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CTRI Number  CTRI/2024/12/078578 [Registered on: 26/12/2024] Trial Registered Prospectively
Last Modified On: 06/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Shigru Taila Nasya and Anu Taila Nasya in management of Vataja Pratishaya (Allergic Rhinitis) 
Scientific Title of Study   A Comparative Clinical Trial to Study the Effect of Shigru Taila Nasya and Anu Taila Nasya in management of Vataja Pratishaya (Allergic Rhinitis) 
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 Vaibhav Vishnu Shinde  
Designation  MD Swasthavrittha Scholar 
Affiliation  Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule 
Address  Department of Swasthavrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule

Dhule
MAHARASHTRA
424002
India 
Phone  9923824106  
Fax  -  
Email  vaibhavshinde191998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varsha P Jaraje  
Designation  MD Swasthavrittha 
Affiliation  Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule 
Address  Department of Swasthvrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule

Dhule
MAHARASHTRA
424002
India 
Phone  9960140809  
Fax    
Email  varshajaraje@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varsha P Jaraje  
Designation  MD Swasthavrittha 
Affiliation  Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule 
Address  Department of Swasthvrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule

Dhule
MAHARASHTRA
424002
India 
Phone  9960140809  
Fax    
Email  varshajaraje@gmail.com  
 
Source of Monetary or Material Support  
Department of Swathavrittha ,Smt K C Ajmera Ayurved Mahavidyalya Deopur,Dhule,Maharastra,India pin code - 424002 
 
Primary Sponsor  
Name  Smt K C Ajmera Ayurved Mahavidyalya DeopurDhule 
Address  Department of Swasthavrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule Dhule ,MAHARASHTRA ,India pin code - 424002 
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 Vaibhav Vishnu Shinde  Smt K C Ajmera Ayurved Mahavidyalya and hospital Deopur, Dhule  Department of Swasthavrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule Dhule Maharashtra ,India pin code424002
Dhule
MAHARASHTRA 		 9923824106

vaibhavshinde191998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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: VATAJAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Agnivesh, Vidyotini Hindi Commentry By Pandit Kashinath Shastri, Dr.Goraknath Chaturvedi , Charak Samhita , Purvardha Sutrasthan Adhyaya 30 , Shlok 26 , Varanasi Chaukhamba Bharti Academy Reprint 2002 Page No 587, Procedure details: Administration of Nasya – The patient will be asked to lie down in supine position with head low and tip of the nose facing towards the roof of room. • Nasya medicine will be warmed by keeping it in warm water vessel. • Patient’s eyes will be covered with cotton so as to prevent the spilling of Taila inside the eyes during instillation • While instilling the medicine in one nostril other nostril will be kept closed by index finger of left hand and thumb. • After the administration of Nasya Drug Kaval with Koshna Jal will be done.)
(1) Medicine Name: Shigru Taila Nasya, Reference: Vangasen Samhita Chikitsasar sangraha , Prachya Prakashan Varanasi , Nasarogadhikar Adhyaya Shlok no 102, pg.no 598, Route: Nasal, Dosage Form: Taila, Dose: 4(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Patients Of age group 20 years to 60 years will be selected for study
2.Both male and female, patients having classical signs and symptoms of Vataja Pratishyaya (Allergic Rhinitis) irrespective of their socioeconomic status, educational status, caste and religion.
3.Patient who will fullfill the diagnostic criteria of Vataja Pratishyaya.
4. Nasya Arha. 
 
