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Clinical Trials/CTRI/2011/12/002289
CTRI/2011/12/002289Not yet recruitingUnknown

Effect of Yogic kriyas and pranayama in managing symptoms of rhino sinusitis

Institute of Naturopathy and Yogic sciences Medical Research societyINYSMRS1 site in 1 country100 target enrollmentStarted: February 1, 2012Last updated:

Trial Snapshot

Phase
Unknown
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Evaluation of symptoms by SNOT and Total Nasal Symptom Score

Study Overview

Brief Summary

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

The conventionalline of treatments for upper respiratory tract infection (URTIs) includeantipyretic and analgesic drugs, mucolytics, expectorants and decongestants .Even tough acute URTI are viral in origin antibiotics are oftenprescribed  therebyincreasing the chances for antibiotic resistance and adverse reactions. Useof such treatment needs long term approach which increases the chances ofadverse reactions associated with chronic use of such medications. Patients whodo not want to receive such long-term medication often seek complementary andalternative therapies.(CAM).

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

Nasal irrigation in treating diseases of upper respiratorytract. Saline irrigation of the nose, which is a popular treatment forsinonasal conditions, is believed to alleviate URTI symptoms by clearing excessmucus, reducing congestion and improving breathing . Studies havealso shown its beneficial effect by improving mucociliary clearance byincreasing the ciliary beat frequency . Beside relieving sinonasalsymptoms, saline irrigation may remove infectious material from the sinuses,and reduce cough associated with postnasal drip  Studies haveshown the beneficial effect of nasal irrigation in treatment of rhinosinusitis as well as allergic rhinitis .the method adopted for nasalirrigation in studies was to irrigate the nose with 150 mL saline water througheach nostril daily for 6 months with the nasal cup containing 2.0% salinebuffered with baking soda.

Liquid and spray Saline Nasal Irrigation (SNI) has beenevaluated for the treatment and prevention of viral URI . An RCT of200 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 of60 adults evaluated spray SNI as preventive therapy for viral URI Inthis study, those receiving a preventive daily spray SNI reported significantlyfewer episodes of URIs, shorter symptom duration and fewer days with nasalsymptoms compared to those without a preventive SNI care. Hypertonic salinenasal irrigation (HSNI) is an adjunctive therapy for rhinosinusitis and sinussymptoms.11 It flushes the nasal cavity, facilitating the evacuationof potentially allergen- and irritant-containing mucus.

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

This method of nasal irrigation is found to be verysimilar to that of jalaneti. Hence similar results and mechanism of action caneven be expected by jalneti also. Jalneti is generally followed by kapalabhatiwhich 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 respiratorytract .As poor aeration of sinuses is considered to be a predisposing factorfor repeated infections addition of kapalabhati to Jalneti can have asynergistic effect in treating diseases of upper respiratory tract. Hence thepresent research work is planned to evaluate the efficacy of yogic technique ofJalneti and kapalabhati in treating diseases of upper respiratory tract

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Evaluation of symptoms by SNOT and Total Nasal Symptom Score

Time Frame: The outcome measures will be checked on Day 0 (baseline), Day 10 (mid intervention) and Day 21 (post intervention).

Secondary Outcomes

  • Mucociliary Transit time using Saccharin pellets Expiratory nasal flow using spirometry(Nasal volume, volume of sinus fluids and other radiological changes.)

Investigators

Sponsor
Institute of Naturopathy and Yogic sciences Medical Research societyINYSMRS
Sponsor Class
Research institution

Study Sites (1)

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