FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/04/032933 [Registered on: 19/04/2021] Trial Registered Prospectively
Last Modified On: 11/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Management in Rhinitis 
Scientific Title of Study   Comparative Clinical Study To Evalauate The Effect Of Trikatu Avapidana Nasya And Trikatu Taila Nasya On Nasal Mucosa In Vataja Pratishyaya (Allergic Rhinitis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr PADMAN 
Designation  PG Scholar 
Affiliation  Rajiv gandhi university of health sciences bengaluru 
Address  Room No 01 Department Of Shalakya Tantra Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College,Postgraduate Studies And Research Center, Koppal.

Koppal
KARNATAKA
583231
India 
Phone  9845675317  
Fax    
Email  padmanadang@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr VEERAYYA R HIREMATH 
Designation  professor and HOD 
Affiliation  Sri Jagadguru gavisiddeshwara ayurvedic medical college 
Address  Room no 01 Department of Shalakya Tantra Sri Jagadguru gavisiddeshwara ayurvedic medical college,postgraduate studies and research center, koppal.

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drveerurh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr VEERAYYA R HIREMATH 
Designation  Professor and HOD 
Affiliation  Rajiv gandhi university of health sciences bengaluru 
Address  Room No 01 Department Of Shalakya Tantra Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College,Postgraduate Studies And Research Center, Koppal

Koppal
KARNATAKA
583231
India 
Phone  9448544376  
Fax    
Email  drveerurh@yahoo.co.in  
 
Source of Monetary or Material Support  
Department Of Shalakya Tantra 
 
Primary Sponsor  
Name  Department of Shalakya Tantra 
Address  Room No 01 Department Of Shalakya Tantra Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College,Postgraduate Studies And Research Center, Koppal.  
Type of Sponsor  Research institution and hospital 
 
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 
DrPadmaN  Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College  Room No 01 Department Of Shalakya Tantra Sri Jagadguru Gavisiddeshwara Ayurvedic Medical College,Postgraduate Studies And Research Center, Koppal.
Koppal
KARNATAKA 
9845675317

padmanadang@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SJG INSTITUTIONAL ETHICAL COMMITEE  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  
Type  Name  Details 
Intervention  Trikatu Avapidana Nasya   Trikatu Avapidana Nasya for 7 days . 
Comparator Agent  Trikatu Taila Nasya   Trikatu Taila Nasya for 7 days. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients having signs and symptoms of allergic rhinitis(Vataja Pratishyaya)
2.Irrespective of their gender, socio-economic status, educational status and religion.
3.Age group between 7 to 60 years.
 
 
ExclusionCriteria 
Details  1.Patients unfit for Nasya.
2.Patients suffering from nasal polyposis, nasal carcinoma, epistaxis.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
REDUCTION in
1.Watery nasal discharge
2.Nasal obstruction
3.Sneezing
 
7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Complete absence in
1.Watery nasal discharge
2.Nasal obstruction
3.Sneezing
 
37 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   26/04/2021 
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 IgE mediated immunologic response of nasal mucosa to air borne allergens and is characterized by watery nasal discharge, nasal obstruction, sneezing and itching of nose, eyes, palate and pharynx. It is two types they are seasonal and perennial.It is better considered as a unified allergic airway, or even a systematic disease- with inflammatory changes in circulation and bone marrow. More than 10million people are affected by allergic rhinitis in India irrespective of age group. It has negative impact on the quality of life.  Allergic Rhinitis may be compared with Vataja Pratishyaya, characterized by watery nasal discharge, nasal blockage, difficulty in breathing, dryness of throat, palate, lips along with pricking type of pain in temporal region and change in voice and sneezing .

            Allopathic Treatment involves oral administration of anti-histamine, alpha-adrenergic and corticosteroid drugs, which have side effects like drowsiness, rhinitis medicamentosa and mucosal atrophy respectively, other treatment modalities includes avoidance of allergen and immunotherapy. Immunotherapy shows no clinical improvement after prolonged usage.

In Vataja Pratishyaya treatment protocol of Ardita, Vataja Kasa, and Pinasa are advocated. It includes Sneha Dhuma, Swedana, Upanaha, Anutaila Nasya , Avapidana Nasya, Pradhamana Nasya, Asthapana Basti.Intake of Ghrita , Maricha with Guda, and Vyoshadi Vati.

           Since, both Taila and Avapidana Nasya are advocated in management of Vataja Pratishyaya, this study is aimed to compare the effect of Trikatu Taila and Trikatu Avapidana Nasya on nasal mucosa in the management of Vataja Pratishyaya.    

 
Close