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CTRI Number  CTRI/2025/01/079313 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   A Clinical Study To Evaluate The Efficacy Of Jala Neti (nasal cleansng procedure) In The Management Of Vataj Pratishayaya W.S.R. To Allergic Rhinitis. 
Scientific Title of Study   A Clinical Study Of Efficacy Of Jala Neti (Nasal Cleansing Procedure) In The Management Of Vataj Pratishayaya W.S.R. To 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 Tanmay pandhari kashiwar  
Designation  PG scholar  
Affiliation  Bhausaheb mulak ayurvedic medical College, nagpur  
Address  OPD,Department of swasth rakshan,Bhausaheb mulak ayurvedic medical College and research centre,nandanvan, nagpur.

Nagpur
MAHARASHTRA
0170
India 
Phone  9309926887  
Fax    
Email  tanmay12kas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhavi V Rehpade  
Designation  H.O.D. Dept. Of Swasthvritta 
Affiliation  Bhausaheb mulak ayurvedic medical College, nagpur  
Address  OPD,Department of swasth rakshan,Bhausaheb mulak ayurvedic medical College and research centre,nandanvan, nagpur.

Nagpur
MAHARASHTRA
0170
India 
Phone  9422146204  
Fax    
Email  madhavi309@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Madhavi V Rehpade 
Designation  H.O.D. Dept. Of Swasthvritta 
Affiliation  Bhausaheb mulak ayurvedic medical College, nagpur  
Address  OPD,Department of swasth rakshan, Bhausaheb mulak ayurvedic medical College and research centre,nandanvan, nagpur.

Nagpur
MAHARASHTRA
0170
India 
Phone  9422146204  
Fax    
Email  madhavi309@yahoo.co.in  
 
Source of Monetary or Material Support  
OPD of swasth rakshan, Bhausaheb mulak ayurvedic medical College nandanvan nagpur.dist -nagpur ,state -Maharashtra, country - India,pin code-440024 
 
Primary Sponsor  
Name  Bhausaheb mulak ayurvedic medical College Nandanvan Nagpur  
Address  Bhausaheb mulak ayurvedic medical College,Great road Nagpur ,Nandanvan Nagpur. Pin code- 440024 
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 Tanmay pandhari kashiwar   Bhausaheb mulak ayurvedic medical College Nandanvan, Nagpur-09,pin code-440024  OPD , No.5 swasth rakshan department, Bhausaheb mulak ayurvedic medical College nandanvan nagpur , pincode -440024
Nagpur
MAHARASHTRA 
9309926887

tanmay12kas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS commitee of institute,BMAM nagpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Jala neti, Pathya/Apathya:yes, Pathya:1. Yusha of munga,masur or unripe radish should be taken during lunch and dinner ( Ashtang Sangraha)26 2. To take a fortified milk with Pippali,Dashmula,Shuntha,Satu and Eerand Mula should be taken. 3. To take a Laghu Aahara. 4. Hot water should be taken for drink and bath. 5. Stay in Nirvata and warm atmosphere. 6. Gramya Masarasa fortified with Ushna and Amla Dravya should be taken., Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patient have symptoms of Vataja Pratishyaya like
Nasaavarodh,Nasastrav,Nasakandu,Kshwathu as explained in classical
Text books. 
 
ExclusionCriteria 
Details  1. Patient with bleeding from nose will be excluded.
2. Patient with DNS (deviated nasal septum). COPD(chronic obstructive
pulmonary disease),bronchial asthama and other severe respiratory
disease like status asthmatics.
3. Patient with chronicity more than 3 years.
4. Cases which require surgical treatment like a Nasal Polyps.
5. Patient with Pregnancy and Lactating mother. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Jala neti as nasal cleansing procedure on Nasaavrodh (nasal congestion),Nasastrav(rhinorrhea),Nasakandu(nasal itching),Kshwathu(sneezing )in management of Vataja Pratishyaya(allergic rhinitis).   For 1 month  
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of jala neti in the management of vataja Pratishayaya.
To study Vataja Pratishyaya disease.
To study the jala neti procedure. 
At 0th ,10th,20th,30th Days 
 
