| 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
|
|
|
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
|
|
|
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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