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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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. |