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CTRI Number  CTRI/2025/02/081273 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   TO COMPARE EFFECTIVENESS OF SALINE NASAL IRRIGATION AND HONEY WATER NASAL IRRIGATION IN TREATMENT OF ALLERGIC RHINITIS. 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF JALA NETI AND MADHU NETI IN MANAGEMENT OF ALLERGIC RHINITIS VIS A VIS 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 Vandana Balakrishna Patil 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and hospital,Mysuru 
Address  Department of swasthavritta, Government Ayurveda Medical College and Hospital,Visvesvaraya Circle, Devaraja Mohalla,Mandi Mohalla Mysore KARNATAKA

Mysore
KARNATAKA
570001
India 
Phone  08698252013  
Fax    
Email  vandanagamc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudheendra G Nawale 
Designation  Professor 
Affiliation  Government Ayurveda Medical College and hospital,Mysuru 
Address  Department of swasthavritta, Government Ayurveda Medical College and Hospital,Visvesvaraya Circle, Devaraja Mohalla,Mandi Mohalla Mysore KARNATAKA

Mysore
KARNATAKA
570001
India 
Phone  9341061821  
Fax    
Email  sudhi130207t@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vandana Balakrishna Patil 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College and hospital,Mysuru 
Address  Department of swasthavritta, Government Ayurveda Medical College and Hospital,Visvesvaraya Circle, Devaraja Mohalla,Mandi Mohalla Mysore KARNATAKA

Mysore
KARNATAKA
570001
India 
Phone  08698252013  
Fax    
Email  vandanagamc@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital, Visvesvaraya circle,Devaraja Mohalla,Mandi Mohalla, Mysuru, Karnataka 570001 
 
Primary Sponsor  
Name  Dr Vandana Balakrishna Patil 
Address  Government Ayurveda Medical College and Hospital, Mysuru 
Type of Sponsor  Other [Self] 
 
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 Vandana Balakrishna Patil  Government Ayurveda Medical College and Hospital   Room no 12 Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital
Mysore
KARNATAKA 
08698252013

vandanagamc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda Medical College and hospital Mysuru  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
1Comparator ArmProcedure-Madhuneti (Procedure Reference: Previous study by Dr Archana Inchekar 1997 to 2001 Kerala University, Procedure details: 1 Fill the Neti pot with lukewarm Honey water. 2 Stand with the legs apart. 3 Hold the Neti pot in your right hand. 4 Insert the nozzle of the Neti pot into the right nostril. 5 Keep the mouth open & breathe freely through the mouth. 6 Tilt the head first slightly backward, then bend forwards & move the neck sideward to the right so that the water from the pot enters the right nostril & comes out through the left by gravity. Allow the flow till the pot is empty. 7 Repeat the same on the left side. 8 To clear the nasal passages of the remaining water, blow out the water by active exhalation through alternate nostrils. Post procedure - Kapalabhati 2 to 3 rounds)
2Intervention ArmProcedure-Jalaneti (Procedure Reference: Hatayoga Pradeepika 2/21 and 2/30, Procedure details: 1 Fill the Neti pot with lukewarm saline water. 2 Stand with the legs apart. 3 Hold the Neti pot in your right hand. 4 Insert the nozzle of the Neti pot into the right nostril. 5 Keep the mouth open & breathe freely through the mouth. 6 Tilt the head first slightly backward, then bend forward & move the neck sideward to the right so that the water from the pot enters the right nostril & comes out through the left by gravity. Allow the flow till the pot is empty. 7 Repeat the same on the left side. 8 To clear the nasal passages of the remaining water, blow out the water by active exhalation through alternate nostrils. Post Procedure Kapalabhati 2-3 rounds.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Subjects having age groups between 18 to 50 years. irrespective of caste religion and genders.
2 Subjects having classical symptoms of Allergic rhinitis.
3 Subjects having willing to participate in study 
 
ExclusionCriteria 
Details  1 Subjects having recent surgical history.
2 Subjects having Nasal growths Severe DNS Asthma Prone to Ear infection.
3 Uncontrolled Hypertension Uncontrolled Diabetes Mellitus or any other systemic disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 To evaluate the effect of Jala Neti in the management of Allergic rhinitis (Pratishyaya)
2 To evaluate the effect of Madhu Neti in the management of Allergic rhinitis (Pratishyaya) 
16 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of Jala Neti and Madhu Neti in the management of Allergic rhinitis (Pratishyaya)  16 Days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3 
Date of First Enrollment (India)   15/03/2025 
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)   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  

Allergic rhinitis is a disorder in which there are episodes of nasal congestion, watery nasal discharge and sneezing, may be associated with conjunctival and pharyngeal irritation and sinusitis, It may be due to an immediate hypersensitivity reaction in the nasal mucosa. Allergic rhinitis is a common problem in today’s world, currently from the overall population approximately 10-30% of adults and 40% of children are affected.In India, approximately 22% of adolescents currently suffer from allergic rhinitis. Although Allergic rhinitis is not a fatal condition, it is associated with impaired quality of life, absenteeism from work, and substantial financial costs. The Contemporary treatments are antihistamines and anti-allergic drugs although they have quick action when these fail to control symptoms or produce intolerable side effects, Alternative Medical sciences like Yoga can be helpful in management.

The Causative factors and symptoms of Allergic Rhinitis have similarities with Pratishyaya, which is a Nasagata Roga. Sushruta Samhita explained Pratishyaya as a condition in which Kapha, Pitta, and Rakta along with Vata accumulate in the head region. The etiological factors for Pratishyaya are Rajo Sevana, Ritu Vaishamya, Avashyaya and Dhooma, This helps us to correlate it with Allergic rhinitis. If Pratishyaya is not treated  properly, it leads to a severe and complicated condition called Dushta Pratishyaya. which is difficult to manage. Pratishyaya is an Urdhwajatrugata Roga and Neti is beneficial in curing ailments involved in the supraclavicular region.

Hata Yoga Pradipika and Gherand Samhita described Shatkarma as six purificatory procedures to be practiced when kapha and Medas are in excess (Dhauti, Basti, Neti, Nauli, Trataka, Kapalabhati). Neti is a technique to cleanse the nasal passages. Neti cleanses Kapala, gives clear vision and alleviates disease which manifest above the root of the neck. Repeated irrigation of the nasal passage helps in reducing congestion in the nasal passage and swelling. Saline nasal irrigation can significantly improve symptoms of Allergic rhinitis in children and adults, it can serve as a safe adjacent treatment in adults.  Honey used in madhu neti  has a potential therapeutic role in the treatment of disease by anti-inflammatory, antibacterial and antioxidant properties. According to Sushruta Samhita, the qualities of honey are Shodhana, Ropana, Prasadana, Sukshmamarganusari, Kaphaghna and Tridosha-prashamana.

        In current study we are trying to compare the efficacy of Jala neti and madhu neti in the management of Allergic rhinitis vis a vis Pratishyaya.

 
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