ExclusionCriteria 
Details  1
Patients below age group of 20 years and above 60 years.
2
Patient Having previous history of nasal surgery.
3
Patients suffering from nasal polyp, nasal carcinoma, DNS, history of nose trauma.
4
Patients with previous history of head trauma, Intracranial surgery.
5
Pregnant women, Sutika (women in post-natal care)
6
Patients taking any kind of medicine like Corticosteroids, antihistamine, anti-inflammatory, topical corticosteroid.
7
Patients with any major systemic illness
8
Patients with history of alcohol or substance abuse.
9
Patients having history of any Autoimmune Disease 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Kshavathu (Sneezing) Should Decreased
2)Tanusrav (Runny Nose)Should Decreased
3)Aanadhava (Nasal Blockage)Should Decreased
4)Shirashool (Headache) Should Decreased 		 21 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
1) Galashotha (Dryness of throat)Should Decreased
2) Nistodhankha (Pricking Pain in Temporal Region) Should Decreased
3) Swarabheda (Hoarseness of Voice) Should Decreased 		 45 DAYS 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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/ Phase 3 
Date of First Enrollment (India)   13/01/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  
Due to a lot changes in this modern era, as changes have come in life style, living habits, pollution, and environmental changes, people are getting more affected to disease, due to their weak immune system, which causes disturbed in routine life-style
In this 21st generation people are more prone to allergic disease due to environmental changes, lifestyle changes and pollution disease like dryness of eyes, allergic bronchitis, allergic skin diseases and allergic rhinitis. Allergic reaction is produced when the body comes in contact with allergens little dust, dander, pollens then certain chemicals are produced in the body called histamines which releases into the blood stream and produces symptoms like excess mucus production, swelling of affected tissues, itching, sneezing, rashes Modern science described allergic disease in detail considering an allergens little dust, dander, pollens are cause for allergic disease.
The disorder of Nasa has been described widely by all acharyas; Acharya Sushrut had described Nasa Gatha Rogas among them Pratishyaya is one of the most important diseases.
Allergic rhinitis has symptoms like Watery nasal discharge, Sneezing, Itching in the nose, Runny nose, Watery eyes, Nasal congestion, Stuffy nose, Redness, Headache, Throat irritation, 
Vataja Pratishyaya can be correlated to allergic rhinitis because most of the signs and symptoms such as Nasagata Tanustrava (Watery nasal discharge), Kshavathu (sneezing) and Nasaavarodha (Nasal obstruction), Shirogaurav (Headache), Kandu (Itching in nose & eye) are similar as found in Vataja Pratishaya.

As per Charakacharya, Nasya is explained at Matrashitiya adhyay.11 Nasya is administrated in nasal cavity by drop.

पिबेव्दातप्रततशाये सपििर्ाितघ्नसाधितम ।
िटुिंचकससध्दं र्ा पर्दयािददगणेन र्ा।
स्र्ेदनस्याददकां कुयािच्चचककत्सामददितोददताम॥
अ.हृ.उ.२०/९-१

The treatment of Vataja Pratishaya is Vatashaman, specially Vataghna dravya, Nasya karma, Grutha prepared can be used 13 from these principles we are going to use Nasya karma, Nasya has significant role of Urdvajatrugata roga hence research will focus on administration of Nasya.
According to Ayurvedic text Shigru Taila nasya in Pratishyaya.

सशग्रुकान्तार्चाव्योषद्राक्षासुरससैन्िर्ैैः ।
नस्यदानाज्जयेच्स्तद्िं तैलं नासागदे नृणाम् ।। र्ंगसेन

As Pratishyaya is Vaat and Kapha dominance disease, and in Vataja pratishyaya ,Vaat is the main dosha. And Shigru Taila having contents which are predominantly Vatakaphashamak Shigru Taila will be used according to reference of Vangasen
Nasya karma is the main therapeutic measure of Urdhvajatrugata roga Nasya with Shigru Taila will provide proper relief from symptoms like Running Nose, Sneezing, Blockage, Headache, itching etc.

I. Null hypothesis (H0)
Effect of Shigru taila Nasya is not significant than Anu Taila Nasya in management of Vataja Pratishyaya (Allergic Rhinitis).

II. Alternate Hypothesis (H1)
Effect of Shigru taila Nasya is significant than Anu Taila Nasya in management of Vataja Pratishyaya (Allergic Rhinitis).
 
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