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CTRI Number  CTRI/2011/12/002289 [Registered on: 25/12/2011] Trial Registered Prospectively
Last Modified On: 19/12/2011
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Jalneti and Pranayam on sinusitis 
Scientific Title of Study   Effect of Yogic kriyas and pranayama in managing symptoms of rhino sinusitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Babina N 
Designation  Project officer 
Affiliation  INYSMRS 
Address  Institute of Naturopathy and Yogic sciences Medical Research Society. Jindal Nagar Tumkur Road Bangalore

Bangalore
KARNATAKA
560073
India 
Phone    
Fax    
Email  dr.babina@jindalnaturecure.org  
 
Details of Contact Person
Scientific Query
 
Name  DrAvinash Kadam 
Designation  Sr.Research Associate 
Affiliation  INYSMRS 
Address  Institute of Naturopathy and Yogic sciences Medical Research Society. Jindal Nagar Tumkur Road Bangalore

Bangalore
KARNATAKA
560073
India 
Phone    
Fax    
Email  inysmrs@jindalnaturecure.org  
 
Details of Contact Person
Public Query
 
Name  Drmahesh Kamal 
Designation  Junior Research officer 
Affiliation  INYSMRS 
Address  Jindal Charitable hospital. Rajaji Nagar Bangalore

Bangalore
KARNATAKA
560010
India 
Phone    
Fax    
Email  ma.ka.drs@gmail.com  
 
Source of Monetary or Material Support  
Funding from Institute of naturopathy and yogic sciences medical research society .(INYSMRS) 
 
Primary Sponsor  
Name  Institute of Naturopathy and Yogic sciences Medical Research societyINYSMRS 
Address  Jindal Nagar. Tumkur Road Bangalore-73 
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 
DrMahesh Kamal  Naturopathy OPD ,Jindal Charitable Hospital  Above Rajaji Nagar RTO Behind Navarang Cinema Rajaji Nagar
Bangalore
KARNATAKA 
8105680293

ma.ka.drs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics comitee INYSMRS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Rhinosinusitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Jalneti with hypertonic nasal saline (concentration 0.9% )   Jalneti will be followed by kapalbhati 
Comparator Agent  waitlist control  They will continue to receive nasal decongestants and standard of care during the waitlist period of 4 weeks and then receive nasal irrigation for next 4 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details 
1. Male and female patients with age in range of 18 years to 60 years
2. Diagnostic criteria (as per recommendations of Task Force of Rhinosinusitis-1997)
 
 
ExclusionCriteria 
Details  1. Patients taking intranasal steroids
2. Patients with glaucoma, epistaxis
3. Patients with uncontrolled hypertension
4. Those with middle ear infections, tinnitus, vertigo etc.
5. Head and neck malignancy and h/o CVA
 
 
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 
Evaluation of symptoms by SNOT and Total Nasal Symptom Score  The outcome measures will be checked on Day 0 (baseline), Day 10 (mid intervention) and Day 21 (post intervention). 
 
Secondary Outcome  
Outcome  TimePoints 
Mucociliary Transit time using Saccharin pellets Expiratory nasal flow using spirometry
Nasal volume, volume of sinus fluids and other radiological changes.
Medication score
Adverse reactions and discomfort with procedure
 
The outcome measures will be checked on Day 0 (baseline), Day 10 (mid intervention) and Day 21 (post intervention). 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   02/01/2012 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Upper respiratory conditions, including acute and chronic rhinosinusitis, viral upper respiratory infection (URI) and allergic rhinitis, are common disorders with significant patient and societal impact. Common symptoms include fever, sore throat and nasal congestion. These symptoms are often painful and debilitating, and are a major cause of absenteeism  in the workplace. The economic impact of the common cold alone on workplace absenteeism is estimated to be billions of dollars  .

The conventional line of treatments for upper respiratory tract infection (URTIs) include antipyretic and analgesic drugs, mucolytics, expectorants and decongestants .Even tough acute URTI are viral in origin antibiotics are often prescribed   thereby increasing the chances for antibiotic resistance and adverse reactions. Use of such treatment needs long term approach which increases the chances of adverse reactions associated with chronic use of such medications. Patients who do not want to receive such long-term medication often seek complementary and alternative therapies.(CAM).

There are very few scientific studies about jalneti .But there are few studies on effect of

Nasal irrigation in treating diseases of upper respiratory tract. Saline irrigation of the nose, which is a popular treatment for sinonasal conditions, is believed to alleviate URTI symptoms by clearing excess mucus, reducing congestion and improving breathing . Studies have also shown its beneficial effect by improving mucociliary clearance by increasing the ciliary beat frequency . Beside relieving sinonasal symptoms, saline irrigation may remove infectious material from the sinuses, and reduce cough associated with postnasal drip  Studies have shown the beneficial effect of nasal irrigation in treatment of rhinosinusitis  as well as allergic rhinitis .the method adopted for nasal irrigation in studies was to irrigate the nose with 150 mL saline water through each nostril daily for 6 months with the nasal cup containing 2.0% saline buffered with baking soda.

Liquid and spray Saline Nasal Irrigation (SNI) has been evaluated for the treatment and prevention of viral URI . An RCT of 200 adults with viral URI showed that subjects treated with micronized saline, compared to liquid SNI, had improved rhinometric resistance, nasal volume, mucociliary transit time and symptom severity scores . One RCT of 60 adults evaluated spray SNI as preventive therapy for viral URI  In this study, those receiving a preventive daily spray SNI reported significantly fewer episodes of URIs, shorter symptom duration and fewer days with nasal symptoms compared to those without a preventive SNI care. Hypertonic saline nasal irrigation (HSNI) is an adjunctive therapy for rhinosinusitis and sinus symptoms.11 It flushes the nasal cavity, facilitating the evacuation of potentially allergen- and irritant-containing mucus.

Yoga has explained six kriyas to purify the bodies which are called as shatkriyas. Out of the shatkriyas, the kriya which is meant for the cleaning of the nasal path is known as neti. when this neti is performed using water this is called as  jalaneti. The aim of this process is to purify the nasal tract. In this process the water simply flows up one nostril to just above the bridge of the nose where the usual air flows meet, backwards into the middle cavity and then the water flows down and out the other side of the nose. In this route, it passes by the frontal and mid nasal sinuses This way Jala Neti rinses mucosal lining as the warm water loosens and dissolves any internal build up of nasal secretions and takes them outwards at the same time sensitizing the nasocilairy mucosal lining that is rich in nerve endings.

This method of nasal irrigation is found to be very similar to that of jalaneti. Hence similar results and mechanism of action can even be expected by jalneti also. Jalneti is generally followed by kapalabhati which also aids in removal of residual water from the upper respiratory tract .beside this it also helps in proper cleaning and aeration of the upper respiratory tract .As poor aeration of sinuses is considered to be a predisposing factor for repeated infections addition of kapalabhati to Jalneti can have a synergistic effect in treating diseases of upper respiratory tract. Hence the present research work is planned to evaluate the efficacy of yogic technique of Jalneti and kapalabhati in treating diseases of upper respiratory tract

 
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