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CTRI Number  CTRI/2023/10/059139 [Registered on: 26/10/2023] Trial Registered Prospectively
Last Modified On: 25/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of anutaila instillation in nose and azelastine nasal spray in management of allergic rhinitis. 
Scientific Title of Study   A randomized controlled clinical trial to evaluate the efficacy of Anutaila Nasya and Azelastine Nasal Spray in management of Vataj Pratishyaya. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Somesh Kishor Kawade 
Designation  MS Scholar Shalakyatantra 
Affiliation  PDEAs College Of Ayurved And Research Centre 
Address  Department of Shalakyatantra Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA
411044
India 
Phone  7276757957  
Fax    
Email  someshkawade72@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrManisha Pravin Pingale 
Designation  Associate Professor 
Affiliation  PDEAs College Of Ayurved And Research Centre 
Address  PDEAs College Of Ayurved And Research Centre Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA
411044
India 
Phone  9028360353  
Fax    
Email  manishapingale.mp@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrSomesh Kishor Kawade 
Designation  MS Scholar Shalakyatantra 
Affiliation  PDEAs College Of Ayurved And Research Centre 
Address  Department of Shalakyatantra Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA
411044
India 
Phone  7276757957  
Fax    
Email  someshkawade72@gmail.com  
 
Source of Monetary or Material Support  
PDEAs Ayurveda Rugnalaya and sterling multi-speciality hospital ARSMH, nigadi, pune 
 
Primary Sponsor  
Name  PDEAs College Of Ayurved And Research Centre 
Address  Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044 
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 Somesh Kishor Kawade  PDEAs Ayurveda Rugnalaya and Sterling Multispeciality hospital ARSMH  Department of Shalakyatantra Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA 		 7276757957

someshkawade72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee PDEAs Ayurveda Rugnalaya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: sushrut chikitsa 40-21, Procedure details: Administration of the medicine through Nasal route is known as Nasya. Nasya Karma is the main therapeutic measure of Urdhvajatrugata Roga.)
(1) Medicine Name: anutaila, Reference: charak chikitsa 26-134, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 7 Days
2Comparator Arm (Non Ayurveda)-azelastine nasal sprayIt is a fast-acting, efficacious and well-tolerated H1-receptor antagonist for the treatment of rhinitis. In addition it also has mast-cell stabilizing and anti-inflammatory properties, reducing the concentration of leukotrienes
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients diagnosed with Vataj Pratishyaya showing minimum three sign and syptoms like Nasastrav,
Kshvathu, Nasaavrodh, Pihit nasa and Shirshool.
Age from 18 to 60 will be selected irrespective of sex, socioeconomic status and religion.
Patient Arah for nasya
Patients ready to give written consent for trial and take part in the process of research.  
 
ExclusionCriteria 
Details  Patients with vasomotor rhinitis, acute infective rhinitis, atrophic rhinitis, rhinitis sicca, hypertrophic
rhinitis.
Patients having severe systemic illness
Patients who require surgical interventions
Patients not willing for clinical trial
Patients having associated illness Bronchial Asthma.
Patient Anarah for Nasya.
Patients having complaints of complete or bilateral nasal obstruction.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sample Size 56 Decrease in sneezing,nasal obstruction, watery rhinorrhea and headache.  Sample Size 56 Decrease in sneezing,nasal obstruction, watery rhinorrhea and headache in 2 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in sneezing,nasal obstruction, watery rhinorrhea and headache.  3 months 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   10/11/2023 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study will be intervened by the treatment of Anutaila nasya and Azelastine nasal spray to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of the symptoms. The subjective gradation of symptoms will be done as folllows and the intensity of each symptom will be calculated before treatment after treatment and after follow up. The signs and symptoms will be assessed by proper scoring method. 
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