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CTRI Number  CTRI/2021/11/038028 [Registered on: 15/11/2021] Trial Registered Prospectively
Last Modified On: 11/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial of jala neti and kapalabhati on Allergic Rhinitis 
Scientific Title of Study   Effect of Jala Neti and Kapalabhati on Allergic Rhinitis(Pratishyaya) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajesh Ranjan 
Designation  Research Scholar 
Affiliation  Institute of Medical Sciences-BHU 
Address  Department of Swasthavritta & Yoga, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005 U.P.- India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9140767657  
Fax    
Email  rajesh.pragyaputtra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Neeru Nathani 
Designation  Professor & Head 
Affiliation  Institute of Medical Sciences-BHU 
Address  Department of Swasthavritta & Yoga, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005

Varanasi
UTTAR PRADESH
221005
India 
Phone  9454187783  
Fax    
Email  nsneeru@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Rajesh Ranjan 
Designation  Research Scholar 
Affiliation  Institute of Medical Sciences-BHU 
Address  Department of Swasthavritta & Yoga, Institute of Medical Sciences, Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9140767657  
Fax    
Email  rajesh.pragyaputtra@gmail.com  
 
Source of Monetary or Material Support  
Department of Swasthavritta and yoga, Institute of Medical Sciences-BHU 
 
Primary Sponsor  
Name  Department of Swasthavritta and Yoga Institute of Medical SciencesBHU 
Address  Banaras Hindu University Varansi-221005(U.P.) 
Type of Sponsor  Research institution 
 
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 
Rajeev ranjan  OPD Yog Arogya Kendra  Department of Naturopathy kaali Mandir pandeypur Pandeypur
Varanasi
UTTAR PRADESH 
7753832359

yogarogyakendra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Medical Sciences-BHU  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
1Intervention ArmProcedure-Jalneti kriya and Kapalbhati (Procedure Reference: , Procedure details: (Procedure Reference: , Procedure details: jalneti kriya with saline water followed by kapalbhati and kapalbhati))
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients showing and Symptoms of Allergic Rhinitis(Pratishyaya) 
 
ExclusionCriteria 
Details  Epistaxis, nasal polyp, tumour, other chronic diseases, earlier nasal surgery, pregnant women, DNS. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
T4SS (Total 4 Symptom Score) and (RQLQ) Rhino-conjunctivitis Quality of Life Questionnaire   Outcome will be done at baseline, and after 15 days, 1 month and 2 months  
 
Secondary Outcome  
Outcome  TimePoints 
Blood Test(CBC)  Assessments will be done at baseline, and after 15 days, 1 month and 2 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   N/A 
Date of First Enrollment (India)   15/11/2021 
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="0"
Months="6"
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 a common respiratory problem  occurs due to change of seasons or dust, pollens cold, mist allergy etc. It is characterized by nasal congestion, itching, sneezing ad rhinorrhea its prevalence is increasing with industrialization urbanization and environment pollution. Allergic Rhinitis may also be associated with Bronchial Asthma, Sinusitis, Atopic dermatitis, Allergic Conjunctivitis etc. The global prevalence it  10% to 30% for adult and as high as 40% for children. About 500 million people suffer from Allergic Rhinitis across the world.

Allergic Rhinitis can be correlated with Pratishyaya in Ayurveda. In which mainly Vata and Kapha get vitiated. It is characterized by symptoms like headache, heaviness, anosmia, fever, cough ,hoarseness of voice, anorexia, tiredness, impaired functions of sense organs and Yakshama (emaciation). In Ayurveda, for prevention and cure of Pratishyaya the holistic approach has been advocated through various daily and seasonal regimens.

Our nose is highly developed sensory organ playing a sentinel role to balance the respiratory system.The mucociliary layer of nostrils actively participates in respiratory homeostasis by ciliary function, mucus secretion and inflammatory response. The integrity of respiratory mucosa is essential for airways to fulfill their role. Nasal hygiene relieves congestion, reduces viscosity of mucus and keeps nasal cavity clean and moist. For this, the sprays, lavage and irrigation are being used.

The conventional therapy for allergic rhinitis mainly follows the long-term use of antihistamines and intranasal corticosteroid sprays It mostly causes nasal dryness or bleeding and drowsiness, and higher recurrence rate after medication.

There are various yoga procedures associated with proven health benifits.Yoga is primarily a spiritual discipline, leads to union of individual consciousness with the Universal Consciousness. This is an art and science of healthy living, focuses on bringing harmony between body, mind and spirit. Out of various streams of Yoga the Hath yoga is more popular in modern society. It is based on physical practices viz. shatkarma, asana, pranayama, mudra, bandh etc. In leading texts of Hath Yoga the Shatkarma have been described before Asana and Pranayama. Shatkarma are six purificatory procedures for cleansing of different body parts. These are Dhauti, Basti, Neti, Nauli, Trataka and Kapalabhati.Jal neti and kapalbhati are described in hath yoga text to control the condition such rhinitis and sinusitis. The Jala Neti kriya, using saline water, helps to remove the infected mucous from nasal sinuses. Practice of Kapalbhati after Jala Neti kriya, expels the stagnated water and mucous and dries up the nasal sinuses by increasing mucosal temperature.

These practices also remove the toxins from the body and in the resistance of nasal mucosa against the allergens and microorganisms, hence considered to be beneficial in Allergic Rhinitis. So keeping these facts into consideration the study  entitled “EFFECT OF JALA NETI AND KAPALBHATI ON ALLERGIC RHINITIS (PRATISHYAYAY)" has been proposed. 
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