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 3 
Date of First Enrollment (India)   10/02/2025 
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="0"
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   Ayurveda is a science of life which always emphasizes on maintenance of
healthy body, in fact its first aim itself, is preservation and protection of
normal health. To fulfil this aim respected acharya focused on
swasthavritta to maintain method of keeping life healthy.
Pratishyaya is one of the ancient diseases. During the period of Atharva
Veda, words vekelandu, vilohita, devakosha were used for Pratishyaya1
.
Detailed description of Pratishyaya is found in Samhitas. Pratishyaya is a
disease characterized by shyaya or secretion through nose. It is correlated
with allergic rhinitis in the present day. Allergic rhinitis is the most common
chronic condition, with an estimated prevalence in the United States of
5%–22%, which increases from infancy, peaks in childhood and
adolescence, and decreases in the elderly2
. The pollution is increasing day
by day due to manmade environmental changes and over utilization of
natural resources. These changes cannot be avoided, so the best way to
tackle them is by enhancing the internal healing power by means of a
healthy diet and change in lifestyle. Yoga is one of the ideal ways to
prevent and cure pratishyaya and it also has a positive side effect, i.e.,
stress relieving effect, by which one can also prevent many dreaded
diseases like hypertension, diabetes mellitus, etc.According to Yoga, any
obstruction or derangement in the flow of prana due to accumulation of
toxins results in diseases. Human body is formed of 5 types of koshas as
per Upanishads. Annamaya kosha (food sheath), pranamaya kosha (pranic
sheath),manomaya kosha (mental sheath), vijnanamayakosha(gnostic
sheath) and anandamaya kosha (bliss sheath)3
.
Hathayoga Pradipika considers that the body is made up of 72000 nadis
through which the pranic energy flows4
. Any derangement in the flow of this pranic energy due to accumulation of mala (waste or foreign body)
results in disease. Anurjata or allergy is a result of weakened immune
system; hence, purification of nadis (channels) through samanu and
nirmanu nadishuddhi and bringing about strength, steadiness, calmness, in
the body by the practice of shatkarma (especially neti and kapalabhati),
asana, pranayama, dhyana, etc. A great strength develops through
harnessing of inner vital energies and training different organs and systems
to work in coordination. These help in both managing and preventing
allergic rhinitis5
.
Yoga is a group of Physical,Mental & Spiritual practices or disciplines which
originated in ancient India. Neti is an important part of Shatkarma. The
yogic system of body cleansing techniques. It is intended mainly to clean
the air passage. Ayurveda is a system of medicine with historical roots in
the Indian subcontinent. Ayurveda therapies and practices have been
integrated in general wellness application and in some cases in medical
uses.
Rational of
study
 Due to urbanization and vast urban development, there is increase
in air pollution, persistent humid atmosphere, respiratory infections are
reported in large numbers in general medical practice and even though
exact statistical data are not available, large number of patients with
problem of allergic rhinitis, sinusitis also comes in OPD of any hospitals.
Ayurveda science mentioned air pollutants like Raja, Dhooma as causative
factors of respiratory illness including Allergic Bronchitis (Shwasa), Allergic
rhinitis (Pratishyaya), Cough (Kasa) and Hiccough (Hikka).
Pratishyaya/allergic Rhinitis occurs much more frequently than before. In
this condition once sinus is infected improper management negligence by
patients and faulty dietary habits lead the disease into a chronic phase. An
Indian study reported that prevalence of allergic rhinitis 10-30% of adults
and 40% of children of population. In modern medical science, quite
effective and wide range of antibiotics and decongestants are available but
these drugs can help only in the initial stage, the modern treatment
modalities for allergic rhinitis are expensive and not free from side effects.
A lot of treatment modalities are also explained by Acharya’s in Ayurveda
for this disease according to the condition of patient and progressions of
disease. All Acharya’s have described pratishyaya treatment according to
Dosha-Dushyasamurchhana.
 In Gherand samhita and hathyog pradipika there is one
wander ‘jala neti suddhi kriya’ given and advised it’s Jala Neti in
urdhwajatrugata roga. Hence the study titled as "A Clinical Study Of
Efficacy Of Jala Neti (Nasal Cleansing Procedure) In The Management Of
Vataja Pratishayaya W.S.R. To Allergic Rhinitis.”
Objectives – 8.1 Primary Objective-
To study the effect of Jala neti in management of Vataja Pratishyaya.
8.2 Secondary Objective-
To study Vataja Pratishyaya disease.
To study the jala neti procedure.
Assessment Criteria
Subjective parameters
Based on sign & Symptoms of Allergic Rhinitis – Total Nasal Symptoms
Score 14
1. Nasal obstruction (Nasa avrodh)
2. Rhinorrhea (Nasastrav)
3. Nasal itching (Nasa kandu)
4. Sneezing (kshwathu)
Objective Parameters
6. Absolute Eosinophil count (CBC)
Parameters for
assessment of
study
outcomes
Overall Effect of Therapy (Overall Assessment Criteria) :-
Overall assessment will be done by following -
1. Not cured - No improvement in subjective Criteria
2. Improved - Improvement in Subjective criteria
3. Cured - Improvement in Subjective criteria
Efficacy of
Treatment
(Jalaneti)
Total Nasal
Symptoms
Score (Grade)
Total assessment
Excellent 0 100% Relief in sign &
symptoms
Very mild 1-3 75-99% Relief in sign
& symptoms
Mild 4-6 50- 75% Relief in
sign & symptoms
Moderate 7-9 25-50% Relief in sign
& symptoms
Severe
(Infective)
10-12 0-25% Relief in sign
& symptoms.
Total Nasal Symptoms Score (TNSS)
Minimum Score – 0
Maximum Score – 12
 
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