CTRI Number |
CTRI/2017/09/009900 [Registered on: 25/09/2017] Trial Registered Prospectively |
Last Modified On: |
26/02/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
A clinical trial to study the effects of Yoga based cleansing methods on people suffering from recurrent cold and cough. |
Scientific Title of Study
|
A randomized controlled trial on “the effects of shuddhi Kriyas based yoga program on allergic rhinitis†|
Trial Acronym |
SKYP |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rajesh SK |
Designation |
Assistant Professor |
Affiliation |
Swami Vivekananda Yoga University |
Address |
Division of Yoga and Physical Sciences
Swami Vivekananda Yoga University [SVYASA]
19 Eknath Bhavan
Gavipuram Circle
K G Nagar
Bangalore KARNATAKA 560 019 India |
Phone |
9844118748 |
Fax |
8022639918 |
Email |
rajesheskay@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ripudaman Singh Chauhan |
Designation |
PhD scholar, Division of life sciences |
Affiliation |
Morarji Desai Institute of NAturopathy and Yogic sciences |
Address |
Balwantray Mehta Arogya Bhavan Near Keshav Garden
Karelibaug
Vadodara GUJARAT 390022 India |
Phone |
8141092382 |
Fax |
|
Email |
drripudaman84@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ripudaman Singh Chauhan |
Designation |
PhD scholar, Division of life sciences |
Affiliation |
Morarji Desai Institute of NAturopathy and Yogic sciences |
Address |
Balwantray Mehta Arogya Bhavan Near Keshav Garden
Karelibaug
Vadodara GUJARAT 390022 India |
Phone |
8141092382 |
Fax |
|
Email |
drripudaman84@gmail.com |
|
Source of Monetary or Material Support
|
Svyasa University Banglore,
Morarji Desai Institute of naturopathy & Yogic sciences, Vadodara |
|
Primary Sponsor
|
Name |
Swami Vivekananda Yoga University |
Address |
19 Eknath Bhavan
Gavipuram Circle
K.G.Nagar
Bangalore Krnataka
Bangalore
|
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
Name |
Address |
Morarji desai Institute of naturopathy Yogic Sciences |
Opp- RR park, Anand Nager, Water tank road, Karelibaug,Vadodara,Gujarat-390022 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Ripudaman singh |
Morarji Desai Institute of Naturopathy & Yogic Sciences |
Yoga Hall, Division of Yoga,
Morarji Desai college Vadodara GUJARAT |
8141092382 2652481623 drripudaman84@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, Svyasa Banglore |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, (2) ICD-10 Condition: J309||Allergic rhinitis, unspecified, (3) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Control group will be continued with their current medicines as per the advice of their physician. |
patients will be asked to continue their present treatment and medicines but any changes in dosage and symptoms will be noted timely. |
Intervention |
Shuddhi Kriya based Yoga Program. |
Yoga class specially focussed on Shuddhi kriyas along with sukshma kriyas, stretching & bending asanas,Pranayama, Relaxation and Meditation. Shuddhi kriyas- Laghu sankhprakshalana,Neti,Vaman Dhauti,kapalbhati etc. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
41.00 Year(s) |
Gender |
Both |
Details |
Those who clinically diagnosed with Allergic rhinitis, based upon symptoms according to criteria proposed in the “International Consensus on Diagnosis and Management of Rhinitis (1994)â€: Allergic Rhinitis could be seasonal or perennial, infectious or others.
Those who have typical symptoms of AR including rhinorrhea, sneezing, nasal obstruction for at least 2 previous consecutive years.
|
|
ExclusionCriteria |
Details |
Nasal polyp.
Deviated nasal septum which is not suitable for entry of rubber catheter/Sutra.
Rhinitis medicaments.
Those who are under treatment with Systemic corticosteroid for any other disorder.
Patients receiving immunotherapy within the previous 2 years.
Subject with any history of Epistaxis.
CSF rhinorrhea
Hypertension & heart disease, renal disease, hepatic impairments, cancer or other active medical problem
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
TNSS, Anosmia, headache, fatigability and irritability
Changes in the dosage of medication
Biochemical changes- IgE, AEC,ESR
Nasal swab smear test
|
9th week, 25th week |
|
Secondary Outcome
|
Outcome |
TimePoints |
Quality of life Assessment tools -SQI,RQLQ,WPAI: SHP
Clinical Assessment tools-
PNIF,PEFR, |
Before Trial And
two months after commencement of Trail |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
13/10/2017 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Allergic rhinitis is very common nowadays making it difficult for the patients to work in their full efficiency during diseased condition it reduces productivity and quality of life. Even being very prevalent in the society it is mostly underdiagnosed till it do not cause other associated problems. There are numbers of methods of alternative medicine to relieve symptoms yogic management is being one of them. Yoga is more holistic because it has components like Kriyas (cleansing techniques), Asana (physical exercise), Pranayama (breathing exercise) and meditation. We are doing this research to find out if Shuddhi Kriya Based Yoga Program is effective for Allergic Rhinitis patients when done properly on Physical, Biochemical and Psychological profile of patients. Previous intervention studies on allergic rhinitis have been using pharmacological agents and have shown high effect sizes. (> 0.7) [give reference], however, in the present study, we plan to use non-pharmacological means (yoga practices and nasal wash technique) and therefore have fixed a conservative estimate of the effect size of 0.5 and with an alpha of 0.5 and power of 0.8 the sample size in each group is calculated to be 26. And considering 20% dropout, we will recruit 30 in each group so the total sample size would be 30+30= 60 no. of Subjects. |