Vadodara
GUJARAT
391760
India 
Phone  9780094524  
Fax    
Email  neerjathakur8@gmail.com  
 
Source of Monetary or Material Support  
Parul institute of Ayurved Parul university Limda Vadodara Gujarat  
 
Primary Sponsor  
Name  Department of Rasashastra and Bhaishajya Kalpana 
Address  Parul institute of Ayurved Parul university 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neerja Thakur  Parul Ayurved Hospital   OPD No 109 Department of Shalakyatantra Parul Ayurved Hospital Parul University AP limda Tel Waghodia Dist Vadodara Gujarat India
Vadodara
GUJARAT 
9780094524

neerjathakur8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
parul institute of ayurved-Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Herbal Nasal Spray, Reference: NA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Herbal Nasal Spray contains a combination of 3 drugs which are Bala (Sida cordifolia, Linn), Adaraka (Zingiber Officinalis Rosc), and Haridra (Curcuma longa Linn).
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Subjects willing for the trial.
2) Mild to moderate cases of Allergic rhinitis.
3) Subject in age group between 18 to 60 years.
 
 
ExclusionCriteria 
Details  1) Subjects not willing for the trial.
2) Subjects below 18 and above 60 years.
3) Cases which require surgical intervention like nasal polyps and deviated nasal septum would be excluded.
4) Patients suffering from any chronic debilitating disease like Tuberculosis, Diabetes mellitus type 2, Asthma and other respiratory or nasal problems.
5)Pregnant ladies and lactating mothers. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of the symptoms of Allergic Rhinitis  Efficacy of treatment will be analyzed by Assessment of symptoms on Gradation like 0, 1, 2, 3. Symptoms are 1)Running nose 2)Nasal blockage 3)Sneezing 4)Headache at baseline and at the end of 7 days. 
 
Secondary Outcome  
Outcome  TimePoints 
CBC
Absolute eosinophilic Count
 
Effect of treatment will be assessed on CBC, Absolute eosinophilic Count at baseline and at the end of 7 days 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   01/09/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Allergic Rhinitis is an atopic disease. Allergy is a type-1 hypersensitivity reaction that produces IgE antibodies to allergens i.e, pollen, dust, cold, and heat. In Ayurveda, various symptoms of Vataja pratishaya like Tanu Nasa Srava, Shirashoola, and Kshavathu are more relevant to symptoms of Allergic rhinitis.
Multiple formulations are administered by different routes to treat allergic rhinitis. Nasal route act on systemic as well as local drug delivery route. Different dosage form through nasal routes includes nasal spray, nasal drops, nasal powders, nasal gels, and nasal inserts.
Long-term use of modern nasal sprays can damage the tissue, causing infection and pain. Sometimes it swells even more than before. If the person continues to use it, this swelling can get more severe and lead to permanent swelling of the tissue. Hence Herbal nasal spray may help to overcome these side effects.   
Ayurveda medicine makes up an important component of the trend toward alternative medicine. Bala is an Ayurvedic medicine that is used to treat Influenza, Headache, Nasal Congestion, Cough, and Wheezing. Secondly, Haridra has been used for ages in different inflammatory conditions of the respiratory tract due to active ingredients like curcumin. Previous research studies proved that Adaraka (Ginger) has alkaloids Gingerol, gingerdione, and zingiberene which are anti-oxidant, antimicrobial, anti-inflammatory, anti-asthmatic, and Mucolytic in action.
The merits of the Nasal delivery route are that it ensures rapid absorption by both systemic and local drug delivery routes. Also, very few preparations of Nasal Spray are available in Ayurveda pharma companies that signify the industrial applicability of the product. Hence, in this present study, an attempt will make to prepare an herbal nasal spray for symptomatic treatment of allergic rhinitis.

 
Close